<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022292</url>
  </required_header>
  <id_info>
    <org_study_id>16-000925</org_study_id>
    <nct_id>NCT03022292</nct_id>
  </id_info>
  <brief_title>The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy</brief_title>
  <acronym>IAI-OCTA</acronym>
  <official_title>The IAI-OCTA Study or; Microvascular Structure and Morphology of Neovascular Membranes in Age Related Macular Degeneration (AMD) After Intravitreal Aflibercept Injection (IAI) Therapy Using OCT-Angiography Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study investigating the ability of OCTA imaging technology to identify and analyze&#xD;
      untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with&#xD;
      exudative macular degeneration, as well as investigating the ability of the OCTA imaging&#xD;
      technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in&#xD;
      neovascular lesions associated with macular degeneration.&#xD;
&#xD;
      This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography&#xD;
      by Optovue) to image and evaluate the treatment outcomes of using standard of care&#xD;
      Intravitreal Aflibercept Injections for their approved use in patients diagnosed with&#xD;
      neovascular AMD who are naive to previous Anti-VEGF therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective study of neovascular AMD subjects with type 1, 2, or 3 neovascularization that&#xD;
      have not been treated with prior anti-VEGF therapy. Subjects will be scheduled for&#xD;
      intravitreal aflibercept injection (IAI) at baseline, week 4, week 8, week 16, week 24, week&#xD;
      36, and week 48. Additional injections can be administered during the remaining visits on an&#xD;
      as needed basis per PI discretion based on the presence of any intraretinal or subretinal&#xD;
      fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters,&#xD;
      or evidence of either increased area, density, or activity of the brush border of the&#xD;
      neovascularization on OCT angiography. There will be a minimum of 21 days between subsequent&#xD;
      injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum&#xD;
      of 13 injections throughout the study period. No injection will be given on the exit visit,&#xD;
      week 52. OCT angiography and spectral domain OCT imaging will be performed at baseline and&#xD;
      every 4 weeks thereafter&#xD;
&#xD;
      The above procedures are standard of care for neovascular AMD subjects.&#xD;
&#xD;
      As part of this study, these subjects will also undergo imaging of both eyes with OCTA at&#xD;
      each visit. This is not standard of Care and is research.&#xD;
&#xD;
      The only procedure that is being performed for research is the OCT-A. The injections and all&#xD;
      other procedure are SOC based on physician discretion and clinical need. The investigators&#xD;
      will not be modifying the dosage amounts or frequency.&#xD;
&#xD;
      A subgroup of willing subjects will undergo OCT angiography every 2 weeks for the first 12&#xD;
      weeks.&#xD;
&#xD;
      Indocyanine green angiography will be performed at baseline for all subjects to establish&#xD;
      baseline subject population characteristics. Fluorescein angiography will be performed at&#xD;
      baseline, week 12, and week 52 for efficacy monitoring. Detailed OCT angiography analysis&#xD;
      will be performed to identify anatomical and morphological biomarkers of growth progression&#xD;
      and disease activity. In addition to qualitative structural and morphological analysis,&#xD;
      detailed quantitative OCT angiography analysis of the neovascular lesion using automated or&#xD;
      manual capillary density maps and area calculation will be performed at each visit to&#xD;
      determine the detailed microvascular response of neovascular complexes to IAI therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.</measure>
    <time_frame>Week 24</time_frame>
    <description>Area of the neovascular lesion (in millimeters^2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.</measure>
    <time_frame>Week 52</time_frame>
    <description>Area of the neovascular lesion (in millimeters^2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change</measure>
    <time_frame>Week 24, Week 52</time_frame>
    <description>patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Week 24</time_frame>
    <description>Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Week 52</time_frame>
    <description>Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>OCTA Neovascular Membrane Regression Ratio of Change</measure>
    <time_frame>12 weeks</time_frame>
    <description>OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters^2) during the initial 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</measure>
    <time_frame>week 24</time_frame>
    <description>Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)</description>
  </other_outcome>
  <other_outcome>
    <measure>SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM)</measure>
    <time_frame>week 52</time_frame>
    <description>Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)</description>
  </other_outcome>
  <other_outcome>
    <measure>Ocular AE</measure>
    <time_frame>52 weeks</time_frame>
    <description>ocular adverse events</description>
  </other_outcome>
  <other_outcome>
    <measure>Relevant Systemic SAE</measure>
    <time_frame>52 weeks</time_frame>
    <description>relevant systemic serious adverse events</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Injections</measure>
    <time_frame>week 24</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Injections</measure>
    <time_frame>week 52</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>OCTA Neovascular Membrane Biomarker Qualitative Analysis (Sub-study)</measure>
    <time_frame>Week 1-12</time_frame>
    <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>SD OCT Analysis of Central Macular Thickness</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.</description>
  </other_outcome>
  <other_outcome>
    <measure>SD OCT Analysis of Central Macular Thickness</measure>
    <time_frame>Baseline to week 52</time_frame>
    <description>Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.</description>
  </other_outcome>
  <other_outcome>
    <measure>OCTA Analysis of Vessel Density</measure>
    <time_frame>24 weeks</time_frame>
    <description>OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value.</description>
  </other_outcome>
  <other_outcome>
    <measure>OCTA Neovascular Membrane Biomarker Qualitative Analysis of Flow-void Areas(Sub-study)</measure>
    <time_frame>Week 1-12</time_frame>
    <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>OCTA Neovascular Membrane Biomarker Qualitative Analysis of Vessel Looping (Sub-study)</measure>
    <time_frame>Week 1-12</time_frame>
    <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>SD OCT Analysis of SRF Volume</measure>
    <time_frame>week 24 and 52</time_frame>
    <description>Change in volume of subretinal fluid</description>
  </other_outcome>
  <other_outcome>
    <measure>SD OCT Analysis of SHRM Volume</measure>
    <time_frame>week 24 and 52</time_frame>
    <description>Change volume of SHRM</description>
  </other_outcome>
  <other_outcome>
    <measure>Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</measure>
    <time_frame>week 24</time_frame>
    <description>Participants with presence of cystoid macular edema</description>
  </other_outcome>
  <other_outcome>
    <measure>Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</measure>
    <time_frame>week 52</time_frame>
    <description>Participants with presence of cystoid macular edema</description>
  </other_outcome>
  <other_outcome>
    <measure>Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value.</description>
  </other_outcome>
  <other_outcome>
    <measure>PED Volume as Determined by SD OCT Analysis</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Change in ratio of volume of PED, calculated as change from baseline divided by baseline value.</description>
  </other_outcome>
  <other_outcome>
    <measure>PED Height as Determined by SD OCT Analysis</measure>
    <time_frame>Baseline, week 24</time_frame>
    <description>Ratio of change in height of PED, calculated as change from baseline divided by baseline value</description>
  </other_outcome>
  <other_outcome>
    <measure>PED Height as Determined by SD OCT Analysis</measure>
    <time_frame>Baseline, week 52</time_frame>
    <description>Ratio of change in height of PED, calculated as change from baseline divided by baseline value</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Wet Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>IAI Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Additional injections can be administered during the remaining visits on an as needed basis per Primary Investigator (PI) discretion based on the presence of any intraretinal or subretinal fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters, or evidence of either increased area, density, or activity of the brush border of the neovascularization on OCT-angiography. There will be a minimum of 21 days between subsequent injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum of 13 injections throughout the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept Ophthalmic</intervention_name>
    <description>IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC</description>
    <arm_group_label>IAI Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>optovue angiovue</intervention_name>
    <description>FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
    <arm_group_label>IAI Treatment</arm_group_label>
    <other_name>OCTA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is older than 50 years of age.&#xD;
&#xD;
          2. Subject is willing to participate in the study and able to follow the study criteria&#xD;
             and protocol.&#xD;
&#xD;
          3. The study eye is treatment naive regarding treatment of neovascular AMD.&#xD;
&#xD;
          4. Subject is willing and able to comply with clinic visits and study-related procedures.&#xD;
&#xD;
          5. Subject is able to provide signed informed consent.&#xD;
&#xD;
          6. Subject is able to understand and complete study-related questionnaires.&#xD;
&#xD;
          7. The subject is not currently involved with any other clinical study.&#xD;
&#xD;
          8. Best Corrected Visual Acuity (BCVA) with ETDRS Snellen equivalent of 20/400 or better&#xD;
             and 20/32 or worse.&#xD;
&#xD;
          9. Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and&#xD;
             fundus photography (FP).&#xD;
&#xD;
         10. Intraocular pressure (IOP) of 25mmHg or less in the study eye, with or without use of&#xD;
             ocular hypotensive agents.&#xD;
&#xD;
         11. Prior focal corticosteroid treatment is allowed, as long as the study eye is not&#xD;
             involved. However prior (within 90 days of Day 0) or current systemic corticosteroid&#xD;
             therapy (oral or intravenous corticosteroid treatment) is not permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any prior treatment of neovascular AMD in the eye proposed for enrollment including&#xD;
             previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy&#xD;
             (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV,&#xD;
             thermal laser treatment, and any other prior intravitreal treatment for neovascular&#xD;
             AMD (except minerals and vitamins).&#xD;
&#xD;
          2. Known serious allergies to aflibercept, fluorescein dye, Indocyanine Green (ICG),&#xD;
             shellfish, drugs for pupillary dilation, topical anesthetic, or sterilizing solution&#xD;
             (e.g. Betadine Solution).&#xD;
&#xD;
          3. Prior or current systemic anti-VEGF therapy.&#xD;
&#xD;
          4. Pregnant or breast-feeding women.&#xD;
&#xD;
          5. Sexually active men* or women of childbearing potential** who are unwilling to&#xD;
             practice adequate contraception during the study (adequate contraceptive measures&#xD;
             include stable use of oral contraceptives or other prescription pharmaceutical&#xD;
             contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device&#xD;
             [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or&#xD;
             jelly, or diaphragm plus contraceptive sponge, foam, or jelly).&#xD;
&#xD;
          6. Contraindication to pupillary dilation in study eye.&#xD;
&#xD;
          7. Any condition (including inability to read visual acuity charts, or language barrier)&#xD;
             that may preclude subjects ability to comply with the study protocol and requirements.&#xD;
&#xD;
          8. Presence of any advanced systemic condition or end-stage disease, such as advanced&#xD;
             Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from&#xD;
             completing study.&#xD;
&#xD;
          9. Previous therapeutic radiation in the region of the study eye.&#xD;
&#xD;
         10. Prior retinal pigment epithelial (RPE) tear in study eye.&#xD;
&#xD;
         11. Prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days.&#xD;
&#xD;
         12. Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.&#xD;
&#xD;
         13. Prior vitrectomy in the study eye.&#xD;
&#xD;
         14. Presence of any causes of CNV and PED other than due to AMD or presence of ocular&#xD;
             disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis&#xD;
             syndrome, android streaks, pathologic myopia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stein Eye Institute of UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.</citation>
    <PMID>15078664</PMID>
  </reference>
  <reference>
    <citation>Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Aug 29;8(8):CD005139. doi: 10.1002/14651858.CD005139.pub3.</citation>
    <PMID>25170575</PMID>
  </reference>
  <reference>
    <citation>Kuehlewein L, Bansal M, Lenis TL, Iafe NA, Sadda SR, Bonini Filho MA, De Carlo TE, Waheed NK, Duker JS, Sarraf D. Optical Coherence Tomography Angiography of Type 1 Neovascularization in Age-Related Macular Degeneration. Am J Ophthalmol. 2015 Oct;160(4):739-48.e2. doi: 10.1016/j.ajo.2015.06.030. Epub 2015 Jul 9.</citation>
    <PMID>26164826</PMID>
  </reference>
  <reference>
    <citation>Kuehlewein L, Dansingani KK, de Carlo TE, Bonini Filho MA, Iafe NA, Lenis TL, Freund KB, Waheed NK, Duker JS, Sadda SR, Sarraf D. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY OF TYPE 3 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2015 Nov;35(11):2229-35. doi: 10.1097/IAE.0000000000000835.</citation>
    <PMID>26502007</PMID>
  </reference>
  <reference>
    <citation>Miere A, Querques G, Semoun O, El Ameen A, Capuano V, Souied EH. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN EARLY TYPE 3 NEOVASCULARIZATION. Retina. 2015 Nov;35(11):2236-41. doi: 10.1097/IAE.0000000000000834.</citation>
    <PMID>26457399</PMID>
  </reference>
  <reference>
    <citation>El Ameen A, Cohen SY, Semoun O, Miere A, Srour M, Quaranta-El Maftouhi M, Oubraham H, Blanco-Garavito R, Querques G, Souied EH. TYPE 2 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION IMAGED BY OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2212-8. doi: 10.1097/IAE.0000000000000773.</citation>
    <PMID>26441269</PMID>
  </reference>
  <reference>
    <citation>Jia Y, Bailey ST, Wilson DJ, Tan O, Klein ML, Flaxel CJ, Potsaid B, Liu JJ, Lu CD, Kraus MF, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of choroidal neovascularization in age-related macular degeneration. Ophthalmology. 2014 Jul;121(7):1435-44. doi: 10.1016/j.ophtha.2014.01.034. Epub 2014 Mar 27.</citation>
    <PMID>24679442</PMID>
  </reference>
  <reference>
    <citation>Miere A, Semoun O, Cohen SY, El Ameen A, Srour M, Jung C, Oubraham H, Querques G, Souied EH. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY FEATURES OF SUBRETINAL FIBROSIS IN AGE-RELATED MACULAR DEGENERATION. Retina. 2015 Nov;35(11):2275-84. doi: 10.1097/IAE.0000000000000819.</citation>
    <PMID>26457397</PMID>
  </reference>
  <reference>
    <citation>Coscas G, Lupidi M, Coscas F, Francais C, Cagini C, Souied EH. Optical coherence tomography angiography during follow-up: qualitative and quantitative analysis of mixed type I and II choroidal neovascularization after vascular endothelial growth factor trap therapy. Ophthalmic Res. 2015;54(2):57-63. doi: 10.1159/000433547. Epub 2015 Jul 17.</citation>
    <PMID>26201877</PMID>
  </reference>
  <reference>
    <citation>Spaide RF. Optical Coherence Tomography Angiography Signs of Vascular Abnormalization With Antiangiogenic Therapy for Choroidal Neovascularization. Am J Ophthalmol. 2015 Jul;160(1):6-16. doi: 10.1016/j.ajo.2015.04.012. Epub 2015 Apr 14.</citation>
    <PMID>25887628</PMID>
  </reference>
  <reference>
    <citation>Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.</citation>
    <PMID>24084500</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>October 21, 2021</results_first_submitted>
  <results_first_submitted_qc>December 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2022</results_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>David Sarraf, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Wet Macular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03022292/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IAI Treatment</title>
          <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IAI Treatment</title>
          <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean BCVA in LogMAR</title>
          <description>Best Corrected Visual acuity (BCVA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
          <population>Measure includes all participants with analyzable baseline BCVA</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.32" lower_limit="-0.2" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>OCTA Analysis of Lesion Area</title>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.008" lower_limit="0" upper_limit="18.016"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.</title>
        <description>Area of the neovascular lesion (in millimeters^2)</description>
        <time_frame>Week 24</time_frame>
        <population>Participants present for 24 week assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.</title>
          <description>Area of the neovascular lesion (in millimeters^2)</description>
          <population>Participants present for 24 week assessment</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" lower_limit="0" upper_limit="9.939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.</title>
        <description>Area of the neovascular lesion (in millimeters^2)</description>
        <time_frame>Week 52</time_frame>
        <population>Participants present for 52 week assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.</title>
          <description>Area of the neovascular lesion (in millimeters^2)</description>
          <population>Participants present for 52 week assessment</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" lower_limit="0" upper_limit="6.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change</title>
        <description>patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Participants with analyzable ETDRS at both baseline &amp; week 24</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change</title>
          <description>patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).</description>
          <population>Participants with analyzable ETDRS at both baseline &amp; week 24</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥5 ETDRS letters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥10 ETDRS letters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥15 ETDRS letters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change</title>
        <description>patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).</description>
        <time_frame>Week 24, Week 52</time_frame>
        <population>Participants with analyzable BCVA at both 24 and 52 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change</title>
          <description>patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).</description>
          <population>Participants with analyzable BCVA at both 24 and 52 weeks</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥5 ETDRS letters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥10 ETDRS letters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥15 ETDRS letters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Best Corrected Visual Acuity (BCVA)</title>
        <description>Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
        <time_frame>Week 24</time_frame>
        <population>Participants with analyzable measure at week 24</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Best Corrected Visual Acuity (BCVA)</title>
          <description>Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
          <population>Participants with analyzable measure at week 24</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="-0.2" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Best Corrected Visual Acuity (BCVA)</title>
        <description>Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
        <time_frame>Week 52</time_frame>
        <population>Participants with analyzable BCVA at 52 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Best Corrected Visual Acuity (BCVA)</title>
          <description>Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.</description>
          <population>Participants with analyzable BCVA at 52 weeks</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" lower_limit="-0.2" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>OCTA Neovascular Membrane Regression Ratio of Change</title>
        <description>OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters^2) during the initial 12 weeks</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>OCTA Neovascular Membrane Regression Ratio of Change</title>
          <description>OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters^2) during the initial 12 weeks</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" lower_limit="0.14" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</title>
        <description>Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)</description>
        <time_frame>week 24</time_frame>
        <population>Participants present for assessment at week 24</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</title>
          <description>Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)</description>
          <population>Participants present for assessment at week 24</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>intraretinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>subretinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SHRM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM)</title>
        <description>Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)</description>
        <time_frame>week 52</time_frame>
        <population>Participants present for assessment at 52 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM)</title>
          <description>Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)</description>
          <population>Participants present for assessment at 52 weeks</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>intraretinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>subretinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SHRM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ocular AE</title>
        <description>ocular adverse events</description>
        <time_frame>52 weeks</time_frame>
        <population>All participants at risk for AE</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular AE</title>
          <description>ocular adverse events</description>
          <population>All participants at risk for AE</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Relevant Systemic SAE</title>
        <description>relevant systemic serious adverse events</description>
        <time_frame>52 weeks</time_frame>
        <population>Participants at risk for AE during study</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Relevant Systemic SAE</title>
          <description>relevant systemic serious adverse events</description>
          <population>Participants at risk for AE during study</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Injections</title>
        <time_frame>week 24</time_frame>
        <population>Participants present at week 24 visit</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Injections</title>
          <population>Participants present at week 24 visit</population>
          <units>injections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Injections</title>
        <time_frame>week 52</time_frame>
        <population>Participants present for week 52 visit</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Injections</title>
          <population>Participants present for week 52 visit</population>
          <units>injections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>OCTA Neovascular Membrane Biomarker Qualitative Analysis (Sub-study)</title>
        <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks</description>
        <time_frame>Week 1-12</time_frame>
        <population>Qualitative analyses not performed due to study staff turnover and lack of expertise</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>OCTA Neovascular Membrane Biomarker Qualitative Analysis (Sub-study)</title>
          <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks</description>
          <population>Qualitative analyses not performed due to study staff turnover and lack of expertise</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>SD OCT Analysis of Central Macular Thickness</title>
        <description>Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>Participants present for both baseline and week 24 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>SD OCT Analysis of Central Macular Thickness</title>
          <description>Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.</description>
          <population>Participants present for both baseline and week 24 assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>SD OCT Analysis of Central Macular Thickness</title>
        <description>Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.</description>
        <time_frame>Baseline to week 52</time_frame>
        <population>Participants present for both baseline and week 52 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>SD OCT Analysis of Central Macular Thickness</title>
          <description>Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.</description>
          <population>Participants present for both baseline and week 52 assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>OCTA Analysis of Vessel Density</title>
        <description>OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value.</description>
        <time_frame>24 weeks</time_frame>
        <population>Participants present for both baseline and 24 week assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>OCTA Analysis of Vessel Density</title>
          <description>OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value.</description>
          <population>Participants present for both baseline and 24 week assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="2.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>OCTA Neovascular Membrane Biomarker Qualitative Analysis of Flow-void Areas(Sub-study)</title>
        <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks</description>
        <time_frame>Week 1-12</time_frame>
        <population>Qualitative analyses not performed due to study staff turnover and lack of expertise</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>OCTA Neovascular Membrane Biomarker Qualitative Analysis of Flow-void Areas(Sub-study)</title>
          <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks</description>
          <population>Qualitative analyses not performed due to study staff turnover and lack of expertise</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>OCTA Neovascular Membrane Biomarker Qualitative Analysis of Vessel Looping (Sub-study)</title>
        <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks</description>
        <time_frame>Week 1-12</time_frame>
        <population>Qualitative analyses not performed due to study staff turnover and lack of expertise</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>OCTA Neovascular Membrane Biomarker Qualitative Analysis of Vessel Looping (Sub-study)</title>
          <description>In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks</description>
          <population>Qualitative analyses not performed due to study staff turnover and lack of expertise</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>SD OCT Analysis of SRF Volume</title>
        <description>Change in volume of subretinal fluid</description>
        <time_frame>week 24 and 52</time_frame>
        <population>Fluid volume measures not performed due to study staff turnover and lack of expertise</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>SD OCT Analysis of SRF Volume</title>
          <description>Change in volume of subretinal fluid</description>
          <population>Fluid volume measures not performed due to study staff turnover and lack of expertise</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>SD OCT Analysis of SHRM Volume</title>
        <description>Change volume of SHRM</description>
        <time_frame>week 24 and 52</time_frame>
        <population>Fluid volume measures not performed due to study staff turnover and lack of expertise</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>SD OCT Analysis of SHRM Volume</title>
          <description>Change volume of SHRM</description>
          <population>Fluid volume measures not performed due to study staff turnover and lack of expertise</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</title>
        <description>Participants with presence of cystoid macular edema</description>
        <time_frame>week 24</time_frame>
        <population>Participants assessed for CME at week 24</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</title>
          <description>Participants with presence of cystoid macular edema</description>
          <population>Participants assessed for CME at week 24</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</title>
        <description>Participants with presence of cystoid macular edema</description>
        <time_frame>week 52</time_frame>
        <population>Participants assessed for CME at week 52</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.</title>
          <description>Participants with presence of cystoid macular edema</description>
          <population>Participants assessed for CME at week 52</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis</title>
        <description>Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value.</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>Participants present for both baseline and week 24 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis</title>
          <description>Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value.</description>
          <population>Participants present for both baseline and week 24 assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PED Volume as Determined by SD OCT Analysis</title>
        <description>Change in ratio of volume of PED, calculated as change from baseline divided by baseline value.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>Participants present for both baseline and week 52 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>PED Volume as Determined by SD OCT Analysis</title>
          <description>Change in ratio of volume of PED, calculated as change from baseline divided by baseline value.</description>
          <population>Participants present for both baseline and week 52 assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PED Height as Determined by SD OCT Analysis</title>
        <description>Ratio of change in height of PED, calculated as change from baseline divided by baseline value</description>
        <time_frame>Baseline, week 24</time_frame>
        <population>Participants present for both baseline and week 24 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>PED Height as Determined by SD OCT Analysis</title>
          <description>Ratio of change in height of PED, calculated as change from baseline divided by baseline value</description>
          <population>Participants present for both baseline and week 24 assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.03" upper_limit="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PED Height as Determined by SD OCT Analysis</title>
        <description>Ratio of change in height of PED, calculated as change from baseline divided by baseline value</description>
        <time_frame>Baseline, week 52</time_frame>
        <population>Participants present for both baseline and week 52 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>IAI Treatment</title>
            <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
          </group>
        </group_list>
        <measure>
          <title>PED Height as Determined by SD OCT Analysis</title>
          <description>Ratio of change in height of PED, calculated as change from baseline divided by baseline value</description>
          <population>Participants present for both baseline and week 52 assessment</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" lower_limit="0.12" upper_limit="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>52 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IAI Treatment</title>
          <description>Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.&#xD;
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC&#xD;
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. David Sarraf</name_or_title>
      <organization>Stein Eye Institute of UCLA</organization>
      <phone>310-825-7836</phone>
      <email>DSarraf@ucla.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022292
org study id: 16-000925
nct id: NCT03022292
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
A study investigating the ability of OCTA imaging technology to identify and analyze
      untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with
      exudative macular degeneration, as well as investigating the ability of the OCTA imaging
      technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in
      neovascular lesions associated with macular degeneration.

      This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography
      by Optovue) to image and evaluate the treatment outcomes of using standard of care
      Intravitreal Aflibercept Injections for their approved use in patients diagnosed with
      neovascular AMD who are naive to previous Anti-VEGF therapies.
Prospective study of neovascular AMD subjects with type 1, 2, or 3 neovascularization that
      have not been treated with prior anti-VEGF therapy. Subjects will be scheduled for
      intravitreal aflibercept injection (IAI) at baseline, week 4, week 8, week 16, week 24, week
      36, and week 48. Additional injections can be administered during the remaining visits on an
      as needed basis per PI discretion based on the presence of any intraretinal or subretinal
      fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters,
      or evidence of either increased area, density, or activity of the brush border of the
      neovascularization on OCT angiography. There will be a minimum of 21 days between subsequent
      injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum
      of 13 injections throughout the study period. No injection will be given on the exit visit,
      week 52. OCT angiography and spectral domain OCT imaging will be performed at baseline and
      every 4 weeks thereafter

      The above procedures are standard of care for neovascular AMD subjects.

      As part of this study, these subjects will also undergo imaging of both eyes with OCTA at
      each visit. This is not standard of Care and is research.

      The only procedure that is being performed for research is the OCT-A. The injections and all
      other procedure are SOC based on physician discretion and clinical need. The investigators
      will not be modifying the dosage amounts or frequency.

      A subgroup of willing subjects will undergo OCT angiography every 2 weeks for the first 12
      weeks.

      Indocyanine green angiography will be performed at baseline for all subjects to establish
      baseline subject population characteristics. Fluorescein angiography will be performed at
      baseline, week 12, and week 52 for efficacy monitoring. Detailed OCT angiography analysis
      will be performed to identify anatomical and morphological biomarkers of growth progression
      and disease activity. In addition to qualitative structural and morphological analysis,
      detailed quantitative OCT angiography analysis of the neovascular lesion using automated or
      manual capillary density maps and area calculation will be performed at each visit to
      determine the detailed microvascular response of neovascular complexes to IAI therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.
time frame: Week 24
description: Area of the neovascular lesion (in millimeters^2)
measure: Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.
time frame: Week 52
description: Area of the neovascular lesion (in millimeters^2)
measure: Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change
time frame: Baseline, Week 24
description: patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).
measure: Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change
time frame: Week 24, Week 52
description: patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).
measure: Mean Best Corrected Visual Acuity (BCVA)
time frame: Week 24
description: Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
measure: Mean Best Corrected Visual Acuity (BCVA)
time frame: Week 52
description: Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
measure: OCTA Neovascular Membrane Regression Ratio of Change
time frame: 12 weeks
description: OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters^2) during the initial 12 weeks
measure: Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.
time frame: week 24
description: Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)
measure: SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM)
time frame: week 52
description: Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)
measure: Ocular AE
time frame: 52 weeks
description: ocular adverse events
measure: Relevant Systemic SAE
time frame: 52 weeks
description: relevant systemic serious adverse events
measure: Number of Injections
time frame: week 24
measure: Number of Injections
time frame: week 52
measure: OCTA Neovascular Membrane Biomarker Qualitative Analysis (Sub-study)
time frame: Week 1-12
description: In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks
measure: SD OCT Analysis of Central Macular Thickness
time frame: Baseline to week 24
description: Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.
measure: SD OCT Analysis of Central Macular Thickness
time frame: Baseline to week 52
description: Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.
measure: OCTA Analysis of Vessel Density
time frame: 24 weeks
description: OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value.
measure: OCTA Neovascular Membrane Biomarker Qualitative Analysis of Flow-void Areas(Sub-study)
time frame: Week 1-12
description: In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks
measure: OCTA Neovascular Membrane Biomarker Qualitative Analysis of Vessel Looping (Sub-study)
time frame: Week 1-12
description: In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks
measure: SD OCT Analysis of SRF Volume
time frame: week 24 and 52
description: Change in volume of subretinal fluid
measure: SD OCT Analysis of SHRM Volume
time frame: week 24 and 52
description: Change volume of SHRM
measure: Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.
time frame: week 24
description: Participants with presence of cystoid macular edema
measure: Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.
time frame: week 52
description: Participants with presence of cystoid macular edema
measure: Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis
time frame: Baseline to week 24
description: Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value.
measure: PED Volume as Determined by SD OCT Analysis
time frame: Baseline to Week 52
description: Change in ratio of volume of PED, calculated as change from baseline divided by baseline value.
measure: PED Height as Determined by SD OCT Analysis
time frame: Baseline, week 24
description: Ratio of change in height of PED, calculated as change from baseline divided by baseline value
measure: PED Height as Determined by SD OCT Analysis
time frame: Baseline, week 52
description: Ratio of change in height of PED, calculated as change from baseline divided by baseline value
arm group label: IAI Treatment
arm group type: Experimental
description: Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Additional injections can be administered during the remaining visits on an as needed basis per Primary Investigator (PI) discretion based on the presence of any intraretinal or subretinal fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters, or evidence of either increased area, density, or activity of the brush border of the neovascularization on OCT-angiography. There will be a minimum of 21 days between subsequent injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum of 13 injections throughout the study period.
intervention type: Drug
intervention name: Aflibercept Ophthalmic
description: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC
arm group label: IAI Treatment
intervention type: Device
intervention name: optovue angiovue
description: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
arm group label: IAI Treatment
other name: OCTA
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.
PMID: 15078664
citation: Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Aug 29;8(8):CD005139. doi: 10.1002/14651858.CD005139.pub3.
PMID: 25170575
citation: Kuehlewein L, Bansal M, Lenis TL, Iafe NA, Sadda SR, Bonini Filho MA, De Carlo TE, Waheed NK, Duker JS, Sarraf D. Optical Coherence Tomography Angiography of Type 1 Neovascularization in Age-Related Macular Degeneration. Am J Ophthalmol. 2015 Oct;160(4):739-48.e2. doi: 10.1016/j.ajo.2015.06.030. Epub 2015 Jul 9.
PMID: 26164826
citation: Kuehlewein L, Dansingani KK, de Carlo TE, Bonini Filho MA, Iafe NA, Lenis TL, Freund KB, Waheed NK, Duker JS, Sadda SR, Sarraf D. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY OF TYPE 3 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2015 Nov;35(11):2229-35. doi: 10.1097/IAE.0000000000000835.
PMID: 26502007
citation: Miere A, Querques G, Semoun O, El Ameen A, Capuano V, Souied EH. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN EARLY TYPE 3 NEOVASCULARIZATION. Retina. 2015 Nov;35(11):2236-41. doi: 10.1097/IAE.0000000000000834.
PMID: 26457399
citation: El Ameen A, Cohen SY, Semoun O, Miere A, Srour M, Quaranta-El Maftouhi M, Oubraham H, Blanco-Garavito R, Querques G, Souied EH. TYPE 2 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION IMAGED BY OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2212-8. doi: 10.1097/IAE.0000000000000773.
PMID: 26441269
citation: Jia Y, Bailey ST, Wilson DJ, Tan O, Klein ML, Flaxel CJ, Potsaid B, Liu JJ, Lu CD, Kraus MF, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of choroidal neovascularization in age-related macular degeneration. Ophthalmology. 2014 Jul;121(7):1435-44. doi: 10.1016/j.ophtha.2014.01.034. Epub 2014 Mar 27.
PMID: 24679442
citation: Miere A, Semoun O, Cohen SY, El Ameen A, Srour M, Jung C, Oubraham H, Querques G, Souied EH. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY FEATURES OF SUBRETINAL FIBROSIS IN AGE-RELATED MACULAR DEGENERATION. Retina. 2015 Nov;35(11):2275-84. doi: 10.1097/IAE.0000000000000819.
PMID: 26457397
citation: Coscas G, Lupidi M, Coscas F, Francais C, Cagini C, Souied EH. Optical coherence tomography angiography during follow-up: qualitative and quantitative analysis of mixed type I and II choroidal neovascularization after vascular endothelial growth factor trap therapy. Ophthalmic Res. 2015;54(2):57-63. doi: 10.1159/000433547. Epub 2015 Jul 17.
PMID: 26201877
citation: Spaide RF. Optical Coherence Tomography Angiography Signs of Vascular Abnormalization With Antiangiogenic Therapy for Choroidal Neovascularization. Am J Ophthalmol. 2015 Jul;160(1):6-16. doi: 10.1016/j.ajo.2015.04.012. Epub 2015 Apr 14.
PMID: 25887628
citation: Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.
PMID: 24084500
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: David Sarraf, MD
investigator title: Principal Investigator
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration
mesh term: Aflibercept
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 