<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/NCT01712035</url>
  </required_header>
  <id_info>
    <org_study_id>OHSU IRB #00008360</org_study_id>
    <nct_id>NCT01712035</nct_id>
  </id_info>
  <brief_title>Neovascular Age-related Macular Degeneration</brief_title>
  <acronym>NVAMD</acronym>
  <official_title>OCT Evaluation of Treated and Untreated Choroidal Neovascular Membranes in Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <brief_summary>
    <textblock>
      Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic&#xD;
      white Americans. Neovascular AMD is an advanced form of macular degeneration that&#xD;
      historically has accounted for the majority of vision loss related to AMD. The presence of&#xD;
      choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.&#xD;
      Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying&#xD;
      fibroblasts from the choroid perforating Bruch's membrane with extension either above or&#xD;
      below the retinal pigment epithelium. These neovascular complexes are associated with&#xD;
      hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and&#xD;
      vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular&#xD;
      endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of&#xD;
      choroidal neovascularization and to reduce vascular permeability.&#xD;
&#xD;
      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal&#xD;
      and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,&#xD;
      except that OCT measures the intensity of reflected light rather than acoustical waves.&#xD;
&#xD;
      This observational study will use OCT technology to study and compare the retinal and&#xD;
      choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment&#xD;
      naïve group and active treatment group.&#xD;
&#xD;
      The purpose of this study is to assess the utility of OCT angiography in the evaluation of&#xD;
      NVAMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 5, 2017</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with NVAMD receiving treatment who also have changed retinal/choroidal anatomy and/or blood flow compared to treatment naive NVAMD patients</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Treatment-active NVAMD</arm_group_label>
    <description>Patients with NVAMD who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-naive NVAMD</arm_group_label>
    <description>Individuals who have not received any treatment for neovascular AMD in the study eye</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults older than age 50 with clinical findings of neovascular AMD with clinical evidence&#xD;
        of active choroidal neovascular membrane&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of Neovascular AMD confirmed by fluorescein dye leakage on angiogram or&#xD;
             presence of at least one of the following on OCT: subretinal fluid, intraretinal&#xD;
             fluid, or sub-retinal pigment epithelial fluid.&#xD;
&#xD;
          -  Treatment naïve group consists of individuals who have not received any treatment for&#xD;
             neovascular AMD in the study eye&#xD;
&#xD;
          -  Active treatment group consists of individuals who have received treatment with an&#xD;
             anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
&#xD;
          -  Inability to maintain stable fixation for OCT imaging&#xD;
&#xD;
          -  Significant renal disease, defined as a history of chronic renal failure requiring&#xD;
             dialysis or kidney transplant.&#xD;
&#xD;
          -  A condition that, in the opinion of the investigator, would preclude participation in&#xD;
             the study (e.g., unstable medical status including blood pressure, cardiovascular&#xD;
             disease, and glycemic control).&#xD;
&#xD;
          -  Blood pressure &gt; 180/110 (systolic above 180 OR diastolic above 110). If blood&#xD;
             pressure is brought below 180/110 by anti-hypertensive treatment, subject can become&#xD;
             eligible.&#xD;
&#xD;
          -  Women of child-bearing potential: pregnant or lactating or intending to become&#xD;
             pregnant within the next 12 months due to unknown safety of fluorescein angiography.&#xD;
&#xD;
          -  Unable to ambulate and take tram from clinic to where OCT is located&#xD;
&#xD;
          -  Prior macular laser treatment&#xD;
&#xD;
          -  Subretinal hemorrhage or fibrosis &gt;50% of choroidal neovascular lesion&#xD;
&#xD;
          -  Visual acuity 20/200 or worse&#xD;
&#xD;
          -  An ocular condition is present such that, in the opinion of the investigator, may&#xD;
             alter the retinal anatomy (eg: epiretinal membrane)&#xD;
&#xD;
          -  An ocular condition is present (other than Neovascular AMD) that, in the opinion of&#xD;
             the investigator, might affect or alter visual acuity during the course of the study&#xD;
             (e.g., vein occlusion, uveitis or other ocular inflammatory disease, etc.).&#xD;
&#xD;
          -  Substantial cataract that, in the opinion of the investigator, is likely to be&#xD;
             decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity&#xD;
             to 20/40 or worse if eye was otherwise normal).&#xD;
&#xD;
          -  History of major ocular surgery (including vitrectomy, cataract extraction, scleral&#xD;
             buckle, any intraocular surgery, etc.) within prior 4 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>David Huang</investigator_full_name>
    <investigator_title>Steven T. Bailey, MD, Assistant Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Wet AMD</keyword>
  <keyword>Age-related macular degeneration</keyword>
  <keyword>Optical coherenece tomography</keyword>
  <keyword>Imaging</keyword>
  <keyword>Blood flow</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01712035
org study id: OHSU IRB #00008360
nct id: NCT01712035
lead sponsor: 
Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic
      white Americans. Neovascular AMD is an advanced form of macular degeneration that
      historically has accounted for the majority of vision loss related to AMD. The presence of
      choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.
      Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying
      fibroblasts from the choroid perforating Bruch's membrane with extension either above or
      below the retinal pigment epithelium. These neovascular complexes are associated with
      hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and
      vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular
      endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of
      choroidal neovascularization and to reduce vascular permeability.

      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal
      and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,
      except that OCT measures the intensity of reflected light rather than acoustical waves.

      This observational study will use OCT technology to study and compare the retinal and
      choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment
      naïve group and active treatment group.

      The purpose of this study is to assess the utility of OCT angiography in the evaluation of
      NVAMD.
observational model: Case-Control
time perspective: Prospective
measure: Number of patients with NVAMD receiving treatment who also have changed retinal/choroidal anatomy and/or blood flow compared to treatment naive NVAMD patients
time frame: 1 year
arm group label: Treatment-active NVAMD
description: Patients with NVAMD who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit
arm group label: Treatment-naive NVAMD
description: Individuals who have not received any treatment for neovascular AMD in the study eye
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: David Huang
investigator title: Steven T. Bailey, MD, Assistant Professor of Ophthalmology
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration