<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/NCT01724554</url>
  </required_header>
  <id_info>
    <org_study_id>ANDROID</org_study_id>
    <nct_id>NCT01724554</nct_id>
  </id_info>
  <brief_title>Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion</brief_title>
  <acronym>ANDROID</acronym>
  <official_title>A Single-center, Open-label Study Evaluating the Impact of Repeat Intravitreal Injections of Aflibercept on Capillary Non-Perfusion (CNP) in Subjects With Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ophthalmic Consultants of Boston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ophthalmic Consultants of Boston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal&#xD;
      Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or&#xD;
      Proliferative Diabetic Retinopathy (PDR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol available upon request.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Capillary Non-Perfusion</measure>
    <time_frame>12 months</time_frame>
    <description>To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Central Retinal Vein Occlusion</condition>
  <condition>Proliferative Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>Every Month Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Every Month, then Every Other Month</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravitreal Aflibercept Injection</intervention_name>
    <description>Aflibercept administered to the eye intravitreally either every month or every other month.</description>
    <arm_group_label>Every Month Treatment</arm_group_label>
    <arm_group_label>Every Month, then Every Other Month</arm_group_label>
    <other_name>IAI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of one or more of the following:&#xD;
&#xD;
             Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease&#xD;
             secondary to CRVO (anterior segment or posterior segment neovascularization).&#xD;
&#xD;
          2. Be in need of IAI treatment, whether previously treated or treatment-naïve.&#xD;
&#xD;
          3. Age &gt; 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with macular edema secondary to diabetic retinopathy without concomitant&#xD;
             proliferative diabetic retinopathy.&#xD;
&#xD;
          2. Subjects with cataract or other media opacities impairing adequate visualization of&#xD;
             the retina to the extent that good quality images are impossible.&#xD;
&#xD;
          3. Presence of any substantial ocular disease (other than diabetic retinopathy or central&#xD;
             retinal vein occlusion) that may compromise vision in the study eye and /or confound&#xD;
             interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic&#xD;
             neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal&#xD;
             detachment, uveitis, viral or other forms of chorioretinitis, etc.&#xD;
&#xD;
          4. Active intraocular inflammation (grade trace or above) in the study eye, or history of&#xD;
             idiopathic or autoimmune-associated uveitis in either eye.&#xD;
&#xD;
          5. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg&#xD;
             despite treatment with anti-glaucoma medication).&#xD;
&#xD;
          6. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the&#xD;
             study eye.&#xD;
&#xD;
          7. Participation in a study of an investigational drug or device within 30 days prior to&#xD;
             potential enrollment into the study.&#xD;
&#xD;
          8. Intraocular surgery (including cataract surgery) in the study eye within 60 days&#xD;
             preceding baseline.&#xD;
&#xD;
          9. History of vitrectomy surgery in the study eye.&#xD;
&#xD;
         10. Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.&#xD;
&#xD;
         11. Subjects who received anti-VEGF therapy within 30 days of Screening or received&#xD;
             steroid or laser therapy within 90 days of Screening.&#xD;
&#xD;
         12. Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept&#xD;
&#xD;
         13. Pregnant or breast-feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey S Heier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ophthalmic Consultants of Boston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_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/NCT01724554
org study id: ANDROID
nct id: NCT01724554
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal
      Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or
      Proliferative Diabetic Retinopathy (PDR).
Protocol available upon request.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change in Capillary Non-Perfusion
time frame: 12 months
description: To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.
arm group label: Every Month Treatment
arm group type: Experimental
description: Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.
arm group label: Every Month, then Every Other Month
arm group type: Experimental
description: Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.
intervention type: Drug
intervention name: Intravitreal Aflibercept Injection
description: Aflibercept administered to the eye intravitreally either every month or every other month.
arm group label: Every Month Treatment
arm group label: Every Month, then Every Other Month
other name: IAI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey S Heier, MD
role: Principal Investigator
affiliation: Ophthalmic Consultants of Boston
facility: 
country: United States
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Retinal Vein Occlusion
mesh term: Aflibercept