<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/NCT04429503</url>
  </required_header>
  <id_info>
    <org_study_id>VGFTe-HD-DME-1934</org_study_id>
    <secondary_id>2019-003643-30</secondary_id>
    <nct_id>NCT04429503</nct_id>
  </id_info>
  <brief_title>Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease</brief_title>
  <acronym>PHOTON</acronym>
  <official_title>A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine if treatment with high-dose aflibercept&#xD;
      (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA)&#xD;
      compared to aflibercept dosed every 8 weeks.&#xD;
&#xD;
      The secondary objectives of the study are as follows:&#xD;
&#xD;
        -  To determine the effect of HD vs. aflibercept on anatomic and other visual measures of&#xD;
           response&#xD;
&#xD;
        -  To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">June 29, 2024</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in best corrected visual acuity (BCVA)</measure>
    <time_frame>At Week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with a ≥2 step improvement in Diabetic Retinopathy Severity Scale (DRSS)</measure>
    <time_frame>At Week 48</time_frame>
    <description>The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in best corrected visual acuity (BCVA) (region-specific analysis)</measure>
    <time_frame>At Week 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants gaining ≥15 letters</measure>
    <time_frame>At Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with BCVA ≥69 letters</measure>
    <time_frame>At Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants without fluid at foveal center</measure>
    <time_frame>At Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in central retinal thickness (CRT)</measure>
    <time_frame>At Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants without leakage on fluorescein angiography (FA)</measure>
    <time_frame>At Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score</measure>
    <time_frame>At Week 48</time_frame>
    <description>Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic pharmacokinetics (PK) of aflibercept as assessed by plasma concentrations</measure>
    <time_frame>Through Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response</measure>
    <time_frame>Through Week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by adverse events (AEs)</measure>
    <time_frame>Through Weeks 48, 60, 96 and 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by serious adverse events (SAEs)</measure>
    <time_frame>Through Weeks 48, 60, 96 and 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in BCVA for participants with both baseline and week 48 BCVA, in the analysis subset</measure>
    <time_frame>At Week 48</time_frame>
    <description>Per SAP Version 2.0 Appendix 10.9 for US Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from 8-weeks post initial treatment phase in BCVA for participants with both 8-weeks post initial treatment phase BCVA and week 48 BCVA, in the analysis subset</measure>
    <time_frame>At Week 48</time_frame>
    <description>Per SAP Version 2.0 Appendix 10.9 for US Only</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">660</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <condition>Type 1 Diabetes Mellitus</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>aflibercept Q8</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered every 8 weeks after a loading phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Dose aflibercept Q12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered every 12 weeks after a loading phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Dose aflibercept Q16</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered every 16 weeks after a loading phase</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aflibercept</intervention_name>
    <description>Intravitreally (IVT) administered as a liquid formulation in a vial</description>
    <arm_group_label>aflibercept Q8</arm_group_label>
    <other_name>EYLEA®</other_name>
    <other_name>BAY86-5321</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High-dose aflibercept</intervention_name>
    <description>Intravitreally (IVT) administered as a liquid formulation in a vial</description>
    <arm_group_label>High-Dose aflibercept Q12</arm_group_label>
    <arm_group_label>High-Dose aflibercept Q16</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic macular edema (DME) with central involvement in the study eye&#xD;
&#xD;
          -  Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS)&#xD;
             letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the&#xD;
             study eye with decreased vision determined to be primarily the result of DME&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          -  Provide informed consent signed by study participant or legally acceptable&#xD;
             representative&#xD;
&#xD;
        Extension Phase: All randomized patients that complete visit 26, week 96, as long as the&#xD;
        patient 1) provides informed consent and 2) no treatment for DME has been given in the&#xD;
        study eye other than the randomized study treatment.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of macular edema due to any cause other than diabetes mellitus in either eye&#xD;
&#xD;
          -  Active proliferative diabetic retinopathy in the study eye&#xD;
&#xD;
          -  IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab,&#xD;
             pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser&#xD;
             photocoagulation within 12 weeks (84 days) or intraocular or periocular&#xD;
             corticosteroids within 16 weeks (112 days) of the screening visit in the study eye&#xD;
&#xD;
          -  Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific&#xD;
             monoclonal antibodies, gene therapy, etc.) at any time&#xD;
&#xD;
          -  Treatment with ocriplasmin (JETREA®) in the study eye at any time&#xD;
&#xD;
        NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply&#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>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Arcadia</city>
        <state>California</state>
        <zip>91006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Campbell</city>
        <state>California</state>
        <zip>95008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Waterford</city>
        <state>Connecticut</state>
        <zip>06385</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34994</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Oak Forest</city>
        <state>Illinois</state>
        <zip>60452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Southaven</city>
        <state>Mississippi</state>
        <zip>38671</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bloomfield</city>
        <state>New Jersey</state>
        <zip>07003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Liverpool</city>
        <state>New York</state>
        <zip>13088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Oceanside</city>
        <state>New York</state>
        <zip>11572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Shirley</city>
        <state>New York</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Monroeville</city>
        <state>Pennsylvania</state>
        <zip>15146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Beaufort</city>
        <state>South Carolina</state>
        <zip>29902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>West Columbia</city>
        <state>South Carolina</state>
        <zip>29169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Willow Park</city>
        <state>Texas</state>
        <zip>76087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2H 0C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L4W 1W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M3C 0G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1G 2V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Prague 5</city>
        <zip>150 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Praha 10</city>
        <zip>100 34</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Praha 2</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Neubrandenburg</city>
        <state>Mecklenburg-Westfalen</state>
        <zip>17036</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Gottingen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Munster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Pecs</city>
        <state>Baranya</state>
        <zip>H-7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Szombathely</city>
        <state>Vas</state>
        <zip>H-9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Zalaegerszeg</city>
        <state>Zala Megye</state>
        <zip>H-8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Budapest</city>
        <zip>H-1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Budapest</city>
        <zip>H-1106</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Budapest</city>
        <zip>H-1133</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Budapest</city>
        <zip>H-1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Debrecen</city>
        <zip>H-4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Szeged</city>
        <zip>H-6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nagakute</city>
        <state>Aichi</state>
        <zip>480-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>466-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Yoshida-Gun</city>
        <state>Fukui</state>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Koriyama</city>
        <state>Fukushima</state>
        <zip>963-8052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hakodate</city>
        <state>Hokkaido</state>
        <zip>041-0851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mito</city>
        <state>Ibaraki</state>
        <zip>310-0845</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Toride</city>
        <state>Ibaraki</state>
        <zip>302-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tsuchiura-shi</city>
        <state>Ibaraki</state>
        <zip>300-0817</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa</state>
        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>216-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nagasaki City</city>
        <state>Nagasaki</state>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kashihara</city>
        <state>Nara</state>
        <zip>634-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hirakata</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tokorozawa</city>
        <state>Saitama</state>
        <zip>359-8513</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Susono</city>
        <state>Shizuoka</state>
        <zip>410-1102</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chiyoda-ku</city>
        <state>Tokyo</state>
        <zip>101-8309</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <zip>193-0998</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>173-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Meguro-ku</city>
        <state>Tokyo</state>
        <zip>152-8902</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Shimotsuke-shi</city>
        <state>Totigi</state>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>819-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saitama</city>
        <zip>330-8553</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tokushima</city>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Arecibo</city>
        <zip>00612</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sunderland</city>
        <state>Tyne And Wear</state>
        <zip>SR2 9HP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>London</city>
        <zip>EC1V 2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Puerto Rico</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <disposition_first_submitted>May 19, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>May 19, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 24, 2023</disposition_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</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>Macular Edema</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>July 25, 2023</submitted>
    <returned>August 16, 2023</returned>
    <submitted>September 8, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04429503
org study id: VGFTe-HD-DME-1934
secondary id: 2019-003643-30
nct id: NCT04429503
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to determine if treatment with high-dose aflibercept
      (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA)
      compared to aflibercept dosed every 8 weeks.

      The secondary objectives of the study are as follows:

        -  To determine the effect of HD vs. aflibercept on anatomic and other visual measures of
           response

        -  To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in best corrected visual acuity (BCVA)
time frame: At Week 48
measure: Proportion of participants with a ≥2 step improvement in Diabetic Retinopathy Severity Scale (DRSS)
time frame: At Week 48
description: The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.
measure: Change from baseline in best corrected visual acuity (BCVA) (region-specific analysis)
time frame: At Week 60
measure: Proportion of participants gaining ≥15 letters
time frame: At Week 48
measure: Proportion of participants with BCVA ≥69 letters
time frame: At Week 48
measure: Proportion of participants without fluid at foveal center
time frame: At Week 48
measure: Change from baseline in central retinal thickness (CRT)
time frame: At Week 48
measure: Proportion of participants without leakage on fluorescein angiography (FA)
time frame: At Week 48
measure: Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score
time frame: At Week 48
description: Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
measure: Systemic pharmacokinetics (PK) of aflibercept as assessed by plasma concentrations
time frame: Through Week 48
measure: Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response
time frame: Through Week 96
measure: Safety assessed by adverse events (AEs)
time frame: Through Weeks 48, 60, 96 and 156
measure: Safety assessed by serious adverse events (SAEs)
time frame: Through Weeks 48, 60, 96 and 156
measure: Change from baseline in BCVA for participants with both baseline and week 48 BCVA, in the analysis subset
time frame: At Week 48
description: Per SAP Version 2.0 Appendix 10.9 for US Only
measure: Change from 8-weeks post initial treatment phase in BCVA for participants with both 8-weeks post initial treatment phase BCVA and week 48 BCVA, in the analysis subset
time frame: At Week 48
description: Per SAP Version 2.0 Appendix 10.9 for US Only
arm group label: aflibercept Q8
arm group type: Active Comparator
description: Administered every 8 weeks after a loading phase
arm group label: High-Dose aflibercept Q12
arm group type: Experimental
description: Administered every 12 weeks after a loading phase
arm group label: High-Dose aflibercept Q16
arm group type: Experimental
description: Administered every 16 weeks after a loading phase
intervention type: Drug
intervention name: aflibercept
description: Intravitreally (IVT) administered as a liquid formulation in a vial
arm group label: aflibercept Q8
other name: EYLEA®
other name: BAY86-5321
intervention type: Drug
intervention name: High-dose aflibercept
description: Intravitreally (IVT) administered as a liquid formulation in a vial
arm group label: High-Dose aflibercept Q12
arm group label: High-Dose aflibercept Q16
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: Canada
country: Czechia
country: Germany
country: Hungary
country: Japan
country: Puerto Rico
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Diabetes Mellitus, Type 2
mesh term: Aflibercept
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
ipd access criteria: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
ipd url: https://vivli.org/
submitted: July 25, 2023
returned: August 16, 2023
submitted: September 8, 2023