<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/NCT02246829</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/18</org_study_id>
    <nct_id>NCT02246829</nct_id>
  </id_info>
  <brief_title>Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®)START</brief_title>
  <acronym>START</acronym>
  <official_title>Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for&#xD;
      patients suffering from neovascular age-related-macular degeneration.1 This early dramatic&#xD;
      reduction in CRT is already observed through week 4. Therefore it might be not necessary to&#xD;
      consistently perform each of the three monthly consecutive intravitreal injections of the&#xD;
      so-called loading phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess whether the retina of some patients has dried up after the&#xD;
      first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to&#xD;
      determine the proportion of these patients The analysis of the characteristics could help&#xD;
      identify a morphotype that would predict whether and when the retina will dry up within the&#xD;
      first 3 months of treatment. For some patients having an early drying-up, the third monthly&#xD;
      injection might be not necessary 50 naïve patients will be included and will receive a&#xD;
      monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional&#xD;
      characteristics will be recorded at each visit and will be analyzed. The rate of patients&#xD;
      with dry SD-OCT will be assessed.&#xD;
&#xD;
      The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline&#xD;
      to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®)&#xD;
      2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or&#xD;
      Fluorescein Angiography are performed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg</measure>
    <time_frame>12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to get a dry SD-OCT after initiation of a treatment by Aflibercept</measure>
    <time_frame>Every 2 weeks from treatment initiation (inclusion) to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of morphological and visual modification under Aflibercept (EYLEA®)</measure>
    <time_frame>Every 2 weeks from treatment initiation (inclusion) to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of pigment epithelial detachment</measure>
    <time_frame>Every 2 weeks from treatment initiation (inclusion) to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of retinal hemorrhage if any</measure>
    <time_frame>Every 2 weeks from treatment initiation (inclusion) to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution in the atrophic lesions</measure>
    <time_frame>Every 2 weeks from treatment initiation (inclusion) to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence the central Retinal Thickness</measure>
    <time_frame>Every 2 weeks from treatment initiation (inclusion) to week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Neovascular Age-related Macular Degeneration of All Subtypes</condition>
  <arm_group>
    <arm_group_label>Aflibercept 2mg Intravitreal injection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intravitreal injection</intervention_name>
    <description>2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period</description>
    <arm_group_label>Aflibercept 2mg Intravitreal injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ≥ 50 years of age&#xD;
&#xD;
          -  Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD&#xD;
             including juxtafoveal lesions that affects the fovea as evidenced by FA in the study&#xD;
             eye&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
          -  Willing, committed, and able to return for ALL clinic visits and complete all&#xD;
             study-related procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with anti-VEGF therapy in the study eye&#xD;
&#xD;
          -  Active or suspected ocular or periocular infection.&#xD;
&#xD;
          -  Active severe intraocular inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-François KOROBELNIK, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bordeaux, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geneviève CHENE, MDPhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Bordeaux, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'Ophtalmologie Hôpital de la croix rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve</name>
      <address>
        <city>Montargis</city>
        <zip>45200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle</name>
      <address>
        <city>Paris</city>
        <zip>75011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard</name>
      <address>
        <city>Rouen</city>
        <zip>76100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Ophtalmologie Transparence 30 Boulevard Heurteloup</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.</citation>
    <PMID>23558214</PMID>
  </reference>
  <reference>
    <citation>Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006.</citation>
    <PMID>18088159</PMID>
  </reference>
  <reference>
    <citation>Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.</citation>
    <PMID>17021318</PMID>
  </reference>
  <reference>
    <citation>Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.</citation>
    <PMID>21057805</PMID>
  </reference>
  <reference>
    <citation>Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020. Erratum In: Ophthalmology. 2011 Sep;118(9):1700.</citation>
    <PMID>21640258</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wet AMD, SD-OCT, intravitreal injection, central retinal thickness,</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/NCT02246829
org study id: CHUBX 2013/18
nct id: NCT02246829
lead sponsor: 
has dmc: No
Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for
      patients suffering from neovascular age-related-macular degeneration.1 This early dramatic
      reduction in CRT is already observed through week 4. Therefore it might be not necessary to
      consistently perform each of the three monthly consecutive intravitreal injections of the
      so-called loading phase.
The aim of this study is to assess whether the retina of some patients has dried up after the
      first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to
      determine the proportion of these patients The analysis of the characteristics could help
      identify a morphotype that would predict whether and when the retina will dry up within the
      first 3 months of treatment. For some patients having an early drying-up, the third monthly
      injection might be not necessary 50 naïve patients will be included and will receive a
      monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional
      characteristics will be recorded at each visit and will be analyzed. The rate of patients
      with dry SD-OCT will be assessed.

      The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline
      to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®)
      2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or
      Fluorescein Angiography are performed
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
time frame: 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
measure: Time to get a dry SD-OCT after initiation of a treatment by Aflibercept
time frame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Evolution of morphological and visual modification under Aflibercept (EYLEA®)
time frame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Occurence of pigment epithelial detachment
time frame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Evolution of retinal hemorrhage if any
time frame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Evolution in the atrophic lesions
time frame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Occurence the central Retinal Thickness
time frame: Every 2 weeks from treatment initiation (inclusion) to week 12
arm group label: Aflibercept 2mg Intravitreal injection
arm group type: Other
description: 2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period
intervention type: Procedure
intervention name: Intravitreal injection
description: 2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period
arm group label: Aflibercept 2mg Intravitreal injection
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-François KOROBELNIK, Professor
role: Principal Investigator
affiliation: University Hospital Bordeaux, France
last name: Geneviève CHENE, MDPhD
role: Study Chair
affiliation: University Hospital Bordeaux, France
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.
PMID: 23558214
citation: Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006.
PMID: 18088159
citation: Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
PMID: 17021318
citation: Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.
PMID: 21057805
citation: Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020. Erratum In: Ophthalmology. 2011 Sep;118(9):1700.
PMID: 21640258
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration