<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/NCT02257502</url>
  </required_header>
  <id_info>
    <org_study_id>2013.839</org_study_id>
    <secondary_id>2013-005081-19</secondary_id>
    <nct_id>NCT02257502</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients</brief_title>
  <acronym>INTUITION</acronym>
  <official_title>Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Iodiopathic Choroidal Neovascularization in Young Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (&lt;50&#xD;
      years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown.&#xD;
      This is a rare and severe disease, which can lead to blindness.&#xD;
&#xD;
      ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)&#xD;
      therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated&#xD;
      in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not&#xD;
      need as many injections as in AMD.&#xD;
&#xD;
      INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main&#xD;
      objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment&#xD;
      with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen&#xD;
      is designed to achieve maximum efficiency. The patients are followed on a monthly basis until&#xD;
      52 weeks. Intravitreal injections of aflibercept are initiated with a Treat &amp; Extend (TAE)&#xD;
      regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV&#xD;
      activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in&#xD;
      case of CNV activity).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2015</start_date>
  <completion_date type="Actual">July 11, 2019</completion_date>
  <primary_completion_date type="Actual">July 11, 2019</primary_completion_date>
  <phase>Phase 2</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>Mean change in best-corrected visual acuity (BCVA) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
    <description>BCVA is measured on the ETDRS scale at an initial distance of 4 meters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with a &lt;15-letter loss in BCVA measured with ETDRS scale from baseline to week 24</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with a &lt;15-letter loss in BCVA measured with ETDRS scale from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of injections per patient during the TAE regimen (until week 20)</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20)</measure>
    <time_frame>32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total number of injections per patient during the study</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in CRT in micrometers measured with SD-OCT from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in neovascular lesion size and morphology measured with fluorescein and/or indocyanin green angiography from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side-effects observed during the study</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Idiopathic Choroidal Neovascularization</condition>
  <arm_group>
    <arm_group_label>aflibercept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravitreal injection of aflibercept (EYLEA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aflibercept</intervention_name>
    <description>The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated with a TAE regimen until 20 weeks (3 mandatory injections at inclusion, week 8 and 20 with reinjection at week 4, 12 and 16 only in case of CNV activity). Then, a PRN regimen is considered until 52 weeks (reinjection in case of CNV activity). Therefore, each patient receives between 3 and 13 injections in the whole study.</description>
    <arm_group_label>aflibercept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 &lt; Age &lt; 50 years old&#xD;
&#xD;
          -  Patient who give voluntary signed informed consent&#xD;
&#xD;
          -  Patient affiliated with the French universal health care system or similar&#xD;
&#xD;
          -  Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions&#xD;
             that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin&#xD;
             green) and/or SD-OCT in the studied eye&#xD;
&#xD;
          -  Patient willing, committed and able to return for all clinic visits and complete all&#xD;
             study-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Sexually active men or women of childbearing potential who are unwilling to practice&#xD;
             adequate contraception during the study&#xD;
&#xD;
          -  Patient who is protected adults according to the terms of the law (French public&#xD;
             health laws)&#xD;
&#xD;
          -  Involvement in another clinical trial (studied eye and/or the other eye)&#xD;
&#xD;
          -  Patient with non-ICNV, especially:&#xD;
&#xD;
               -  AMD&#xD;
&#xD;
               -  High myopia defined as refraction ≥ - 6 diopters&#xD;
&#xD;
          -  Other curative treatment of ICNV in the studied eye during the last 3 months before&#xD;
             the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular&#xD;
             laser, photodynamic therapy, surgery, external radiotherapy, transpupillary&#xD;
             thermotherapy ...&#xD;
&#xD;
          -  Medical history of retrofoveal focal macular laser photocoagulation in the studied eye&#xD;
&#xD;
          -  Subretinal haemorrhage reaching the fovea centre, with a size &gt; 50% of the lesion area&#xD;
&#xD;
          -  Fibrosis or retrofoveal retinal atrophy in the studied eye&#xD;
&#xD;
          -  Retinal pigment epithelial tear reaching the macula in the studied eye&#xD;
&#xD;
          -  Medical history of intravitreal medical device in the studied eye&#xD;
&#xD;
          -  Medical history of auto-immune or idiopathic uveitis&#xD;
&#xD;
          -  Proved diabetic retinopathy&#xD;
&#xD;
          -  Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments&#xD;
&#xD;
          -  Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye&#xD;
&#xD;
          -  Arterial hypertension that is not controlled by an appropriate treatment&#xD;
&#xD;
          -  Previous or actual treatment with systemic administration of anti-VEGF therapy&#xD;
&#xD;
          -  Known hypersensitivity to aflibercept, or another drug composite of the medicinal&#xD;
             product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops&#xD;
&#xD;
          -  Active or suspected ocular or peri-ocular infection&#xD;
&#xD;
          -  Serious active intra-ocular inflammation in the studied eye&#xD;
&#xD;
          -  Medical history of intra-ocular surgery within 28 days before the first injection in&#xD;
             the studied eye&#xD;
&#xD;
          -  Any illness or ocular condition that would require an intra-ocular surgery in the&#xD;
             studied eye within 12 months after the inclusion&#xD;
&#xD;
          -  Follow up not possible during 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurent KODJIKIAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Hôpital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aflibercept</keyword>
  <keyword>iodiopathic choroidal neovascularization</keyword>
  <keyword>young patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT02257502
org study id: 2013.839
secondary id: 2013-005081-19
nct id: NCT02257502
lead sponsor: 
has dmc: No
After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50
      years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown.
      This is a rare and severe disease, which can lead to blindness.

      ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)
      therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated
      in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not
      need as many injections as in AMD.

      INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main
      objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment
      with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen
      is designed to achieve maximum efficiency. The patients are followed on a monthly basis until
      52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE)
      regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV
      activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in
      case of CNV activity).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change in best-corrected visual acuity (BCVA) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52
time frame: 52 weeks
description: BCVA is measured on the ETDRS scale at an initial distance of 4 meters
measure: Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
time frame: 24 weeks
measure: Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24
time frame: 24 weeks
measure: Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52
time frame: 52 weeks
measure: Mean number of injections per patient during the TAE regimen (until week 20)
time frame: 20 weeks
measure: Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20)
time frame: 32 weeks
measure: Mean total number of injections per patient during the study
time frame: 52 weeks
measure: Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24
time frame: 24 weeks
measure: Mean change in CRT in micrometers measured with SD-OCT from baseline to week 52
time frame: 52 weeks
measure: Mean change in neovascular lesion size and morphology measured with fluorescein and/or indocyanin green angiography from baseline to week 52
time frame: 52 weeks
measure: Side-effects observed during the study
time frame: 52 weeks
arm group label: aflibercept
arm group type: Experimental
description: intravitreal injection of aflibercept (EYLEA)
intervention type: Drug
intervention name: aflibercept
description: The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated with a TAE regimen until 20 weeks (3 mandatory injections at inclusion, week 8 and 20 with reinjection at week 4, 12 and 16 only in case of CNV activity). Then, a PRN regimen is considered until 52 weeks (reinjection in case of CNV activity). Therefore, each patient receives between 3 and 13 injections in the whole study.
arm group label: aflibercept
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Laurent KODJIKIAN
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Choroidal Neovascularization
mesh term: Neovascularization, Pathologic
mesh term: Aflibercept