<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/NCT03797547</url>
  </required_header>
  <id_info>
    <org_study_id>VIC</org_study_id>
    <nct_id>NCT03797547</nct_id>
  </id_info>
  <brief_title>Real Life Study in Myopic Neovascularization</brief_title>
  <acronym>VIC</acronym>
  <official_title>Real Life Study in Myopic Neovascularization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi centre, single arm, prospective observational phase 4 study in naive or&#xD;
      pretreated patients with myopic neovascularization. The patients will be treated with&#xD;
      intravitreal injections of Aflibercept following a real life protocol.&#xD;
&#xD;
      This sudy aims to evaluate the visual acuity during a 36 months period of time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 22, 2018</start_date>
  <completion_date type="Anticipated">January 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>visual acuity measurement</measure>
    <time_frame>6, 12, 24 and 36 months</time_frame>
    <description>Efficacy measurement will be performed by mean change of &quot;ETDRS&quot; for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual acuity measurement in naive patient</measure>
    <time_frame>12, 24 and 36 months</time_frame>
    <description>Efficacy measurement will be performed by mean change of &quot;ETDRS&quot; for Best corrected visual acuity evaluation from baseline to month 12, 24 and 36 after initation of treatment by aflibercept in naïve patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment</measure>
    <time_frame>6, 12, 24 and 36 months</time_frame>
    <description>Efficacy measurement will be evaluated by mean change of &quot;ETDRS&quot; for Best corrected visual Acuity evaluation after initation of treatment by aflibercept after switch from other treatment such as laser, visudyne PDT or other IVT treatment, after 6, 12, 24 and 36 months of treatment with Eylea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pourcentage of patients who gain more than or equal of 15 letters</measure>
    <time_frame>6,12,24 and 36 months</time_frame>
    <description>Efficacy measurement will be evaluated by pourcentage of patients who gain more than or equal of 15 letters at 6, 12, 24 and 36 months after initiation of treatment with aflibercept within naïve or after switch from other treatment such as laser, visudyne PDT or other IVT treatment,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomics parameters by oct</measure>
    <time_frame>6, 12, 24 and 36 months</time_frame>
    <description>Evaluation of anatomic parameters will be perfomed after 6,12, and 24 and 36 months of treatment with Eylea based on OCT parameters :&#xD;
On SD-OCT :&#xD;
Distance from CNV lesion to the fovea measured on the scan joining the fovea to the foveal edge of the mCNV Exudation assessed by presence of intraretinal cysts or subretinal fluid Central retinal thickness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomics parameters by color photographs</measure>
    <time_frame>6, 12, 24 and 36 months</time_frame>
    <description>On color retinal photographs:&#xD;
Presence of retinal hemorrhage Presence of macular atrophy or lacquer cracks,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomic parameters by fluoresceine angiography or angiography oct</measure>
    <time_frame>6, 12, 24 and 36 months</time_frame>
    <description>On fluoresceine angiography if deemed necessary by the investigator : diffusion during late phases On angiography OCT : neovascular network visualisation</description>
  </secondary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Myopic Choroidal Neovascularisation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AFLIBERCEPT</intervention_name>
    <description>Patients will be treated following a real life protocol and according to the French recommendation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Active mCNV among:&#xD;
&#xD;
          -  Naïve patients.&#xD;
&#xD;
          -  Patients with previous history of laser photocoagulation or PDT, with no history of&#xD;
             anti-VEGF.&#xD;
&#xD;
          -  Patients with previous history of other anti-VEGF treatments.including ranibizumab or&#xD;
             bevacizumab, with sustaining mCNV activity, who did not receive injection since the&#xD;
             last 3 month&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman aged 18 years and more under reliable method of contraception for woman&#xD;
             with childbearing potenteial (hormonal or any intrauterine devices).&#xD;
&#xD;
          -  High myopy defined by refractive error ≤ -6 D or History of high myopia among&#xD;
             pseudophakic patient or patient treated with refractive surgery&#xD;
&#xD;
          -  Patient with active CNVm&#xD;
&#xD;
          -  • Patients naïve or Patients pretreated with previous history of laser&#xD;
             photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection&#xD;
             since the last 3 month&#xD;
&#xD;
               -  with OCT or angiography examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with an anti VEGF administrated by intravitreal injection within 1 months&#xD;
             prior to baseline in the study eye.&#xD;
&#xD;
          -  Treatment with PDT or laser administrated within 6 months prior to baseline in the&#xD;
             study eye.&#xD;
&#xD;
          -  History of vitrectomy in the study eye&#xD;
&#xD;
          -  History of any other retinal disease&#xD;
&#xD;
          -  VA less than 20/250&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</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>Choroidal Neovascularization</mesh_term>
    <mesh_term>Myopia</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/NCT03797547
org study id: VIC
nct id: NCT03797547
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a multi centre, single arm, prospective observational phase 4 study in naive or
      pretreated patients with myopic neovascularization. The patients will be treated with
      intravitreal injections of Aflibercept following a real life protocol.

      This sudy aims to evaluate the visual acuity during a 36 months period of time.
observational model: Cohort
time perspective: Prospective
measure: visual acuity measurement
time frame: 6, 12, 24 and 36 months
description: Efficacy measurement will be performed by mean change of "ETDRS" for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept
measure: visual acuity measurement in naive patient
time frame: 12, 24 and 36 months
description: Efficacy measurement will be performed by mean change of "ETDRS" for Best corrected visual acuity evaluation from baseline to month 12, 24 and 36 after initation of treatment by aflibercept in naïve patients
measure: visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment
time frame: 6, 12, 24 and 36 months
description: Efficacy measurement will be evaluated by mean change of "ETDRS" for Best corrected visual Acuity evaluation after initation of treatment by aflibercept after switch from other treatment such as laser, visudyne PDT or other IVT treatment, after 6, 12, 24 and 36 months of treatment with Eylea
measure: pourcentage of patients who gain more than or equal of 15 letters
time frame: 6,12,24 and 36 months
description: Efficacy measurement will be evaluated by pourcentage of patients who gain more than or equal of 15 letters at 6, 12, 24 and 36 months after initiation of treatment with aflibercept within naïve or after switch from other treatment such as laser, visudyne PDT or other IVT treatment,
measure: Anatomics parameters by oct
time frame: 6, 12, 24 and 36 months
description: Evaluation of anatomic parameters will be perfomed after 6,12, and 24 and 36 months of treatment with Eylea based on OCT parameters :
On SD-OCT :
Distance from CNV lesion to the fovea measured on the scan joining the fovea to the foveal edge of the mCNV Exudation assessed by presence of intraretinal cysts or subretinal fluid Central retinal thickness
measure: Anatomics parameters by color photographs
time frame: 6, 12, 24 and 36 months
description: On color retinal photographs:
Presence of retinal hemorrhage Presence of macular atrophy or lacquer cracks,
measure: Anatomic parameters by fluoresceine angiography or angiography oct
time frame: 6, 12, 24 and 36 months
description: On fluoresceine angiography if deemed necessary by the investigator : diffusion during late phases On angiography OCT : neovascular network visualisation
intervention type: Other
intervention name: AFLIBERCEPT
description: Patients will be treated following a real life protocol and according to the French recommendation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Choroidal Neovascularization
mesh term: Myopia
mesh term: Neovascularization, Pathologic
mesh term: Aflibercept