<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/NCT03783832</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A03478-45</org_study_id>
    <nct_id>NCT03783832</nct_id>
  </id_info>
  <brief_title>Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography</brief_title>
  <acronym>DOCTA</acronym>
  <official_title>Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aquitania Opthalmologica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aquitania Opthalmologica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 non-interventional, longitudinal, retrospective and prospective, non-controlled,&#xD;
      single arm study in naive or non-naive patients with diabetic macular edema for which&#xD;
      aflibercept (EYLEA®) therapy is indicated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quantitative data from OCT angiography</measure>
    <time_frame>1 Year</time_frame>
    <description>The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative data from OCT angiography</measure>
    <time_frame>1 Year</time_frame>
    <description>The perfusion density assessment (%) measured by OCT angiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative data from OCT angiography</measure>
    <time_frame>1 Year</time_frame>
    <description>The vascular density assessment (%) measured by OCT angiography</description>
  </primary_outcome>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OCT ANGIOGRAPHY DATA</intervention_name>
    <description>Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Diabetic Macular Edema&#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 potential (hormonal or any intrauterine devices).&#xD;
&#xD;
          -  Patients with type I or II diabetes (as defined by criteria of American diabetes&#xD;
             association ADA or world health organization WHO) with an glycosylated hemoglobin rate&#xD;
             (HbA1c) &lt; 10.0%, at initial visit (First EYLEA® injection).&#xD;
&#xD;
          -  Patients with diabetes treatment unchanged within the last 3 months prior to initial&#xD;
             visit (First EYLEA® injection).&#xD;
&#xD;
          -  Patients showing a visual lost due to a diabetic macular edema (DME) in the central&#xD;
             region and not for another reason, assessed by the investigateur. The visual acuity of&#xD;
             the fellow eye is not an exclusion criteria.&#xD;
&#xD;
          -  Patient to whom a treatment by aflibercept is indicated and OCT-angiography is&#xD;
             performed at each injection visit.&#xD;
&#xD;
          -  Patients affiliated to social security system.&#xD;
&#xD;
          -  Patient who has been given appropriate information about the study objectives and&#xD;
             instructions who has given his/her non-opposition prior to conduct any study-related&#xD;
             procedures and examination.&#xD;
&#xD;
        Non iclusion Criteria:&#xD;
&#xD;
          -  Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by&#xD;
             intravitreal injection within 3 months prior to initial visit in the study eye&#xD;
&#xD;
          -  Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior&#xD;
             to initial visit (First EYLEA® injection) in the study eye&#xD;
&#xD;
          -  History of or active ocular /intraocular inflammation (Uveitis) at initial visit&#xD;
             (First EYLEA® injection), in either eye&#xD;
&#xD;
          -  Intra-ocular pressure ≥ 25 mmHg&#xD;
&#xD;
          -  Patient with neocascular glaucoma history&#xD;
&#xD;
          -  Patient with foveolar exsudat that interfere with images analysis.&#xD;
&#xD;
          -  History or current evidence of hypersentivity to mydriatic eye drops&#xD;
&#xD;
          -  Vitreomacular traction in the study eye&#xD;
&#xD;
          -  Panretinal coagulation within 3 months prior to initial visit (First EYLEA®&#xD;
             injection), in the study eye.&#xD;
&#xD;
          -  Cataract surgery in the study eye within the 6 months prior to initial visit (First&#xD;
             EYLEA® injection)&#xD;
&#xD;
          -  History of vitretectomy in the study eye&#xD;
&#xD;
          -  Treatment with systemic anti VEGF medications for cancer&#xD;
&#xD;
          -  History of cerebrovascular accident within 3 months prior to initial visit (First&#xD;
             EYLEA® injection), renal failure, uncontrolled arterial hypertension (PAS&gt;160 mm Hg&#xD;
             and/ or PAD&gt;100 mm Hg)&#xD;
&#xD;
          -  Patient who does not meet the local indication criteria for Eylea® treatment.&#xD;
             Contraindications listed in the SmPCs must be taken into account&#xD;
&#xD;
          -  Participation in any investigational study with exclusion period in progress at the&#xD;
             initial visit (First EYLEA® injection)&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  Pregnant or breastfeeding woman.&#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_contact>
    <last_name>KOROBELNIK</last_name>
    <phone>33 5 57 82 12 16</phone>
    <email>jean-francois.korobelnik@chu-bordeaux.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-François KOROBELNIK</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine CREUZOT-GARCHER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent KODJIKIAN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel WEBER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nice</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphanie BAILLIF</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David GAUCHER</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</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>Edema</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/NCT03783832
org study id: 2017-A03478-45
nct id: NCT03783832
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-interventional, longitudinal, retrospective and prospective, non-controlled,
      single arm study in naive or non-naive patients with diabetic macular edema for which
      aflibercept (EYLEA®) therapy is indicated.
observational model: Cohort
time perspective: Other
measure: Quantitative data from OCT angiography
time frame: 1 Year
description: The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography
measure: Quantitative data from OCT angiography
time frame: 1 Year
description: The perfusion density assessment (%) measured by OCT angiography
measure: Quantitative data from OCT angiography
time frame: 1 Year
description: The vascular density assessment (%) measured by OCT angiography
intervention type: Other
intervention name: OCT ANGIOGRAPHY DATA
description: Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: KOROBELNIK
phone: 33 5 57 82 12 16
email: jean-francois.korobelnik@chu-bordeaux.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema