<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/NCT03003416</url>
  </required_header>
  <id_info>
    <org_study_id>GMA-EAME-EYE-0440</org_study_id>
    <nct_id>NCT03003416</nct_id>
  </id_info>
  <brief_title>Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)</brief_title>
  <acronym>Louvre 3</acronym>
  <official_title>Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in&#xD;
      France for the treatment of Diabetic Macular Edema (DME).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2017</start_date>
  <completion_date type="Actual">December 19, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 2018</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>Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale</measure>
    <time_frame>Baseline to Month 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Achieve Maximum Gain in BCVA</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in BCVA</measure>
    <time_frame>Baseline, Week 6, Months 6, 12, 18 and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline</measure>
    <time_frame>Baseline, Week 6, Month 6, 12, 18 and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline</measure>
    <time_frame>Baseline, Week 6, Month 6, 12, 18 and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Retinal Thickness</measure>
    <time_frame>Baseline, Month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline</measure>
    <time_frame>Baseline, Month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness</measure>
    <time_frame>Month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex®</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Categorized by Conditions when Placed on Treatment (Patient Characteristics, Glycosylated Hemoglobin (HbA1c) Level Control, Blood Pressure Control, Prior Treatments, Prior Treatment Failure)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Categorized by Conditions when Use of Ozurdex® (Number of Injections, Number of Follow-up Visits, Criteria for Retreatment and Discontinuation of Treatment)</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg)</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Intra-ocular Pressure (IOP) Changes &gt;10 mmHg from Baseline</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Incident Cataracts</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Cataract Surgeries Related to Treatment or Injection</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Serious Adverse Events</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Death</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">115</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>OZURDEX®</arm_group_label>
    <description>Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone intravitreal implant</intervention_name>
    <description>Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.</description>
    <arm_group_label>OZURDEX®</arm_group_label>
    <other_name>OZURDEX®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with OZURDEX® in clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Patient not residing in metropolitan France.&#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>Nathalie Mesnard</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre MGM</name>
      <address>
        <city>Aix-En-Provence</city>
        <zip>13090</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ballanger</name>
      <address>
        <city>Aulnay-Sous-Bois</city>
        <zip>93600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH BLOIS</name>
      <address>
        <city>Blois</city>
        <zip>41016</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Avicennes Bobigny</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Rétine Gallien à Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Créteil</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH SCORFF - Lorient</name>
      <address>
        <city>Lorient</city>
        <zip>56100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital De La Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Monticelli</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Annecy</name>
      <address>
        <city>Metz-Tessy</city>
        <zip>74370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pasteur 2</name>
      <address>
        <city>Nice</city>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chno 1520</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lariboisiere</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COCHIN</name>
      <address>
        <city>Paris</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Poissy</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de La Milétrie Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Germain en Laye</name>
      <address>
        <city>Saint Germain En Laye</city>
        <zip>78100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre OPHTA.Kervision</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maison Rouge</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</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/NCT03003416
org study id: GMA-EAME-EYE-0440
nct id: NCT03003416
lead sponsor: 
has dmc: No
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in
      France for the treatment of Diabetic Macular Edema (DME).
observational model: Cohort
time perspective: Prospective
measure: Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
time frame: Baseline to Month 24
measure: Time to Achieve Maximum Gain in BCVA
time frame: 24 Months
measure: Change from Baseline in BCVA
time frame: Baseline, Week 6, Months 6, 12, 18 and 24
measure: Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline
time frame: Baseline, Week 6, Month 6, 12, 18 and 24
measure: Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline
time frame: Baseline, Week 6, Month 6, 12, 18 and 24
measure: Change from Baseline in Retinal Thickness
time frame: Baseline, Month 24
measure: Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline
time frame: Baseline, Month 24
measure: Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness
time frame: Month 24
measure: Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex®
time frame: Day 1
measure: Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections
time frame: Day 1
measure: Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes)
time frame: Day 1
measure: Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment)
time frame: Day 1
measure: Percentage of Participants Categorized by Conditions when Placed on Treatment (Patient Characteristics, Glycosylated Hemoglobin (HbA1c) Level Control, Blood Pressure Control, Prior Treatments, Prior Treatment Failure)
time frame: Day 1
measure: Percentage of Participants Categorized by Conditions when Use of Ozurdex® (Number of Injections, Number of Follow-up Visits, Criteria for Retreatment and Discontinuation of Treatment)
time frame: 24 Months
measure: Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity
time frame: 24 Months
measure: Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg)
time frame: 24 Months
measure: Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline
time frame: 24 Months
measure: Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery
time frame: 24 Months
measure: Number of Participants with Incident Cataracts
time frame: 24 Months
measure: Number of Participants with Cataract Surgeries Related to Treatment or Injection
time frame: 24 Months
measure: Percentage of Participants with Serious Adverse Events
time frame: 24 Months
measure: Percentage of Participants with Death
time frame: 24 Months
arm group label: OZURDEX®
description: Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.
intervention type: Drug
intervention name: dexamethasone intravitreal implant
description: Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
arm group label: OZURDEX®
other name: OZURDEX®
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathalie Mesnard
role: Study Director
affiliation: Allergan
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country: France
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Dexamethasone