<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/NCT02188173</url>
  </required_header>
  <id_info>
    <org_study_id>GMA-US-EYE-0272</org_study_id>
    <secondary_id>REINFORCE</secondary_id>
    <nct_id>NCT02188173</nct_id>
  </id_info>
  <brief_title>An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)</brief_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 is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema&#xD;
      (DME).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Change from Baseline in BCVA in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients with BCVA of 20/40 or Better in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Ozurdex Injections in the Study Eye</measure>
    <time_frame>12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time Between Ozurdex Injections in the Study Eye</measure>
    <time_frame>12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye</measure>
    <time_frame>Baseline, 12 Months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Macular Edema</condition>
  <arm_group>
    <arm_group_label>dexamethasone 700 ㎍ intravitreal implant</arm_group_label>
    <description>Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone 700 ㎍ intravitreal implant</intervention_name>
    <description>Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.</description>
    <arm_group_label>dexamethasone 700 ㎍ intravitreal implant</arm_group_label>
    <other_name>OZURDEX®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retinal Consultants of Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Coast Retina</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange Co Retina Medical Group</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Retina Associates</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Retina Associates</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Retina Associates</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raj Maturi, MD PC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John-Kenyon American Eye Institute</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Retina Consultants</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Retinal Consultants, PC</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>69686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifelong Vision Foundation</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eyesight Ophthalmic Services</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Retina</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Retina</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates, Arlington</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Retina Institute, P.A.</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Ophthalmology Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>May 31, 2016</last_update_submitted>
  <last_update_submitted_qc>May 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 1, 2016</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/NCT02188173
org study id: GMA-US-EYE-0272
secondary id: REINFORCE
nct id: NCT02188173
lead sponsor: 
has dmc: No
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema
      (DME).
observational model: Cohort
time perspective: Prospective
measure: Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
time frame: Baseline, 12 Months
measure: Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye
time frame: Baseline, 12 Months
measure: Average Change from Baseline in BCVA in the Study Eye
time frame: Baseline, 12 Months
measure: Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye
time frame: Baseline, 12 Months
measure: Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye
time frame: Baseline, 12 Months
measure: Percentage of Patients with BCVA of 20/40 or Better in the Study Eye
time frame: Baseline, 12 Months
measure: Mean Number of Ozurdex Injections in the Study Eye
time frame: 12 Months
measure: Mean Time Between Ozurdex Injections in the Study Eye
time frame: 12 Months
measure: Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye
time frame: Baseline, 12 Months
arm group label: dexamethasone 700 ㎍ intravitreal implant
description: Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.
intervention type: Drug
intervention name: dexamethasone 700 ㎍ intravitreal implant
description: Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.
arm group label: dexamethasone 700 ㎍ intravitreal implant
other name: OZURDEX®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Dexamethasone