<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/NCT01660802</url>
  </required_header>
  <id_info>
    <org_study_id>206207-020</org_study_id>
    <nct_id>NCT01660802</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)</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 study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug&#xD;
      Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month&#xD;
      double-blind period versus sham followed by a 2 month open label period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2012</start_date>
  <completion_date type="Actual">May 20, 2014</completion_date>
  <primary_completion_date type="Actual">March 31, 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Change From Baseline in BCVA in the Study Eye</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in BCVA in the Study Eye</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6</time_frame>
    <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6</time_frame>
    <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Macular Edema</condition>
  <arm_group>
    <arm_group_label>700 μg Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham administered in the study eye on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>700 μg Dexamethasone</intervention_name>
    <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
    <arm_group_label>700 μg Dexamethasone</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
    <other_name>Ozurdex®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>Sham administered in the study eye on Day 1.</description>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Presence of macular edema defined as macular thickening involving the center of the macula&#xD;
        due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of glaucoma, ocular hypertension or optic nerve head change&#xD;
&#xD;
          -  Any active bacterial, viral, parasitic, or fungal infections in either eye&#xD;
&#xD;
          -  Eye surgery, including cataract surgery, and/or laser of any type in the study eye&#xD;
             within 3 months prior to study start&#xD;
&#xD;
          -  History of use of intravitreal steroids or any intravitreal injectable drug in the&#xD;
             study eye within 3 months prior to study start&#xD;
&#xD;
          -  Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal&#xD;
             steroids within 1 month prior to study start&#xD;
&#xD;
          -  Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents&#xD;
             within 3 months prior to study start&#xD;
&#xD;
          -  Use of topical ophthalmic corticosticosteroids within 2 weeks of study start&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</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>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.</citation>
    <PMID>29119239</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>April 2, 2015</results_first_submitted>
  <results_first_submitted_qc>May 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 8, 2015</results_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>700 μg Dexamethasone</title>
          <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Sham</title>
          <description>Sham administered in the study eye on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>700 μg Dexamethasone</title>
          <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Sham</title>
          <description>Sham administered in the study eye on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
            <count group_id="B2" value="132"/>
            <count group_id="B3" value="262"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;45 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 to 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye</title>
        <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>Modified Intent-to-Treat: all randomized and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>700 μg Dexamethasone</title>
            <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham administered in the study eye on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye</title>
          <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.</description>
          <population>Modified Intent-to-Treat: all randomized and treated patients</population>
          <units>Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Change From Baseline in BCVA in the Study Eye</title>
        <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>Modified Intent-to-Treat: all randomized and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>700 μg Dexamethasone</title>
            <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham administered in the study eye on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Change From Baseline in BCVA in the Study Eye</title>
          <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.</description>
          <population>Modified Intent-to-Treat: all randomized and treated patients</population>
          <units>Letters Read Correctly</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6" spread="10.79"/>
                    <measurement group_id="O2" value="53.1" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Change from Baseline Over 6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="8.98"/>
                    <measurement group_id="O2" value="2.5" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in BCVA in the Study Eye</title>
        <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.</description>
        <time_frame>Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6</time_frame>
        <population>Modified Intent-to-Treat: all randomized and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>700 μg Dexamethasone</title>
            <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham administered in the study eye on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BCVA in the Study Eye</title>
          <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.</description>
          <population>Modified Intent-to-Treat: all randomized and treated patients</population>
          <units>Letters Read Correctly</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6" spread="10.79"/>
                    <measurement group_id="O2" value="53.1" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="8.45"/>
                    <measurement group_id="O2" value="2.0" spread="9.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="10.36"/>
                    <measurement group_id="O2" value="1.7" spread="12.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="12.66"/>
                    <measurement group_id="O2" value="1.8" spread="12.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="12.79"/>
                    <measurement group_id="O2" value="3.3" spread="12.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="13.28"/>
                    <measurement group_id="O2" value="3.3" spread="13.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="15.34"/>
                    <measurement group_id="O2" value="4.0" spread="13.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye</title>
        <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.</description>
        <time_frame>Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6</time_frame>
        <population>Modified Intent-to-Treat: all randomized and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>700 μg Dexamethasone</title>
            <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham administered in the study eye on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye</title>
          <description>BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.</description>
          <population>Modified Intent-to-Treat: all randomized and treated patients</population>
          <units>Percentage of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7"/>
                    <measurement group_id="O2" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3"/>
                    <measurement group_id="O2" value="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5"/>
                    <measurement group_id="O2" value="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3"/>
                    <measurement group_id="O2" value="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>700 μg Dexamethasone</title>
          <description>700 μg Dexamethasone intravitreal injection in the study eye on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Sham</title>
          <description>Sham administered in the study eye on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vitreous Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Conjunctival Hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for at least 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head,</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01660802
org study id: 206207-020
nct id: NCT01660802
lead sponsor: 
has dmc: No
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug
      Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month
      double-blind period versus sham followed by a 2 month open label period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
time frame: Baseline, 6 Months
description: BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
measure: Average Change From Baseline in BCVA in the Study Eye
time frame: Baseline, 6 Months
description: BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
measure: Change From Baseline in BCVA in the Study Eye
time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
description: BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.
measure: Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
description: BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
arm group label: 700 μg Dexamethasone
arm group type: Experimental
description: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
arm group label: Sham
arm group type: Sham Comparator
description: Sham administered in the study eye on Day 1.
intervention type: Drug
intervention name: 700 μg Dexamethasone
description: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
arm group label: 700 μg Dexamethasone
arm group label: Sham
other name: Ozurdex®
intervention type: Other
intervention name: Sham
description: Sham administered in the study eye on Day 1.
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: China
citation: Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.
PMID: 29119239
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Dexamethasone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 