<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/NCT01673191</url>
  </required_header>
  <id_info>
    <org_study_id>RCA2012</org_study_id>
    <nct_id>NCT01673191</nct_id>
  </id_info>
  <brief_title>A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus</brief_title>
  <official_title>A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Retinal Consultants of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Retinal Consultants of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a need to find an effective therapy for diabetic patients who develop macular edema&#xD;
      after cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular&#xD;
      implant in patients with diabetes mellitus, who develop macular edema after cataract surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Best Corrected Visual Acuity</measure>
    <time_frame>1 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Best Corrected Visual Acuity</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Best Corrected Visual Acuity</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Central Retinal Thickness</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Central Retinal Thickness</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Central Retinal Thickness</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Intraocular Pressure</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Macular Edema</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>OZURDEX intraocular implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Steroid plus NSAID eye drop combination therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NSAID eye drop: Acular LS Steriod eye drop: Pred Forte</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone intravitreal implant</intervention_name>
    <arm_group_label>OZURDEX intraocular implant</arm_group_label>
    <other_name>OZURDEX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Steroid plus NSAID eye drop combination therapy</intervention_name>
    <arm_group_label>Steroid plus NSAID eye drop combination therapy</arm_group_label>
    <other_name>Acular LS and Pred Forte</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has diagnosis of Diabetes Mellitus, Type I or II.&#xD;
&#xD;
          -  Patient has experienced the development of macular edema following cataract surgery in&#xD;
             at least one eye.&#xD;
&#xD;
          -  Patient has had cataract surgery within 90 days prior to the screening visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has other significant ocular disease in study eye, including glaucoma.&#xD;
&#xD;
          -  Patient has any active infection in the study eye.&#xD;
&#xD;
          -  Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure,&#xD;
             uncontrolled diabetes mellitus).&#xD;
&#xD;
          -  Patient has experienced a significant increase in intraocular pressure following a&#xD;
             prior treatment with topical or intravitreal steroidal medication.&#xD;
&#xD;
          -  Patient has received the OZURDEX® implant before in the study eye.&#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>Pravin U Dugel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Retinal Consultants of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retinal Consultants of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>February 20, 2017</results_first_submitted>
  <results_first_submitted_qc>February 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 5, 2017</results_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</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>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OZURDEX Intraocular Implant</title>
          <description>OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg&#xD;
Dexamethasone intravitreal implant</description>
        </group>
        <group group_id="P2">
          <title>Steroid Plus NSAID Eye Drop Combination Therapy</title>
          <description>NSAID eye drop: Acular LS Steriod eye drop: Pred Forte&#xD;
Steroid plus NSAID eye drop combination therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DEX IMPLANT ARM</title>
          <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
        </group>
        <group group_id="B2">
          <title>Topical Steroid/NSAID ARM</title>
          <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</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="26"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.1" spread="7.6"/>
                    <measurement group_id="B2" value="68" spread="8.4"/>
                    <measurement group_id="B3" value="67.4" spread="7.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Best Corrected Visual Acuity</title>
          <description>logMAR</description>
          <units>logMAR units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.49" spread="0.40"/>
                    <measurement group_id="B2" value="0.32" spread="0.22"/>
                    <measurement group_id="B3" value="0.44" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Central Retinal Thickness</title>
          <description>Based on spectral domain optical coherence tomography (SD-OCT)</description>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="402.2" spread="149.8"/>
                    <measurement group_id="B2" value="403.5" spread="156.2"/>
                    <measurement group_id="B3" value="402.5" spread="149.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intraocular Pressure</title>
          <units>millimeters of mercury (mm Hg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.7" spread="2.8"/>
                    <measurement group_id="B2" value="14.4" spread="2.5"/>
                    <measurement group_id="B3" value="13.9" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Best Corrected Visual Acuity</title>
        <time_frame>1 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Best Corrected Visual Acuity</title>
          <units>logMAR units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.2"/>
                    <measurement group_id="O2" value="0.33" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Best Corrected Visual Acuity</title>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Best Corrected Visual Acuity</title>
          <units>logMAR units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.46"/>
                    <measurement group_id="O2" value="0.22" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Best Corrected Visual Acuity</title>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Best Corrected Visual Acuity</title>
          <units>logMAR units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.45"/>
                    <measurement group_id="O2" value="0.21" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Central Retinal Thickness</title>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Central Retinal Thickness</title>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286.9" spread="66.1"/>
                    <measurement group_id="O2" value="360.8" spread="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Central Retinal Thickness</title>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Central Retinal Thickness</title>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="270.42" spread="46.8"/>
                    <measurement group_id="O2" value="336" spread="75.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Central Retinal Thickness</title>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Central Retinal Thickness</title>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318.7" spread="103.2"/>
                    <measurement group_id="O2" value="341.1" spread="74.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Intraocular Pressure</title>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX IMPLANT ARM</title>
            <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
          </group>
          <group group_id="O2">
            <title>Topical Steroid/NSAID ARM</title>
            <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Intraocular Pressure</title>
          <units>millimeters of mercury (mm Hg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="3.3"/>
                    <measurement group_id="O2" value="14.1" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DEX IMPLANT ARM</title>
          <description>Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP &lt;28 mmHg.</description>
        </group>
        <group group_id="E2">
          <title>Topical Steroid/NSAID ARM</title>
          <description>Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated Intraocular Pressure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations of our study include a small sample size and short-term follow up. Additional studies are needed to determine whether combination therapy with other treatments would be beneficial to patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Pravin Dugel</name_or_title>
      <organization>Retinal Consultants of Arizona</organization>
      <phone>602-222-2221</phone>
      <email>PDugel@gmail.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/NCT01673191
org study id: RCA2012
nct id: NCT01673191
lead sponsor: 
collaborator: 
has dmc: No
There is a need to find an effective therapy for diabetic patients who develop macular edema
      after cataract surgery.
The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular
      implant in patients with diabetes mellitus, who develop macular edema after cataract surgery
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change in Best Corrected Visual Acuity
time frame: 1 months
measure: Mean Change in Best Corrected Visual Acuity
time frame: 2 months
measure: Mean Change in Best Corrected Visual Acuity
time frame: 3 months
measure: Mean Change in Central Retinal Thickness
time frame: 1 month
measure: Mean Change in Central Retinal Thickness
time frame: 2 months
measure: Mean Change in Central Retinal Thickness
time frame: 3 months
measure: Mean Change in Intraocular Pressure
time frame: 3 months
arm group label: OZURDEX intraocular implant
arm group type: Experimental
description: OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
arm group label: Steroid plus NSAID eye drop combination therapy
arm group type: Active Comparator
description: NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
intervention type: Drug
intervention name: Dexamethasone intravitreal implant
arm group label: OZURDEX intraocular implant
other name: OZURDEX
intervention type: Drug
intervention name: Steroid plus NSAID eye drop combination therapy
arm group label: Steroid plus NSAID eye drop combination therapy
other name: Acular LS and Pred Forte
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pravin U Dugel, MD
role: Principal Investigator
affiliation: Retinal Consultants of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Diabetes Mellitus
mesh term: Dexamethasone
mesh term: Prednisolone acetate
mesh term: Ophthalmic Solutions
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations of our study include a small sample size and short-term follow up. Additional studies are needed to determine whether combination therapy with other treatments would be beneficial to patients.
point of contact: 