<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/NCT02214628</url>
  </required_header>
  <id_info>
    <org_study_id>OPH1005</org_study_id>
    <nct_id>NCT02214628</nct_id>
  </id_info>
  <brief_title>Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD</brief_title>
  <official_title>A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ophthotech Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ophthotech</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered&#xD;
      in combination with anti-VEGF therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered&#xD;
      in combination with anti-VEGF therapy in either a &quot;Simultaneous&quot; Regimen (Fovista®&#xD;
      administered with anti-VEGF same day) or &quot;Pre-Treatment&quot; Regimen (monotherapy Fovista® Day 0&#xD;
      followed by Fovista® administered in combination with anti-VEGF Day 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Number of Subject With Non Serious Adverse Events (Reported by &gt;5% of Subjects)</measure>
    <time_frame>2 years</time_frame>
    <description>Number of subjects on either arm with non-serious adverse events (reported by &gt;5% of subjects)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects With Serious Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>Number of subjects with serious adverse events in each arm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Fovista® plus anti-VEGF Simultaneous</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Simultaneous&quot; regimen followed by quarterly administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fovista® plus anti-VEGF Pre-Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Pre-Treatment&quot; regimen followed by quarterly administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fovista® (anti-PDGF BB) plus anti-VEGF</intervention_name>
    <arm_group_label>Fovista® plus anti-VEGF Pre-Treatment</arm_group_label>
    <arm_group_label>Fovista® plus anti-VEGF Simultaneous</arm_group_label>
    <other_name>Fovista®</other_name>
    <other_name>anti-VEGF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of either gender aged ≥ 50 years&#xD;
&#xD;
          -  All fluorescein angiographic subtypes with presence of active choroidal&#xD;
             neovascularization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any&#xD;
             prior thermal laser in the macular region, regardless of indication&#xD;
&#xD;
          -  Subjects with subfoveal scar or subfoveal atrophy&#xD;
&#xD;
          -  Any ocular or periocular infection in the past twelve (12) weeks&#xD;
&#xD;
          -  History of any of the following conditions or procedures in the study eye:&#xD;
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.&#xD;
             trabeculectomy), glaucoma drainage device, corneal transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oak Forest</city>
        <state>Illinois</state>
        <zip>60452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>49202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>October 23, 2018</results_first_submitted>
  <results_first_submitted_qc>June 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 10, 2019</results_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wet AMD</keyword>
  <keyword>Choroidal neovascularization</keyword>
  <keyword>Fovista®</keyword>
  <keyword>E10030</keyword>
  <keyword>Avastin®</keyword>
  <keyword>Eylea®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Becaplermin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen</title>
          <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Simultaneous&quot; regimen followed by quarterly administration.</description>
        </group>
        <group group_id="P2">
          <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen</title>
          <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Pre-Treatment&quot; regimen followed by quarterly administration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous</title>
          <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Simultaneous&quot; regimen followed by quarterly administration</description>
        </group>
        <group group_id="B2">
          <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen</title>
          <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Pre-Treatment&quot; regimen followed by quarterly administration</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="63"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="92"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.3" spread="7.92"/>
                    <measurement group_id="B2" value="74.8" spread="9.89"/>
                    <measurement group_id="B3" value="77.0" spread="8.82"/>
                  </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="40"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="32"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subject With Non Serious Adverse Events (Reported by &gt;5% of Subjects)</title>
        <description>Number of subjects on either arm with non-serious adverse events (reported by &gt;5% of subjects)</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen</title>
            <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Simultaneous&quot; regimen followed by quarterly administration.</description>
          </group>
          <group group_id="O2">
            <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen</title>
            <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Pre-Treatment&quot; regimen followed by quarterly administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subject With Non Serious Adverse Events (Reported by &gt;5% of Subjects)</title>
          <description>Number of subjects on either arm with non-serious adverse events (reported by &gt;5% of subjects)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Serious Adverse Events</title>
        <description>Number of subjects with serious adverse events in each arm</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen</title>
            <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Simultaneous&quot; regimen followed by quarterly administration</description>
          </group>
          <group group_id="O2">
            <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen</title>
            <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Pre-Treatment&quot; regimen followed by quarterly administration</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Serious Adverse Events</title>
          <description>Number of subjects with serious adverse events in each arm</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to a maximum exposure of 24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen</title>
          <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Simultaneous&quot; regimen followed by quarterly administration.</description>
        </group>
        <group group_id="E2">
          <title>Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen</title>
          <description>Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a &quot;Pre-Treatment&quot; regimen followed by quarterly administration.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Surgical failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendiceal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Facial bone fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Perirenal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc displacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Metastasis to lung</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Metastatic squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <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="51" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="63"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Conjuctival haemorrhage</sub_title>
                <counts group_id="E1" events="87" subjects_affected="31" subjects_at_risk="63"/>
                <counts group_id="E2" events="42" subjects_affected="20" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="63"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="63"/>
                <counts group_id="E2" events="26" subjects_affected="9" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Neovascular age-related macular degeneration</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="63"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </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>Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Keith Westby</name_or_title>
      <organization>Ophthotech Corp.</organization>
      <phone>732-824-7474</phone>
      <email>keith.westby@ophthotech.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/NCT02214628
org study id: OPH1005
nct id: NCT02214628
lead sponsor: 
has dmc: No
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered
      in combination with anti-VEGF therapy.
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered
      in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista®
      administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0
      followed by Fovista® administered in combination with anti-VEGF Day 2).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
time frame: 2 years
description: Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)
measure: Number of Subjects With Serious Adverse Events
time frame: 2 years
description: Number of subjects with serious adverse events in each arm
arm group label: Fovista® plus anti-VEGF Simultaneous
arm group type: Experimental
description: Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
arm group label: Fovista® plus anti-VEGF Pre-Treatment
arm group type: Experimental
description: Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
intervention type: Drug
intervention name: Fovista® (anti-PDGF BB) plus anti-VEGF
arm group label: Fovista® plus anti-VEGF Pre-Treatment
arm group label: Fovista® plus anti-VEGF Simultaneous
other name: Fovista®
other name: anti-VEGF
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Becaplermin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 