<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/NCT02186119</url>
  </required_header>
  <id_info>
    <org_study_id>150998-004</org_study_id>
    <secondary_id>PALM</secondary_id>
    <nct_id>NCT02186119</nct_id>
  </id_info>
  <brief_title>A Study of Abicipar Pegol in Patients With Diabetic Macular Edema</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety and efficacy study of abicipar pegol in patients with diabetic macular&#xD;
      edema.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Baseline, Week 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale</measure>
    <time_frame>Baseline, 28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye</measure>
    <time_frame>Baseline, Week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients with a BCVA of ≥70 Letters</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients with Resolution of Macular Edema</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Macular Edema</condition>
  <arm_group>
    <arm_group_label>abicipar pegol 2 mg (group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abicipar pegol 2 mg (group B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abicipar pegol 1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ranibizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>abicipar pegol</intervention_name>
    <description>Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.</description>
    <arm_group_label>abicipar pegol 1 mg</arm_group_label>
    <arm_group_label>abicipar pegol 2 mg (group A)</arm_group_label>
    <arm_group_label>abicipar pegol 2 mg (group B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ranibizumab</intervention_name>
    <description>Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.</description>
    <arm_group_label>ranibizumab</arm_group_label>
    <other_name>Lucentis®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham procedure</intervention_name>
    <description>Sham procedure to the study eye at the visits noted per protocol.</description>
    <arm_group_label>abicipar pegol 1 mg</arm_group_label>
    <arm_group_label>abicipar pegol 2 mg (group A)</arm_group_label>
    <arm_group_label>abicipar pegol 2 mg (group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus (Type 1 or 2)&#xD;
&#xD;
          -  Decreased vision due to diabetic macular edema in at least 1 eye&#xD;
&#xD;
          -  Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better&#xD;
             in the fellow eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke or heart attack within the past 3 months&#xD;
&#xD;
          -  History of vitrectomy, macular surgery, or glaucoma surgery in the study eye&#xD;
&#xD;
          -  Cataract or refractive surgery in the study eye within the last 3 months&#xD;
&#xD;
          -  Laser photocoagulation of the study eye within the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 10, 2015</last_update_submitted>
  <last_update_submitted_qc>July 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranibizumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02186119
org study id: 150998-004
secondary id: PALM
nct id: NCT02186119
lead sponsor: 
has dmc: Yes
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular
      edema.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA)
time frame: Baseline, Week 28
measure: Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
time frame: Baseline, 28 Weeks
measure: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
time frame: Baseline, Week 28
measure: Percentage of Patients with a BCVA of ≥70 Letters
time frame: 28 Weeks
measure: Percentage of Patients with Resolution of Macular Edema
time frame: 28 Weeks
arm group label: abicipar pegol 2 mg (group A)
arm group type: Experimental
description: Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.
arm group label: abicipar pegol 2 mg (group B)
arm group type: Experimental
description: Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
arm group label: abicipar pegol 1 mg
arm group type: Experimental
description: Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
arm group label: ranibizumab
arm group type: Active Comparator
description: Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
intervention type: Drug
intervention name: abicipar pegol
description: Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
arm group label: abicipar pegol 1 mg
arm group label: abicipar pegol 2 mg (group A)
arm group label: abicipar pegol 2 mg (group B)
intervention type: Drug
intervention name: ranibizumab
description: Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
arm group label: ranibizumab
other name: Lucentis®
intervention type: Other
intervention name: sham procedure
description: Sham procedure to the study eye at the visits noted per protocol.
arm group label: abicipar pegol 1 mg
arm group label: abicipar pegol 2 mg (group A)
arm group label: abicipar pegol 2 mg (group B)
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Ranibizumab