<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/NCT04465955</url>
  </required_header>
  <id_info>
    <org_study_id>621-GA-201</org_study_id>
    <nct_id>NCT04465955</nct_id>
  </id_info>
  <brief_title>A Study of NGM621 in Participants With Geographic Atrophy</brief_title>
  <acronym>CATALINA</acronym>
  <official_title>A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NGM Biopharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NGM Biopharmaceuticals, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled&#xD;
      study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">August 16, 2022</completion_date>
  <primary_completion_date type="Actual">August 16, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment</measure>
    <time_frame>52 Weeks</time_frame>
    <description>The primary efficacy endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham</measure>
    <time_frame>52 Weeks</time_frame>
    <description>The primary safety endpoints</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Geographic Atrophy</condition>
  <arm_group>
    <arm_group_label>NGM621 Treatment Group A (every 4 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NGM621 single intravitreal (IVT) injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NGM621 Treatment Group C (every 8 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NGM621 single IVT injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group B (every 4 weeks)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham single IVT injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group D (every 8 weeks)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham single IVT injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NGM621</intervention_name>
    <description>NGM621 Dose 1</description>
    <arm_group_label>NGM621 Treatment Group A (every 4 weeks)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NGM621</intervention_name>
    <description>NGM621 Dose 2</description>
    <arm_group_label>NGM621 Treatment Group C (every 8 weeks)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Comparator</intervention_name>
    <description>Sham Comparator</description>
    <arm_group_label>Sham Group B (every 4 weeks)</arm_group_label>
    <arm_group_label>Sham Group D (every 8 weeks)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female (non-pregnant, non-lactating) subjects ≥ 55 years&#xD;
&#xD;
          -  Standard luminance BCVA score of 34 letters or better using ETDRS charts at the&#xD;
             starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in&#xD;
             study eye&#xD;
&#xD;
          -  Clinical diagnosis of GA secondary to AMD:&#xD;
&#xD;
               1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm²&#xD;
&#xD;
               2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with&#xD;
                  the overall area of GA ≥ 2.5 and ≤ 17.5 mm²&#xD;
&#xD;
               3. Well demarcated GA with no anatomical evidence of current or prior CNV in the&#xD;
                  study eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Study Eye&#xD;
&#xD;
          -  GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular&#xD;
             dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)&#xD;
&#xD;
          -  Any history of or active choroidal neovascularization (CNV)&#xD;
&#xD;
        Both Eyes&#xD;
&#xD;
          -  Any history of or active bacterial, viral, fungal, or parasitic infection in either&#xD;
             eye in the 3 months prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NGM Study Director</last_name>
    <role>Study Director</role>
    <affiliation>NGM Biopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Associated Retina Consultants</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Retina Consultants</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Associates</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal Diagnostic Center</name>
      <address>
        <city>Campbell</city>
        <state>California</state>
        <zip>95008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Retina Partners</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Orange County</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Retina Vitreous Associates</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Institute of California</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Eye Specialists</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants San Diego</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal Consultants Medical Group Inc</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Retina Medical Group</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Retina Consultants</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Southern Colorado PC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Retina Associates PC</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Retina Associates PC</name>
      <address>
        <city>Waterford</city>
        <state>Connecticut</state>
        <zip>06385</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Eye Microsurgical Institute</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Retina Center (Coral Springs)</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Group of Florida</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Ophthalmic Research Institute</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Eye Associates</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Specialty Institute</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Vitreoretinal Associates</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Associates of Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Retina PC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gailey Eye Clinic - Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Retina and Macula Associates, PC</name>
      <address>
        <city>Lemont</city>
        <state>Illinois</state>
        <zip>60439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raj K. Maturi, MD, PC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates, PA</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thompson Sjaarda, PA</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elman Retina Group PA</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Retina Consultants PC</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Retina Consultants PC</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreoretinal Surgery PA</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deep Blue Retina Clinical Research</name>
      <address>
        <city>Southaven</city>
        <state>Mississippi</state>
        <zip>38671</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Eye Associates</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Vitreoretinal Consultants</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreous Retina Macula Consultants of NY</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Troy Cataract &amp; Laser Associates</name>
      <address>
        <city>Troy</city>
        <state>New York</state>
        <zip>12180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Carolina Retinal Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>18803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Clinical Research</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group, Ltd.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cascade Medical Research Institute</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Specialists</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinovitreous Associates</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Regional Eye Institute</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Retina Associates</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Retina</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Foundation of the Southwest</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates-Plano</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strategic Clinical Research Group, LLC</name>
      <address>
        <city>Willow Park</city>
        <state>Texas</state>
        <zip>76087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spokane Eye Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <disposition_first_submitted>May 31, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>June 13, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 18, 2023</disposition_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</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>Geographic Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Since the study did not meet the study endpoints, there is no plan to make IPD available to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04465955
org study id: 621-GA-201
nct id: NCT04465955
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled
      study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment
time frame: 52 Weeks
description: The primary efficacy endpoint
measure: The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham
time frame: 52 Weeks
description: The primary safety endpoints
arm group label: NGM621 Treatment Group A (every 4 weeks)
arm group type: Experimental
description: NGM621 single intravitreal (IVT) injection
arm group label: NGM621 Treatment Group C (every 8 weeks)
arm group type: Experimental
description: NGM621 single IVT injection
arm group label: Sham Group B (every 4 weeks)
arm group type: Sham Comparator
description: Sham single IVT injection
arm group label: Sham Group D (every 8 weeks)
arm group type: Sham Comparator
description: Sham single IVT injection
intervention type: Biological
intervention name: NGM621
description: NGM621 Dose 1
arm group label: NGM621 Treatment Group A (every 4 weeks)
intervention type: Biological
intervention name: NGM621
description: NGM621 Dose 2
arm group label: NGM621 Treatment Group C (every 8 weeks)
intervention type: Other
intervention name: Sham Comparator
description: Sham Comparator
arm group label: Sham Group B (every 4 weeks)
arm group label: Sham Group D (every 8 weeks)
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: NGM Study Director
role: Study Director
affiliation: NGM Biopharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Geographic Atrophy
mesh term: Atrophy
sharing ipd: No
ipd description: Since the study did not meet the study endpoints, there is no plan to make IPD available to other researchers.