<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/NCT03295877</url>
  </required_header>
  <id_info>
    <org_study_id>GR39821</org_study_id>
    <nct_id>NCT03295877</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)</brief_title>
  <official_title>A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 1, open-label, multicenter study will investigate the safety and tolerability of&#xD;
      RO7171009 following single and multiple intravitreal (ITV) administrations in patients with&#xD;
      GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and&#xD;
      Multiple-Dose (MD) stages.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability of the Study Drug: Rate of Adverse Events</measure>
    <time_frame>Through study completion or early study discontinuation (overall 12-20 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Concentration of RO7171009</measure>
    <time_frame>Through study completion or early study discontinuation (overall 12-20 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Geographic Atrophy</condition>
  <arm_group>
    <arm_group_label>RO7171009: SAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a single dose of RO7171009, in multiple escalating cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO7171009: MD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO7171009</intervention_name>
    <description>Patients will receive RO7171009 via ITV injection.</description>
    <arm_group_label>RO7171009: MD</arm_group_label>
    <arm_group_label>RO7171009: SAD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged greater than or equal to (&gt;/=) 50 years&#xD;
&#xD;
          -  Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active&#xD;
             choroidal neovascularization (CNV) in study eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Ocular Exclusion Criteria, Study Eye:&#xD;
&#xD;
          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for&#xD;
             AMD&#xD;
&#xD;
          -  Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein&#xD;
             occlusion, or proliferative diabetic retinopathy&#xD;
&#xD;
          -  Prior treatment with Visudyne®, external beam radiation therapy (for intraocular&#xD;
             conditions), or transpupillary thermotherapy&#xD;
&#xD;
        Ocular Exclusion Criteria (Both Eyes):&#xD;
&#xD;
          -  GA in either eye due to causes other than AMD&#xD;
&#xD;
          -  Evidence of prior or active CNV&#xD;
&#xD;
          -  Previous participation in interventional clinical trials for GA or dry AMD, except for&#xD;
             vitamins and minerals, irrespective of the route of administration (i.e., ocular or&#xD;
             systemic) within the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <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>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>Retinal Consultants Med Group</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</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>California Retina Consultants - Santa Maria</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Southern Colorado PC; Clinical Research Department</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909-1183</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>Georgia Retina PC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Retina Institute</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</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>Western Carolina Retinal Associate PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Retina PC.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</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 Degeneration</mesh_term>
    <mesh_term>Geographic Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_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/NCT03295877
org study id: GR39821
nct id: NCT03295877
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This Phase 1, open-label, multicenter study will investigate the safety and tolerability of
      RO7171009 following single and multiple intravitreal (ITV) administrations in patients with
      GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and
      Multiple-Dose (MD) stages.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Tolerability of the Study Drug: Rate of Adverse Events
time frame: Through study completion or early study discontinuation (overall 12-20 weeks)
measure: Serum Concentration of RO7171009
time frame: Through study completion or early study discontinuation (overall 12-20 weeks)
arm group label: RO7171009: SAD
arm group type: Experimental
description: Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
arm group label: RO7171009: MD
arm group type: Experimental
description: Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.
intervention type: Drug
intervention name: RO7171009
description: Patients will receive RO7171009 via ITV injection.
arm group label: RO7171009: MD
arm group label: RO7171009: SAD
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Geographic Atrophy
mesh term: Atrophy