A Study Assessing the Safety, Tolerability, and Efficacy of RO7171009 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Overview

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of RO7171009 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control.

Full Title of Study: “A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 3, 2022

Interventions

  • Drug: RO7171009
    • Intravitreal (ITV) injections of RO7171009
  • Drug: Sham Control
    • ITV injections of Sham Control

Arms, Groups and Cohorts

  • Experimental: RO7171009 Q4W
    • Participants will receive RO7171009 every 4 weeks (Q4W).
  • Sham Comparator: Sham Control Q4W
    • Participants will receive Sham-control Q4W.
  • Experimental: RO7171009 Q8W
    • Participants will receive RO7171009 every 8 weeks (Q8W).
  • Sham Comparator: Sham Control Q8W
    • Participants will receive Sham-control Q8W.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in GA Area as Measured by Fundus Autofluorescence (FAF) at Week 72
    • Time Frame: Baseline, Week 72

Secondary Measures

  • Percentage of Participants With Ocular Adverse Events
    • Time Frame: From baseline to Week 76
  • Percentage of Participants With Systemic Adverse Events
    • Time Frame: From baseline to Week 76
  • Percentage of Participants With Serious Adverse Events (SAEs)
    • Time Frame: From baseline to Week 76
  • Percentage of Participants with Adverse Events of Special Interest (AESIs)
    • Time Frame: From baseline to Week 76

Participating in This Clinical Trial

Inclusion Criteria

  • Age >/= 60 years at time of signing Informed Consent Form;
  • Visual acuity: best-corrected visual acuity (BCVA) letter score >/= 24 letters (Snellen equivalent of 20/320 or better);
  • Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

Exclusion Criteria

Ocular Exclusion Criteria, Study Eye:

  • History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
  • Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.

Ocular Exclusion Criteria, Both Eyes:

  • GA in either eye due to causes other than AMD;
  • Active uveitis and/or vitritis (grade trace or above) in either eye;
  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
  • Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
  • Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche
  • Overall Contact(s)
    • Reference Study ID Number: GR40973 www.roche.com/about_roche/roche_worldwide.htm, 888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com

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