A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

October 22, 2026 updated by: Genentech, Inc.

A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This study will assess the safety and efficacy of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

321

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

  • Name: Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
  • Phone Number: 888-662-6728 (U.S. and Canada)
  • Email: global-roche-genentech-trials@gene.com

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598-5915
        • Recruiting
        • Bay Area Retina Specialists Medical Group - Vestrum - PPDS
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103-6945
        • Recruiting
        • Piedmont Retina Specialists
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • Erie Retina Research
    • Texas
      • Arlington, Texas, United States, 76012-2505
        • Recruiting
        • Texas Retina Associates - Arlington
    • Virginia
      • Lynchburg, Virginia, United States, 24502-4271
        • Recruiting
        • Piedmont Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Ocular Inclusion Criteria for the Study Eye

  • BCVA score of >= 35 letters using the ETDRS VA chart at a starting distance of 4 meters
  • Lesions may be either extrafoveal or subfoveal

Ocular Inclusion Criteria for Both Eyes

  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
  • Well-demarcated GA secondary to AMD

Exclusion Criteria:

General Exclusion Criteria - History of hypersensitivity, a severe allergic reaction or anaphylactic reaction to any component of the investigational drug injection

Ocular Exclusion Criteria for the Study Eye

  • History of diabetic macular edema (DME), retinal vein occlusion, corneal transplant, retinal detachment, Stage 3 or 4 macular hole, optic neuropathy, or retinal dystrophy
  • Current or prior history of central serous retinopathy
  • Aphakia or absence of the posterior capsule in the study eye

Ocular Exclusion Criteria for the Non-Study Eye

- Non-functioning non-study eye defined as either BCVA of hand motion or worse or no physical presence of non-study eye (i.e., monocular)

Ocular Exclusion Criteria for Either Eye

  • Proliferative diabetic retinopathy
  • History of recurrent infectious or inflammatory ocular disease
  • Current or prior history of choroidal neovascularization (CNV) in either eye
  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo

Participants will receive placebo.
Drug: Placebo

Placebo will be administered as per the schedule defined in the protocol.
Experimental: RO7965032 Dose Level 1

Participants will receive RO7965032.
Drug: RO7965032

RO7965032 will be administered as per the schedule defined in the protocol.
Experimental: RO7965032 Dose Level 2

Participants will receive RO7965032.
Drug: RO7965032

RO7965032 will be administered as per the schedule defined in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of GA Lesion Area in the Study Eye
Time Frame: Baseline up to approximately 48 weeks
Baseline up to approximately 48 weeks
Incidence and Severity of Ocular Adverse Events (AEs)
Time Frame: Up to approximately 72 Weeks
Up to approximately 72 Weeks
Incidence and Severity of Non-Ocular AEs
Time Frame: Up to approximately 72 Weeks
Up to approximately 72 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of GA Lesion Area in the Study Eye
Time Frame: Baseline up to approximately 72 weeks
Baseline up to approximately 72 weeks
Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time Frame: Baseline up to approximately 48 weeks
Baseline up to approximately 48 weeks
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
Time Frame: Baseline up to approximately 48 weeks
Baseline up to approximately 48 weeks
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Time Frame: Up to approximately 72 Weeks
Up to approximately 72 Weeks
Plasma Concentration of RO7965032
Time Frame: Baseline up to approximately 72 weeks
Baseline up to approximately 72 weeks
Percent Change from Baseline in Levels of Target Protein in Plasma
Time Frame: Baseline up to approximately 72 weeks
Baseline up to approximately 72 weeks
Percent Change from Baseline in Levels of Plasma Biomarker Activity
Time Frame: Baseline up to approximately 72 weeks
Baseline up to approximately 72 weeks
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Time Frame: Baseline up to approximately 72 weeks
Baseline up to approximately 72 weeks
Recommended Dose of RO7965032
Time Frame: Up to approximately 72 Weeks
Up to approximately 72 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2027

Primary Completion (Estimated)

August 21, 2030

Study Completion (Estimated)

August 21, 2030

Study Registration Dates

First Submitted

September 25, 2026

First Submitted That Met QC Criteria

September 25, 2026

First Posted (Actual)

October 1, 2026

Study Record Updates

Last Update Posted (Actual)

October 26, 2026

Last Update Submitted That Met QC Criteria

October 22, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • XR46785
  • 2026-527027-10-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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