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

NCT07851259 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: XR467852026-527027-10-00
• Study Type: interventional
• Target: 321
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Geographic Atrophy Secondary to Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• Change of GA Lesion Area in the Study Eye

  Baseline up to approximately 48 weeks

• Incidence and Severity of Ocular Adverse Events (AEs)

  Up to approximately 72 Weeks

• Incidence and Severity of Non-Ocular AEs

  Up to approximately 72 Weeks

Secondary Outcomes (9)

• Change of GA Lesion Area in the Study Eye

  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

  Baseline up to approximately 48 weeks

• Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions

  Baseline up to approximately 48 weeks

• Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging

  Up to approximately 72 Weeks

• Plasma Concentration of RO7965032

  Baseline up to approximately 72 weeks

Study Arms (3)

RO7965032 Dose Level 1

EXPERIMENTAL

Participants will receive RO7965032.

Drug: RO7965032

RO7965032 Dose Level 2

EXPERIMENTAL

Participants will receive RO7965032.

Drug: RO7965032

Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

RO7965032 DRUG

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

RO7965032 Dose Level 1; RO7965032 Dose Level 2

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BCVA score of \>= 35 letters using the ETDRS VA chart at a starting distance of 4 meters
• Lesions may be either extrafoveal or subfoveal
• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
• Well-demarcated GA secondary to AMD

You may not qualify if:

• 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
• \- 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)
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Central Study Contacts

Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): August 21, 2030
• Study Completion (Estimated): August 21, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share