Recruiting
Phase 2

RO7965032

Sponsor:

Genentech, Inc.

Code:

NCT07851259

Conditions

Geographic Atrophy Secondary to Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

RO7965032

Placebo

Study Details

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

Study ID

NCT07851259

Start date

Jan 8, 2027

Status verified date

Oct, 2026

Completion date

Aug 21, 2030

Anticipated

Primary completion date

Aug 21, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

321 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RO7965032 Dose Level 1

Participants will receive RO7965032.

experimental: RO7965032 Dose Level 2

Participants will receive RO7965032.

placebo comparator: Placebo

Participants will receive placebo.

Interventions

RO7965032

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

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

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

Locations

Bay Area Retina Specialists Medical Group - Vestrum - PPDS

Recruiting

Walnut Creek, California, United States, 94598-5915

Piedmont Retina Specialists

Recruiting

Winston-Salem, North Carolina, United States, 27103-6945

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16505

Texas Retina Associates - Arlington

Recruiting

Arlington, Texas, United States, 76012-2505

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502-4271

More Information

Sponsor

Genentech, Inc.

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.