NCT07851259 A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
| NCT ID | NCT07851259 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Genentech, Inc. |
| Condition | Geographic Atrophy Secondary to Age-Related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 321 participants |
| Start Date | 2027-01-08 |
| Primary Completion | 2030-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 321 participants in total. It began in 2027-01-08 with a primary completion date of 2030-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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
Contact & Investigator
Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S. and Canada)
Frequently Asked Questions
Who can join the NCT07851259 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Geographic Atrophy Secondary to Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07851259 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07851259 currently recruiting?
Yes, NCT07851259 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT07851259 trial being conducted?
This trial is being conducted at Walnut Creek, United States, Winston-Salem, United States, Erie, United States, Arlington, United States and 1 additional location.
Who is sponsoring the NCT07851259 clinical trial?
NCT07851259 is sponsored by Genentech, Inc.. The trial plans to enroll 321 participants.