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Recruiting Phase 2

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

NCT07851259 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2027-01-08
Last updated
2026-10-26

Condition(s) studied

Geographic Atrophy Secondary to Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

RO7965032Placebo

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.

Study 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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (5)

FacilityCityRegionStatus
Bay Area Retina Specialists Medical Group - Vestrum - PPDS Walnut Creek California Recruiting
Piedmont Retina Specialists Winston-Salem North Carolina Recruiting
Erie Retina Research Erie Pennsylvania Recruiting
Texas Retina Associates - Arlington Arlington Texas Recruiting
Piedmont Eye Center Lynchburg Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07851259 on ClinicalTrials.gov ↗ ← All trials in the USA