A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251

Recruiting Phase 2 Interventional Study
Geographic Atrophy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Genentech, Inc. · Industry
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About This Trial
This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated. The substudy will evaluate the operational feasibility and scientific interpretability of incorporati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care * Diagnosis of GA secondary to AMD * Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)…
Contacts

Reference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

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