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 (NCT05626114)
A Phase IIa, Multicenter, Open-label, Single-Arm Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
🩺 Plain-English Summary (8th-Grade Level)
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 incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.
Who can join: Review the eligibility criteria below.
Location: Retina-Vitreous Associates Medical Group — Beverly Hills, California
Age range: 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- Retinal Consultants Medical Group — Sacramento, California
- West Coast Retina — San Francisco, California
- Retina Vitreous Associates of Florida — St. Petersburg, Florida
- The Retina Care Center — Baltimore, Maryland
- The Retina Institute — St Louis, Missouri
- Sierra Eye Associates — Reno, Nevada
- Duke Eye Center — Durham, North Carolina
- Cincinnati Eye Institute — Blue Ash, Ohio
- Mid Atlantic Retina — Philadelphia, Pennsylvania
- Tennessee Retina PC — Nashville, Tennessee
- Austin Clinical Research, LLC — Austin, Texas
- Retina Consultants of Texas — Bellaire, Texas
- Piedmont Eye Center — Lynchburg, Virginia
- Spokane Eye Clinical Research;Spokane Eye Surgery Center — Spokane, Washington
- Hadassah MC — Jerusalem,
- Tel Aviv Sourasky MC — Tel Aviv,
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Geographic Atrophy
- A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) — Scottsdale, Arizona
- A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration — Bakersfield, California
- Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy — Phoenix, Arizona
- A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy — Gilbert, Arizona
- Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy — Phoenix, Arizona
- A Study in Adults With Geographic Atrophy — Bakersfield, California
Explore by condition: All Geographic Atrophy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.