RecruitingPhase 2NCT05626114

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

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


Sponsor

Genentech, Inc.

Enrollment

60 participants

Start Date

Mar 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a cell therapy called OpRegen for people with geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that causes gradual, permanent central vision loss. OpRegen uses retinal pigment epithelium cells grown from stem cells and delivered surgically beneath the retina to replace the dying cells responsible for this condition. The study also includes an optional sub-study using advanced imaging technology called adaptive optics to closely monitor changes in the retina. You may be eligible if: - You are 50 years of age or older - You have been diagnosed with geographic atrophy caused by AMD - Your best corrected vision in the study eye falls within a specific range (29–60 ETDRS letters) - The lens in your study eye has already been replaced (pseudophakic) - You are able to undergo eye surgery under monitored anesthesia You may NOT be eligible if: - You are pregnant or breastfeeding - You have a history of cognitive impairment or dementia - You have a serious or progressive systemic illness - You have any other eye disease affecting the central retina - You have had a retinal detachment, vitrectomy, or glaucoma surgery in the study eye - You have uncontrolled or advanced glaucoma - You have had cataract surgery or eye surgery within 3 months of this procedure - You have had a prior seizure (except a single childhood febrile seizure) — for the sub-study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOpRegen

OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.


Locations(17)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Retinal Consultants Medical Group

Sacramento, California, United States

West Coast Retina

San Francisco, California, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

The Retina Care Center

Baltimore, Maryland, United States

The Retina Institute

St Louis, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Duke Eye Center

Durham, North Carolina, United States

Cincinnati Eye Institute

Blue Ash, Ohio, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Tennessee Retina PC

Nashville, Tennessee, United States

Austin Clinical Research, LLC

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Spokane Eye Clinical Research;Spokane Eye Surgery Center

Spokane, Washington, United States

Hadassah MC

Jerusalem, Israel

Tel Aviv Sourasky MC

Tel Aviv, Israel

View Full Details on ClinicalTrials.gov

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NCT05626114


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