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RECRUITING
NCT05626114
PHASE2

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

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-03-23

Completion Date

2031-03-01

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

OpRegen

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