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NCT05626114PHASE2Recruiting

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

Genentech, Inc.

Start Date

3/23/2023

Completion Date

3/1/2031

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 Criteria

Age Range: 50 years to No maximum

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) * Pseudophakic (study eye) Exclusion Criteria: * Pregnancy or breastfeeding * History of cognitive impairment or dementia * Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk Ocular Exclusion Criteria for Study Eye: * Any current or history of ocular disease other than GA that may confound assessment of the macula * History of retinal detachment * History of vitrectomy, glaucoma-filtering surgery, or corneal transplant * Uncontrolled glaucoma or advanced glaucoma * Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen * History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications * Any existing posterior segment device or implant Substudy: Inclusion Criteria: \- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol Exclusion Criteria: * Participants who meet any exclusion criteria listed in the parent study GR44251 * Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood

Interventions

BIOLOGICAL

OpRegen

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Conditions

Geographic Atrophy

Locations

Retina-Vitreous Associates Medical Group

Beverly Hills, California 90211

United States

Retinal Consultants Medical Group

Sacramento, California 95825

United States

West Coast Retina

San Francisco, California 94109-5520

United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida 33711-1141

United States

The Retina Care Center

Baltimore, Maryland 21209-2219

United States

The Retina Institute

St Louis, Missouri 63128-1729

United States

Sierra Eye Associates

Reno, Nevada 89502-1605

United States

Duke Eye Center

Durham, North Carolina 27705-4699

United States

Cincinnati Eye Institute

Blue Ash, Ohio 45242-5537

United States

Mid Atlantic Retina

Philadelphia, Pennsylvania 19107-5109

United States

Tennessee Retina PC

Nashville, Tennessee 37203-1513

United States

Austin Clinical Research, LLC

Austin, Texas 78750-2298

United States

Retina Consultants of Texas

Bellaire, Texas 77401

United States

Piedmont Eye Center

Lynchburg, Virginia 24502-4271

United States

Spokane Eye Clinical Research;Spokane Eye Surgery Center

Spokane, Washington 99204

United States

Hadassah MC

Jerusalem, 9112001

Israel

Tel Aviv Sourasky MC

Tel Aviv, 6423906

Israel