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

Last updated: April 19, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

OpRegen

Clinical Study ID

NCT05626114
GR44251
  • Ages > 50
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Ability to undergo a vitreoretinal surgical procedure under monitored anesthesiacare

  • Diagnosis of GA secondary to AMD

  • Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the studyeye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)

  • Pseudophakic (study eye)

Exclusion

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, orchange to such an extent that it may bias the assessment of the clinical status ofthe 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 assessmentof 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 subretinalsurgical delivery of OpRegen

  • History of other ocular or intraocular conditions that contraindicate the use of aninvestigational drug or may affect interpretation of the study results or may renderthe 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 singlefebrile seizure in childhood

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: OpRegen
Phase: 2
Study Start date:
March 23, 2023
Estimated Completion Date:
March 01, 2031

Connect with a study center

  • Hadassah MC

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah MC; Ophtalmology

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah MC

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky MC

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95825
    United States

    Active - Recruiting

  • West Coast Retina

    San Francisco, California 94109-5520
    United States

    Active - Recruiting

  • Retina-Vitreous Associates Medical Group

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento 5389489, California 5332921 95825
    United States

    Site Not Available

  • West Coast Retina

    San Francisco 5391959, California 5332921 94109-5520
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida

    St. Petersburg 4171563, Florida 4155751 33711
    United States

    Site Not Available

  • The Retina Care Center

    Baltimore, Maryland 21209-2219
    United States

    Active - Recruiting

  • The Retina Care Center

    Baltimore 4347778, Maryland 4361885 21209-2219
    United States

    Site Not Available

  • The Retina Institute

    Saint Louis, Missouri 63128-1729
    United States

    Site Not Available

  • The Retina Institute

    St Louis, Missouri 63128-1729
    United States

    Active - Recruiting

  • The Retina Institute

    St Louis 4407066, Missouri 4398678 63128-1729
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502-1605
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno 5511077, Nevada 5509151 89502-1605
    United States

    Site Not Available

  • Mid Atlantic Retina

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Duke Eye Center

    Durham, North Carolina 27705-4699
    United States

    Active - Recruiting

  • Duke Eye Center

    Durham 4464368, North Carolina 4482348 27705-4699
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Blue Ash, Ohio 45242-5537
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Blue Ash 4506754, Ohio 5165418 45242-5537
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107-5109
    United States

    Active - Recruiting

  • Mid Atlantic Retina

    Philadelphia 4560349, Pennsylvania 6254927 19107-5109
    United States

    Site Not Available

  • Tennessee Retina PC

    Nashville, Tennessee 37203-1513
    United States

    Active - Recruiting

  • Tennessee Retina PC

    Nashville 4644585, Tennessee 4662168 37203-1513
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin, Texas 78750-2298
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Austin Clinical Research, LLC

    Austin 4671654, Texas 4736286 78750-2298
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502-4271
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg 4771075, Virginia 6254928 24502-4271
    United States

    Site Not Available

  • Spokane Eye Clinical Research;Spokane Eye Surgery Center

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research;Spokane Eye Surgery Center

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

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