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

August 13, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah MC
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky MC
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Retina-Vitreous Associates Medical Group
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group
      • San Francisco, California, United States, 94109-5520
        • Recruiting
        • West Coast Retina
    • Florida
      • St. Petersburg, Florida, United States, 33711-1141
        • Recruiting
        • Retina Vitreous Associates of Florida
    • Maryland
      • Baltimore, Maryland, United States, 21209-2219
        • Recruiting
        • The Retina Care Center
    • Missouri
      • St Louis, Missouri, United States, 63128-1729
        • Recruiting
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502-1605
        • Recruiting
        • Sierra Eye Associates
    • North Carolina
      • Durham, North Carolina, United States, 27705-4699
        • Recruiting
        • Duke Eye Center
    • Ohio
      • Blue Ash, Ohio, United States, 45242-5537
        • Recruiting
        • Cincinnati Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5109
        • Recruiting
        • Mid Atlantic Retina
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1513
        • Recruiting
        • Tennessee Retina PC
    • Texas
      • Austin, Texas, United States, 78750-2298
        • Recruiting
        • Austin Clinical Research, LLC
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas
    • Virginia
      • Lynchburg, Virginia, United States, 24502-4271
        • Recruiting
        • Piedmont Eye Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Spokane Eye Clinical Research;Spokane Eye Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Biological: OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
Time Frame: 3 months post-surgery
3 months post-surgery
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery
Time Frame: 3 months post-surgery
3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery
Time Frame: 3 months post-surgery
3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR44251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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