Recruiting
Phase 2

Opregen

Sponsor:

Genentech, Inc.

Code:

NCT05626114

Conditions

Geographic Atrophy

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

OpRegen

Study Details

Brief 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.

Conditions

Geographic Atrophy

Study ID

NCT05626114

Start date

Mar 23, 2023

Status verified date

Aug, 2026

Completion date

Mar 1, 2031

Anticipated

Primary completion date

Mar 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OpRegen

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

Interventions

OpRegen

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Reference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Retina-Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Retinal Consultants Medical Group

Recruiting

Sacramento, California, United States, 95825

West Coast Retina

Recruiting

San Francisco, California, United States, 94109-5520

Retina Vitreous Associates of Florida

Recruiting

St. Petersburg, Florida, United States, 33711-1141

The Retina Care Center

Recruiting

Baltimore, Maryland, United States, 21209-2219

The Retina Institute

Recruiting

St Louis, Missouri, United States, 63128-1729

Sierra Eye Associates

Recruiting

Reno, Nevada, United States, 89502-1605

Duke Eye Center

Recruiting

Durham, North Carolina, United States, 27705-4699

Cincinnati Eye Institute

Recruiting

Blue Ash, Ohio, United States, 45242-5537

Mid Atlantic Retina

Recruiting

Philadelphia, Pennsylvania, United States, 19107-5109

Tennessee Retina PC

Recruiting

Nashville, Tennessee, United States, 37203-1513

Austin Clinical Research, LLC

Recruiting

Austin, Texas, United States, 78750-2298

Retina Consultants of Texas

Recruiting

Bellaire, Texas, United States, 77401

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502-4271

Spokane Eye Clinical Research;Spokane Eye Surgery Center

Recruiting

Spokane, Washington, United States, 99204

More Information

Sponsor

Genentech, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-08-14.