Actively Recruiting
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
Led by Genentech, Inc. · Updated on 2026-04-21
60
Participants Needed
17
Research Sites
414 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
- Diagnosis of geographic atrophy secondary to age-related macular degeneration
- Best corrected visual acuity (BCVA) score 29 letters and 240 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)
- Pseudophakic (study eye)
You will not qualify if you...
- Pregnancy or breastfeeding
- History of cognitive impairment or dementia
- Any systemic disease or treatment that could affect clinical status or increase risk as judged by the investigator
- Any current or history of ocular disease other than geographic atrophy that may affect macula assessment
- History of retinal detachment
- History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
- Uncontrolled or advanced glaucoma
- Any cataract or intraocular surgery within 3 months prior to OpRegen delivery
- History of ocular or intraocular conditions contraindicating investigational drug use or increasing treatment risk
- Any existing posterior segment device or implant
- Past history of seizures or epilepsy except a single febrile seizure in childhood
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Retinal Consultants Medical Group
Sacramento, California, United States, 95825
Actively Recruiting
3
West Coast Retina
San Francisco, California, United States, 94109-5520
Actively Recruiting
4
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711
Actively Recruiting
5
The Retina Care Center
Baltimore, Maryland, United States, 21209-2219
Actively Recruiting
6
The Retina Institute
St Louis, Missouri, United States, 63128-1729
Actively Recruiting
7
Sierra Eye Associates
Reno, Nevada, United States, 89502-1605
Actively Recruiting
8
Duke Eye Center
Durham, North Carolina, United States, 27705-4699
Actively Recruiting
9
Cincinnati Eye Institute
Blue Ash, Ohio, United States, 45242-5537
Actively Recruiting
10
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107-5109
Actively Recruiting
11
Tennessee Retina PC
Nashville, Tennessee, United States, 37203-1513
Actively Recruiting
12
Austin Clinical Research, LLC
Austin, Texas, United States, 78750-2298
Actively Recruiting
13
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
14
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502-4271
Actively Recruiting
15
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, United States, 99204
Actively Recruiting
16
Hadassah MC
Jerusalem, Israel, 9112001
Actively Recruiting
17
Tel Aviv Sourasky MC
Tel Aviv, Israel, 6423906
Actively Recruiting
Research Team
R
Reference Study ID Number: GR44251 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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