Survival of Neural Progenitors Derived from Human Embryonic Stem Cells Following Subretinal Transplantation in Rodents.
Hamzah Aweidah, Chen Matsevich, Hanita Khaner...
https://pubmed.ncbi.nlm.nih.gov/37140896Actively Recruiting
Phase 2
Age: 50Years +
All Genders
ID05626114
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
Led by Genentech, Inc. · Updated on 2026-05-20
60
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and success of delivering OpRegen cells through subretinal surgery in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This Phase IIa trial also includes a substudy to explore the use of a special retinal imaging device, EarlySight Cellularis Discovery, to better understand retinal changes. The imaging device is used only for assessment and does not affect treatment or clinical care. In this study, participants will receive a dose of up to approximately 200,000 OpRegen cells injected into the subretinal space of the affected eye. The study is open-label and single-arm, meaning all participants receive this treatment and there is no placebo group. The substudy involves additional imaging assessments to evaluate the feasibility and scientific value of the new retinal imaging technology. Participants will be monitored closely after surgery, including assessments of how well the OpRegen cells were delivered and the occurrence of any procedure-related side effects within three months. Researchers will use optical coherence tomography (OCT) imaging to look for structural improvements in the retina after treatment. The study will assess outcomes primarily in the treated eye. Overall participation duration and follow-up details beyond three months are not specified.
CONDITIONS
Brief 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
Age: 50Years +
All Genders
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 score between 29 and 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study
- Study eye is pseudophakic (has an artificial lens implant)
You will not qualify if you...
- Pregnancy or breastfeeding
- History of cognitive impairment or dementia
- Any systemic disease or treatment that may progress or affect clinical assessment or increase risk
- Any current or history of ocular disease other than geographic atrophy that may confound macula assessment
- History of retinal detachment
- History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
- Uncontrolled or advanced glaucoma
- Cataract or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
- History of ocular or intraocular conditions contraindicating investigational drug use or increasing treatment risk
- Presence of any existing posterior segment device or implant
- For substudy: history of seizures except a single febrile seizure in childhood
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo subretinal surgical delivery of OpRegen followed by immediate post-operative care.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 3 months
Participants are monitored for safety and retinal structure improvements after surgery.
Approximately 6 post-operative visits
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, 33711-1141
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
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Research Team
R
Reference Study ID Number: GR44251 https://forpatients.roche.com/
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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