Geographic AtrophyPhase 2NCT05626114
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
A Phase 2 study testing OpRegen in people with Geographic Atrophy, run by Genentech, Inc. at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- OpRegen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 23 Mar 2023to 1 Mar 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol
Who cannot join
- 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
Show all 14Show fewer
- 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:
- 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
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
17 sites in 2 countries
United States15 sites, 15 recruiting
- Recruiting
Austin Clinical Research, LLC
Austin, Texas, 78750-2298
- Recruiting
The Retina Care Center
Baltimore, Maryland, 21209-2219
- Recruiting
Retina Consultants of Texas
Bellaire, Texas, 77401
- Recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
- Recruiting
Cincinnati Eye Institute
Blue Ash, Ohio, 45242-5537
- Recruiting
Duke Eye Center
Durham, North Carolina, 27705-4699
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502-4271
- Recruiting
Tennessee Retina PC
Nashville, Tennessee, 37203-1513
- Recruiting
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107-5109
- Recruiting
Sierra Eye Associates
Reno, Nevada, 89502-1605
- Recruiting
Retinal Consultants Medical Group
Sacramento, California, 95825
- Recruiting
West Coast Retina
San Francisco, California, 94109-5520
- Recruiting
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, 99204
- Recruiting
The Retina Institute
St Louis, Missouri, 63128-1729
- Recruiting
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711-1141
Israel2 sites, 2 recruiting
- Recruiting
Hadassah MC
Jerusalem, 9112001
- Recruiting
Tel Aviv Sourasky MC
Tel Aviv, 6423906
About this study
Official title: 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.
- Conditions
- Geographic Atrophy
- Being tested
- OpRegen
- Keywords
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpRegenBiological
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
| Study group | Role | What they receive |
|---|---|---|
| OpRegen | Experimental | OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space. Receives: Biological: OpRegen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
Measured: 3 months post-surgery
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery
Measured: 3 months post-surgery
Secondary outcomes (1)
Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start23 Mar 2023
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626114
- Sponsor's protocol ID
- GR44251
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Aweidah H, Matsevich C, Khaner H, Idelson M, Ejzenberg A, Reubinoff B, Banin E, Obolensky A. Survival of Neural Progenitors Derived from Human Embryonic Stem Cells Following Subretinal Transplantation in Rodents. J Ocul Pharmacol Ther. 2023 Jun;39(5):347-358. doi: 10.1089/jop.2022.0161. Epub 2023 May 4.
PubMed 37140896