NCT05626114 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
| NCT ID | NCT05626114 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Genentech, Inc. |
| Condition | Geographic Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2031-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-03-23 with a primary completion date of 2031-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Reference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S. Only)
Clinical Trials
STUDY DIRECTOR
Hoffmann-La Roche
Frequently Asked Questions
Who can join the NCT05626114 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Geographic Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05626114 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05626114 currently recruiting?
Yes, NCT05626114 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT05626114 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Sacramento, United States, San Francisco, United States, St. Petersburg, United States and 11 additional locations.
Who is sponsoring the NCT05626114 clinical trial?
NCT05626114 is sponsored by Genentech, Inc.. The principal investigator is Clinical Trials at Hoffmann-La Roche. The trial plans to enroll 60 participants.