Optimizing surgical delivery of OpRegen for geographic atrophy in AMD patients
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 is testing a new surgical method to deliver OpRegen to see if it can help people with geographic atrophy from age-related macular degeneration improve their vision safely.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 17 sites (Beverly Hills, California and 16 other locations) |
| Trial ID | NCT05626114 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a surgical method for delivering OpRegen in patients suffering from geographic atrophy due to age-related macular degeneration. Participants will undergo a vitreoretinal surgical procedure, and the study will assess the outcomes based on visual acuity and other clinical endpoints. The focus is on determining how well the treatment works and its safety profile in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with geographic atrophy secondary to age-related macular degeneration who can safely undergo the required surgical procedure.
Not a fit: Patients with other significant ocular diseases or systemic conditions that could interfere with the study outcomes may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients with geographic atrophy secondary to age-related macular degeneration.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating age-related macular degeneration, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beverly Hills, California and 16 other locations
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- Retinal Consultants Medical Group — Sacramento, California, United States (Recruiting)
- West Coast Retina — San Francisco, California, United States (Recruiting)
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (Recruiting)
- The Retina Care Center — Baltimore, Maryland, United States (Recruiting)
- The Retina Institute — St Louis, Missouri, United States (Recruiting)
- Sierra Eye Associates — Reno, Nevada, United States (Recruiting)
- Duke Eye Center — Durham, North Carolina, United States (Recruiting)
- Cincinnati Eye Institute — Blue Ash, Ohio, United States (Recruiting)
- Mid Atlantic Retina — Philadelphia, Pennsylvania, United States (Recruiting)
- Tennessee Retina PC — Nashville, Tennessee, United States (Recruiting)
- Austin Clinical Research, LLC — Austin, Texas, United States (Recruiting)
- Retina Consultants of Texas — Bellaire, Texas, United States (Recruiting)
- Piedmont Eye Center — Lynchburg, Virginia, United States (Recruiting)
- Spokane Eye Clinical Research;Spokane Eye Surgery Center — Spokane, Washington, United States (Recruiting)
- Hadassah MC — Jerusalem, Israel (Recruiting)
- Tel Aviv Sourasky MC — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: GR44251 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.