Subretinal CPCB-RPE1 implant for advanced dry AMD with geographic atrophy
A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Subjects With Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) - PATCH AMD
This trial will try a surgical CPCB-RPE1 implant in one eye to see if it is safe and helps people aged 55–90 with advanced dry AMD and geographic atrophy that involves the fovea.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | Regenerative Patch Technologies, LLC Industry-sponsored |
| Locations | 5 sites (Beverly Hills, California and 4 other locations) |
| Trial ID | NCT06557460 on ClinicalTrials.gov |
What this trial studies
This is a Phase IIb randomized, multicenter trial testing a unilateral subretinal CPCB-RPE1 implant versus a simulated sham procedure. Twenty-four participants will be randomized 3:1 (up to 18 receiving the implant and up to 6 receiving sham) and treated at up to six surgical implantation sites with additional referral or follow-up centers as needed. Eligible eyes must have geographic atrophy involving the fovea between 4.0 mm2 and 15.0 mm2 and best-corrected visual acuity between 20/200 and 20/63. Participants must be medically suitable for pars plana vitrectomy and perioperative anesthesia and able to comply with postoperative positioning and medications.
Who should consider this trial
Good fit: Ideal candidates are people aged 55–90 with geographic atrophy involving the fovea (4.0–15.0 mm2) and best-corrected visual acuity of 20/200 to 20/63 in the eye to be treated who are medically fit for vitrectomy and anesthesia.
Not a fit: Patients outside the age or lesion-size criteria, with vision worse than 20/200 or better than 20/63 in the treated eye, with other major ocular comorbidities, or who are not surgical candidates are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the implant could preserve or partially restore central vision in eyes with foveal geographic atrophy and slow further vision loss.
How similar studies have performed: Early-phase trials of RPE patch implants and related retinal cell therapies have shown acceptable safety in some cases and occasional vision improvement, but these approaches remain experimental and results have been variable.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligible participants include: 1. Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD. 2. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 15.0 mm2 of geographic atrophy involving the fovea. 3. Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF. 4. The best-corrected visual acuity (BCVA) of the eye to receive the implant will be ≥20/200 (35 EDTRS letters) to 20/63 (60 EDTRS letters) inclusive. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant. 5. Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required. 6. Medically suitable for general anesthesia or monitored intravenous sedation, if needed. 7. Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy. 8. Participants also must be willing and able to provide written, signed informed consent for this study. 9. Participants able to complete the baseline microperimetry retinal sensitivity testing. 10. On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.
Where this trial is running
Beverly Hills, California and 4 other locations
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- Retina Associates of Southern California — Huntington Beach, California, United States (Recruiting)
- USC - Keck — Los Angeles, California, United States (Recruiting)
- University Retina — Lemont, Illinois, United States (Recruiting)
- Retina Consultants of Texas — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Research
- Email: clinicaltrials@regenerativepatch.com
- Phone: 833-734-3678
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.