NCT06557460 A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
| NCT ID | NCT06557460 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Regenerative Patch Technologies, LLC |
| Condition | Dry Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12 |
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 24 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12.
⚠ 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 is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea. Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups: * The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). * The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06557460 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying Dry Age-related Macular Degeneration. 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 NCT06557460 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 NCT06557460 currently recruiting?
Yes, NCT06557460 is actively recruiting participants. Contact the research team at clinicaltrials@regenerativepatch.com for enrollment information.
Where is the NCT06557460 trial being conducted?
This trial is being conducted at Huntington Beach, United States, Los Angeles, United States, Lemont, United States, Austin, United States and 1 additional location.
Who is sponsoring the NCT06557460 clinical trial?
NCT06557460 is sponsored by Regenerative Patch Technologies, LLC. The trial plans to enroll 24 participants.