Tests a cell patch implant for advanced dry macular degeneration
Tests a surgically implanted retinal cell patch in adults with dry macular degeneration.
Plain-language title generated from the registry record
Registry title: A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Key facts
- Where
- Austin, Huntington Beach, Lemont, Los Angeles, and The Woodlands, United StatesSee the 5 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
Source: NCT06557460, who can take part
Where in United States
- Austin Retina AssociatesAustin, United StatesTaking people
- Retina Associates of Southern CaliforniaHuntington Beach, United StatesTaking people
- University RetinaLemont, United StatesTaking people
- USC KeckLos Angeles, United StatesTaking people
- Retina Consultants of TexasThe Woodlands, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regenerative Patch Technologies, LLC
- Trial code
- NCT06557460
- Record updated
- 23 September 2026
- Original description
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.Read full original descriptionShow less
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 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)
Eligible participants include:; Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD; 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; Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF; 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; 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; Medically suitable for general anesthesia or monitored intravenous sedation, if needed; Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy; Participants also must be willing and able to provide written, signed informed consent for this study; Participants able to complete the baseline microperimetry retinal sensitivity testing; On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.