Ireland
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Recruiting Phase 2

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

NCT06557460 · tracked via the Priya Life Science USA tracker
Sponsor
Regenerative Patch Technologies, LLC
Phase
Phase 2
Started
2025-08-01
Last updated
2026-09-23

Condition(s) studied

Dry Age-related Macular DegenerationGeographic Atrophy

Investigational drug(s) / intervention(s)

Surgical implantation of the CPCB-RPE1 implant

Surgical implantation of the CPCB-RPE1 implant: Surgical implantation of the CPCB-RPE1 implant

Study 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

Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in retinal sensitivity — 1 year post implantation
    Change in retinal sensitivity by microperimetry

Trial sites (5)

FacilityCityRegionStatus
Retina Associates of Southern California Huntington Beach California Recruiting
USC - Keck Los Angeles California Recruiting
University Retina Lemont Illinois Recruiting
Austin Retina Associates Austin Texas Recruiting
Retina Consultants of Texas The Woodlands Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06557460 on ClinicalTrials.gov ↗ ← All trials in the USA