A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Change in retinal sensitivity — 1 year post implantation
Change in retinal sensitivity by microperimetry
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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