Actively Recruiting
A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Led by Regenerative Patch Technologies, LLC · Updated on 2026-03-25
24
Participants Needed
5
Research Sites
800 weeks
Total Duration
On this page
Sponsors
R
Regenerative Patch Technologies, LLC
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 to 90 years inclusive with geographic atrophy involving the fovea in advanced dry AMD
- Clinical evidence of geographic atrophy area between 4.0 mm2 and 15.0 mm2 involving the fovea
- Geographic atrophy defined by loss or thinning of retinal pigment epithelium seen by biomicroscopy, OCT, or FAF
- Best-corrected visual acuity in the study eye between 20/200 (35 EDTRS letters) and 20/63 (60 EDTRS letters)
- Visual acuity in the fellow eye equal to or better than the study eye
- Medically suitable for pars plana vitrectomy and surgical implantation, including ability to use postoperative positioning and medications
- Medically suitable for general anesthesia or monitored IV sedation if needed
- Pseudophakic in the study eye to reduce cataract risk after surgery
- Willing and able to provide signed informed consent
- Able to complete baseline retinal sensitivity testing via microperimetry
- Baseline microperimetry showing at least 5 spots with retinal sensitivity between 3 and 17 dB in the perilesional area
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
Actively Recruiting
3
USC - Keck
Los Angeles, California, United States, 90033
Actively Recruiting
4
University Retina
Lemont, Illinois, United States, 60439
Actively Recruiting
5
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384
Actively Recruiting
Research Team
C
Clinical Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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