Actively Recruiting
A Phase IIb Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Advanced Dry Age-Related Macular Degeneration (Geographic Atrophy)
Led by Regenerative Patch Technologies, LLC · Updated on 2026-03-25
24
Participants Needed
5
Research Sites
678 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
Researchers are conducting a Phase IIb randomized clinical trial to evaluate the safety and effects of the CPCB-RPE1 implant in people with geographic atrophy involving the fovea, a form of advanced dry age-related macular degeneration (AMD). This study aims to better understand how this subretinal implant may impact retinal sensitivity and visual acuity in affected individuals. Participants will be randomly assigned in a 3:1 ratio to receive either the surgical implantation of the CPCB-RPE1 device or a simulated sham implantation procedure. Up to 24 subjects across multiple centers will participate, with up to 18 receiving the active implant and up to 6 undergoing the sham surgery. The implant is placed under the retina through a surgical approach, and the control group receives a procedure mimicking surgery without implant placement. During the study, participants will undergo baseline and follow-up retinal sensitivity testing and visual acuity assessments, with primary outcomes measured one year after implantation. Researchers will monitor safety and efficacy throughout the study, including the ability of participants to complete microperimetry testing and post-operative care. The study will continue until December 2040, covering the screening, treatment, and outcome evaluation periods.
CONDITIONS
Brief 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)
- Geographic atrophy involving the fovea in advanced dry age-related macular degeneration
- Clinical evidence of geographic atrophy area between 4.0 mm2 and 15.0 mm2 involving the fovea
- Geographic atrophy confirmed by biomicroscopy, OCT, or FAF
- Best-corrected visual acuity in the eye to receive implant between 20/200 and 20/63 inclusive
- Eye not receiving the implant must have visual acuity equal or better than the implanted eye
- Medically suitable for pars plana vitrectomy and surgical implant procedure
- Medically suitable for general anesthesia or monitored intravenous sedation if needed
- Pseudophakic in the study eye (intraocular lens implant present)
- Willing and able to provide written informed consent
- Able to complete baseline microperimetry retinal sensitivity testing
- Baseline microperimetry shows at least 5 spots in the perilesional region with retinal sensitivity between 3 and 17 Db
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
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo surgical implantation of the CPCB-RPE1 implant or a simulated sham implantation procedure, followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Approximately 1 year
Participants attend follow-up visits to monitor safety and assess the efficacy of the implant, including changes in retinal sensitivity and visual acuity.
Regular follow-up visits during the year post implantation
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
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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