A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Start Date
8/1/2025
Completion Date
12/1/2040
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 Criteria
Age Range: 55 years to 90 years
Interventions
Surgical implantation of the CPCB-RPE1 implant
Conditions
Locations
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United States
Retina Associates of Southern California
Huntington Beach, California 92647
United States
USC - Keck
Los Angeles, California 90033
United States
University Retina
Lemont, Illinois 60439
United States
Retina Consultants of Texas
The Woodlands, Texas 77384
United States