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A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Sponsor: Regenerative Patch Technologies, LLC
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)
Official title: A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Subjects With Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) - PATCH AMD
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-08-01
Completion Date
2040-12
Last Updated
2026-03-25
Healthy Volunteers
No
Interventions
Surgical implantation of the CPCB-RPE1 implant
Surgical implantation of the CPCB-RPE1 implant
Locations (5)
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
USC - Keck
Los Angeles, California, United States
University Retina
Lemont, Illinois, United States
Retina Consultants of Texas
The Woodlands, Texas, United States