Phase IIb Trial of Subretinal CPCB-RPE1 Implant for Advanced Dry Age-Related Macular Degeneration with Geographic Atrophy

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 31 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.

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)