A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
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
About This Trial
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)
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Surgical implantation of the CPCB-RPE1 implant
Surgical implantation of the CPCB-RPE1 implant