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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Surgical implantation of the CPCB-RPE1 implant
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
NOT_YET_RECRUITINGRetina Associates of Southern California
Huntington Beach, California, United States
RECRUITINGUSC - Keck
Los Angeles, California, United States
RECRUITINGUniversity Retina
Lemont, Illinois, United States
NOT_YET_RECRUITINGRetina Consultants of Texas
The Woodlands, Texas, United States
NOT_YET_RECRUITINGChange in retinal sensitivity
Change in retinal sensitivity by microperimetry
Time frame: 1 year post implantation
Change in best corrected visual acuity
Change in best corrected visual acuity
Time frame: 1 year post implantation
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