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
RECRUITINGRetina Associates of Southern California
Huntington Beach, California, United States
RECRUITINGUSC - Keck
Los Angeles, California, United States
RECRUITINGUniversity Retina
Lemont, Illinois, United States
RECRUITINGRetina Consultants of Texas
The Woodlands, Texas, United States
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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