Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD
The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety of Human Embryonic Stem Cell-Derived RPE Cells on a parylene membrane (CPCB-RPE1) in patients with advanced, dry age-related macular degeneration.
Primary Objective: To test the safety and tolerability of CPCB-RPE1 during and after subretinal implantation in patients with geographic atrophy with evidence of involvement of the central fovea.
Secondary Objective: To assess visual acuity, visual field, and retinal function after CPCB-RPE1 implantation. Implanted and fellow eyes will be compared post-implantation to assess the ability of the implant to prevent disease progression.
Who can participate?
Females and Males diagnosed with advanced Dry Age-related Macular Degeneration
Ages 55-85 years
Severe vision loss due to Dry AMD in at least one of the eyes
Willing to have a surgical procedure to replace damage and lost cells in the retina
Willing to undergo diagnostic testing after surgery to monitor the response of the retina