Geographic Atrophy Clinical Trial
Official title:
A Phase I/IIa Safety Study of Subretinal Implantation of CPCB-RPE1 (Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells Seeded on a Polymeric Substrate) in Subjects With Advanced, Dry Age-Related Macular Degeneration (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.
Exploratory Objectives:
• To assess the feasibility of measuring the change in area of geographic atrophy over time
using spectral domain optical coherence tomography or fundus autofluorescence.
The study will include two cohorts, each of 10 patients. For the first cohort, the study
population will be patients with advanced, dry AMD with evidence of significant geographic
atrophy involving the fovea. These patients will have significant central vision loss with
best-corrected visual acuity (BCVA) of the eye to be implanted of BCVA of 20/200 or worse.
Each of these patients will have substantial RPE and photoreceptor loss. Patients will be
screened for overall health status to minimize risks associated with retinal surgery and any
subsequent immunosuppression.
As the safety and tolerability of CPCB-RPE1 is demonstrated in the first cohort, patients
with less advanced disease will be recruited into a second cohort in this Phase I/IIa
clinical trial. In this second cohort patients will have significant central vision loss with
BCVA of the eye to be implanted of 20/80 or worse, but better than or equal to 20/400 with
comparably less damage to the RPE/photoreceptor complex than Cohort 1. These patients will be
screened in the same manner for overall health status to minimize risks associated with
retinal surgery and any subsequent immunosuppression. Assessments of visual function will be
the same as in Cohort 1.
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