Macular Degeneration Clinical Trial
Official title:
Phase I/II Study of the Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to age-related macular degeneration.
This study is an open-label dose-escalation investigation of the safety and preliminary
efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with
Geographic Atrophy secondary to Age-Related Macular Degeneration (AMD). Subjects will be
enrolled based on specific inclusion/exclusion criteria and evaluated at regular post
transplant intervals. The investigation will be divided into two sequential cohorts.
Subjects will be enrolled into each cohort based on best-corrected visual acuity (BCVA)
visual acuity as determined by the Electronic Early Treatment Diabetic Retinopathy Study
(E-ETDRS) acuity test. BCVA of less than or equal to 20/400 in the Study Eye will be
enrolled in Cohort I. Subjects with BCVA of 20/320 to 20/100 in the Study Eye will be
enrolled in Cohort II. Cohort I will consist of four subjects who will undergo transplant
with 200,000 cells followed by four subjects who will undergo transplant with 1 million
cells. Cohort II will consist of 7 subjects who will undergo transplant with 1 million
cells. An independent Data Monitoring Committee (DMC) will review accruing safety data for
all subjects.
HuCNS-SC cells will be transplanted by a board-certified vitreoretinal surgeon. The
transplantation will be conducted in the eye with the inferior best-corrected visual acuity
(BCVA) (i.e., the Study Eye). Only the Study Eye will undergo transplantation. The HuCNS-SC
cells will be administered into the subretinal space through a standard surgical approach.
Immunosuppressive agents will be administered orally to all subjects for a period of three
months after surgery.
Subjects will be monitored frequently for a total of one year after HuCNS-SC cell
transplantation. An additional four years of monitoring will be conducted in a separate
follow-up study that will commence with the termination visit of the Phase I/II
investigation. The follow-up study will be conducted as a separate investigation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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