Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Trial ID or NCT#
NCT02467634
Status
NOT RECRUITING
Purpose
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
Official Title
A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
Eligibility Criteria
Ages Eligible for Study: 50 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence. - BCVA of 20/320 or better in each eye at screening assessment
Exclusion Criteria:
- - Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center. - Retinal or macular disease of any other cause in either eye. - Diagnosis of glaucoma in either eye. - Uncontrolled intraocular pressure in either eye - Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection. - History of or active autoimmune disease. - Previous organ, tissue or bone marrow transplantation. - Seropositive for HIV, hepatitis B or C, or CMV IgM
Investigator(s)
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
View on ClinicalTrials.gov
