Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Trial ID or NCT#
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.
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
- - 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
- - 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
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