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Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Trial ID: NCT02467634
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
- 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
biological: HuCNS-SC sub-retinal transplantation
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