Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

Trial ID or NCT#

NCT02467634

Status

not recruiting iconNOT 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:
  1. * 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:
  1. * 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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Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)

View on ClinicalTrials.gov