Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Status: | Suspended |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - 90 |
Updated: | 4/21/2016 |
Start Date: | June 2015 |
End Date: | December 2017 |
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
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.
bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with
bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will
be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and
safety for 12 months. An independent data monitoring committee (IDMC) will review adverse
events for the duration of the study.
bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will
be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and
safety for 12 months. An independent data monitoring committee (IDMC) will review adverse
events for the duration of the study.
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
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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