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

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
12
sites
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Campbell, California 95008
?
mi
from
Campbell, CA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Mountain View, California 94040
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
Palo Alto, California 94303
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials