Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
This is a prospective, multi-center, randomized, masked, vehicle-controlled, dose-escalation study that will include an observational (no intervention) sub-study. Eligible subjects with moderate to severe corneal endothelial dystrophy (defined as Endothelial Cell Density \< 2000 mm\^2) in at least one eye will be enrolled and randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
engineered FGF-1 delivered intracamerally
Placebo
North Bay Eye Associates, Inc.
Petaluma, California, United States
Levenson Eye Associates, Inc
Jacksonville, Florida, United States
Chicago Corneal Consultants
Hoffman Estates, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
DLTs/ Adverse Reactions
Suspected Adverse Reactions Reported Following Study Drug Adminsitration
Time frame: Day 90
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Tauber Eye Center
Kansas City, Missouri, United States
Vance Thompson Vision - Omaha
Omaha, Nebraska, United States
Alterman, Modi and Wolter
Poughkeepsie, New York, United States
Vance Thompson Vision - Sioux Falls
Sioux Falls, South Dakota, United States