Clinical trial NCT04520321
Conditions: Corneal Endothelial Dystrophy Fuchs Endothelial Corneal Dystrophy Pseudophakic Bullous Keratopathy Endothelial Dysfunction
Sponsor: Trefoil Therapeutics, Inc.
Start date: 2020-08-19; Completion date: 2021-05-18
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study

Detailed description:
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.

Arms: arm 1: Placebo weekly x 4 arm 2: TTHX1114(NM141) low-dose weekly x 4 arm 3: TTHX1114(NM141) mid-dose weekly x 4 arm 4: TTHX1114(NM141) high-dose weekly x 4
Interventions: intervention 1: TTHX1114(NM141) intervention 2: Vehicle (placebo)
Intervention descriptions: intervention 1: engineered FGF-1 delivered intracamerally intervention 2: Placebo

Protocol documents:
Prot_001.pdf: 
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