NCT04520321

A Phase 1/ Phase 2 Study of TTHX1114(NM141)

A Phase 1/ Phase 2 Study Evaluating the Safety and Efficacy of the Investigational New Drug TTHX1114(NM141) on the Regeneration of Corneal Endothelial Cells in Patients With Corneal Endothelial Dystrophies Following Intracameral Delivery

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Trefoil Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corneal Endothelial Dystrophy
• Fuchs Endothelial Corneal Dystrophy
• Pseudophakic Bullous Keratopathy
• Endothelial Dysfunction

Interventions

Type	Name	Description
DRUG	TTHX1114(NM141)	engineered FGF-1 delivered intracamerally
OTHER	Vehicle (placebo)	Placebo

Timeline

• Start date: 2020-08-19
• Primary completion: 2021-04-23
• Completion: 2021-05-18
• First posted: 2020-08-20
• Last updated: 2023-10-30
• Results posted: 2023-10-30

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study