drugset / Trial / NCT02653391

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

NCT02653391

Phase 1/2 Completed 22 enrolled Stealth BioTherapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 1/2 prospective, randomized, double-masked, and vehicle-controlled trial in two parts to evaluate the safety, tolerability, and efficacy of elamipretide topical ophthalmic solution in patients with Fuchs' Corneal Endothelial Dystrophy (FCED) presenting with mild to moderate corneal edema.

Timeline

Start
2016-02
Primary completion
2018-03
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Elamipretide Peptide 1 % Topical
Subject Elamipretide Peptide 3 % Topical