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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elamipretide | Peptide | 1 % | Topical |
| Subject | Elamipretide | Peptide | 3 % | Topical |