At a glance
ClinicalIndex Comparison Record- ✓Adults aged 18 years or older at screening
- ✓Diagnosis of FCED in both eyes based on clinical and ophthalmic test findings
- ✓Clinical evidence of corneal edema in both eyes with at least one sign: epithelial microcysts, epithelial bullae, stromal folds, or stromal haze
- ✓Central corneal thickness 550–700 μm (inclusive) in at least one eye measured by ultrasonic pachymetry at screening and baseline
- ✕Corneal findings (stromal haze, stromal scarring, etc.) that limit probability of visual improvement after deturgescence per investigator assessment
- ✕Ocular pathology requiring topical ophthalmic drops (except glaucoma or ocular hypertension)
- ✕Use of topical hypertonic saline drops for 3 days prior to screening or during study
- ✕History of corneal disease (other than FCED) or corneal surgery in either eye
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Part A: a Prospective, Randomized, Double-masked, Vehicle Controlled, Paired-eye Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Elamipretide Topical Ophthalmic Solution in Subjects With Fuchs' Corneal Endothelial Dystrophy (FCED) Presenting With Mild to Moderate Corneal Edema Part B: a Prospective, Randomized, Double-masked, Vehicle Controlled, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution in Subjects With FCED Presenting With Mild to Moderate Corneal Edema.
In Brief
A Phase 2 clinical trial evaluating Part A Elamipretide 1.0% Ophthalmic Solution, Part B Elamipretide 3.0% Ophthalmic Solution, and 2 other interventions for Fuchs' Corneal Endothelial Dystrophy (FCED). Completed, enrolled 22 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye.
Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both eyes.
Part A Each subject will receive one drop of vehicle ophthalmic solution BID in the paired eye of the randomly selected study eye.
Part B: Each subject will receive one drop of vehicle ophthalmic solution BID in both eyes.