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

NCT02653391 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-09-17

Study results available
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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.

Conditions

  • Fuchs' Corneal Endothelial Dystrophy (FCED)

Interventions

DRUG

Part A Elamipretide 1.0% Ophthalmic Solution

Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye.

DRUG

Part B Elamipretide 3.0% Ophthalmic Solution

Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both eyes.

DRUG

Part A Placebo

Part A Each subject will receive one drop of vehicle ophthalmic solution BID in the paired eye of the randomly selected study eye.

DRUG

Part B Placebo

Part B: Each subject will receive one drop of vehicle ophthalmic solution BID in both eyes.

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Raizman, MD · Ophthalmic Consultants of Boston

  • Edward Holland, MD · Cincinnati Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-03-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653391 on ClinicalTrials.gov