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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Aug 2017

At a glance

  • Drugs Elamipretide (Primary)
  • Indications Corneal disorders
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Stealth BioTherapeutics
  • Most Recent Events

    • 31 Jul 2017 Planned number of patients changed from 16 to 27.
    • 31 Jul 2017 Planned End Date changed from 1 Nov 2016 to 1 Mar 2018.
    • 31 Jul 2017 Planned primary completion date changed from 1 Nov 2016 to 1 Mar 2018.
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