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NCT02653391 · ClinicalTrials.gov registry record · Phase 1
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)
A Phase 1 study, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02653391 is a Phase 1 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 22 participants.
The verdict
NCT02653391, a Phase 1 study, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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.
Interventions
- DRUG Part A Elamipretide 1.0% Ophthalmic Solution
- DRUG Part B Elamipretide 3.0% Ophthalmic Solution
- DRUG Part A Placebo
- DRUG Part B Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02653391
The ClinicalTrials.gov registry entry for NCT02653391 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Part A Elamipretide 1.0% Ophthalmic Solution is the first listed.
NCT02653391 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02653391 about?
NCT02653391 is a clinical study titled "A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)". 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 e...
What is the current status of trial NCT02653391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2016-02. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02653391?
The interventions under investigation include: Part A Elamipretide 1.0% Ophthalmic Solution (DRUG), Part B Elamipretide 3.0% Ophthalmic Solution (DRUG), Part A Placebo (DRUG), Part B Placebo (DRUG).
Who is sponsoring clinical trial NCT02653391?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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