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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: Completed Phase 1 study, sponsored by Stealth BioTherapeutics.
NCT02653391 is a Phase 1 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The incidence and severity of ocular treatment emergent adverse events (TEAEs)
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 |
What the finished NCT02653391 record still lists
NCT02653391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which Part A Elamipretide 1.0% Ophthalmic Solution is the first listed.
NCT02653391 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02653391's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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