Peptide Library

Human study PLS-00228

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

Other design · 22 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)registry entry · NCT02653391 (COMPLETED, results posted, planned enrollment 22)

Design and participants

Design
Other design
Population
People with Fuchs' corneal endothelial dystrophy (FCED).
Conditions
Fuchs' Corneal Endothelial Dystrophy (FCED)
Planned enrollment (registry)
22
Enrolled
22
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • Part A elamipretide (intervention) · elamipretide (formulation) · Elamipretide (MTP-131, Bendavia) topical ophthalmic solution, Part A · topical ophthalmic · Not reported assigned
  • Part A placebo (comparator) · Placebo, Part A · placebo · topical ophthalmic · Not reported assigned
  • Part B elamipretide (intervention) · elamipretide (formulation) · Elamipretide (MTP-131, Bendavia) topical ophthalmic solution, Part B · topical ophthalmic · Not reported assigned
  • Part B placebo (comparator) · Placebo, Part B · placebo · topical ophthalmic · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Safety and tolerability

unclear outcome · safety

  • No results reported.

Adverse events

None reported. That is not evidence of safety, and how safety was monitored isn’t described.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • abstract only: Only a ClinicalTrials.gov registration entry is available. There is no publication, abstract or results data in the record.
  • small or imprecise: The registry reports an actual enrollment of only 22 participants, split across four arms in two parts.
  • other: The record lists placebo arms but does not state whether allocation was randomized, so the design cannot be confirmed as an RCT.
  • selective reporting: The registry flags that results exist, but no outcome measures or results are provided in the record.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

  • Insufficient information to assess Adverse events, including injection-site reactions, and discontinuations

Where each value comes from

  • arms: NCT NCT02653391, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT02653391, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT02653391, registry (has_results and enrollment fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT02653391, title (study title) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT02653391, registry (enrollment field (actual)) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT02653391, registry (conditions field) · extracted by AI (automated, not verified by a person)

  • Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).