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AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction

NCT07368959 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.

Conditions

  • Corneal Edema
  • Corneal Endothelial Dysfunction
  • Fuchs Endothelial Corneal Dysfunction
  • Pseudophakic Bullous Keratopathy (PBK)

Interventions

DRUG

Combination Product: AURN001 + Y-27632

AURN001 will be injected to the anterior chamber of the eye.

OTHER

Placebo

Placebo control will be injected to the anterior chamber of the eye.

Sponsors & Collaborators

  • Aurion Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-19
Primary Completion
2027-06-30
Completion
2028-01-31
FDA Drug
Yes

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 NCT07368959 on ClinicalTrials.gov