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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Enrollment target: estimated 120 to confirmed 130
    • Site details revised at 12 of 12 sites
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv5
  3. Site details revised at 1 of 12 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2026 to Feb 19, 2026
    • Site details revised at 12 of 12 sites
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07368959
Lead Sponsor Aurion Biotech
Conditions
(from sponsor)		 Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK)
Related terms Corneal Edema
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov