Health Trials

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

ConditionsCorneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous Keratopathy (PBK)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAurion Biotech

About this trial

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.

Eligibility criteria

Qualifiers

Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)

BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)

Be pseudophakic with PCIOL

Disqualifiers

Have progressive corneal dystrophies or degenerations

Have visually significant corneal or other ocular pathologies

Trial design

Treatments tested in this trial

  • Combination Product: AURN001 + Y-27632
  • Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Aurion Biotech

Lead sponsor

Source ClinicalTrials.gov