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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Combination Product: AURN001 + Y-27632 — DRUG
  AURN001 will be injected to the anterior chamber of the eye.
• Placebo — OTHER
  Placebo control will be injected to the anterior chamber of the eye.

Study Details

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.

Key Dates

Start date

Feb 19, 2026

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AURN001
  Participants will receive single dose of AURN001
• Placebo Comparator: Placebo
  Participants will receive single dose of placebo control.

Primary Outcome Measure

Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6 [ Time Frame: At Month 6 ]

Central Contacts

• Aurion Study Team
  1-857-639-4163
  [email protected]

Locations (12)

Find similar trials in Mesa, AZ

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