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RecruitingPhase 3NCT07368959

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

ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)

Sponsor

Aurion Biotech

Enrollment

120 participants

Start Date

Feb 19, 2026

Study Type

INTERVENTIONAL

Conditions

Corneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous Keratopathy (PBK)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Combination Product: AURN001 + Y-27632 and Placebo for people with corneal edema, corneal endothelial dysfunction, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombination Product: AURN001 + Y-27632

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

OTHERPlacebo

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

Locations(12)

Investigational Site 2

Mesa, Arizona, United States

Investigational Site 6

Little Rock, Arkansas, United States

Investigational Site 9

Fort Collins, Colorado, United States

Investigational Site 7

Atlanta, Georgia, United States

Investigational Site 4

Kansas City, Missouri, United States

Investigational Site 11

Leland, North Carolina, United States

Investigational Site 5

Winston-Salem, North Carolina, United States

Investigational Site 3

Cynwyd, Pennsylvania, United States

Investigational Site 10

Plymouth Meeting, Pennsylvania, United States

Investigational Site 12

Ladson, South Carolina, United States

Investigational Site 8

San Antonio, Texas, United States

Investigational Site 1

Spring, Texas, United States

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NCT07368959

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