Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07368959

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

Led by Aurion Biotech · Updated on 2026-04-08

120

Participants Needed

12

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have corneal edema secondary to corneal endothelial dysfunction requiring surgery (full- or partial-thickness endothelial keratoplasty)
  • Best Corrected Visual Acuity (BCVA) between 65 ETDRS letters (about 20/50) and 5 ETDRS letters (about 20/800)
  • Be pseudophakic with posterior chamber intraocular lens (PCIOL)
Not Eligible

You will not qualify if you...

  • Have progressive corneal dystrophies or degenerations
  • Have visually significant corneal or other ocular pathologies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Investigational Site 2

Mesa, Arizona, United States, 85206

Actively Recruiting

2

Investigational Site 6

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

Investigational Site 9

Fort Collins, Colorado, United States, 80528

Actively Recruiting

4

Investigational Site 7

Atlanta, Georgia, United States, 30339

Actively Recruiting

5

Investigational Site 4

Kansas City, Missouri, United States, 64154

Actively Recruiting

6

Investigational Site 11

Leland, North Carolina, United States, 28451

Actively Recruiting

7

Investigational Site 5

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

8

Investigational Site 3

Cynwyd, Pennsylvania, United States, 19004

Actively Recruiting

9

Investigational Site 10

Plymouth Meeting, Pennsylvania, United States, 19462

Actively Recruiting

10

Investigational Site 12

Ladson, South Carolina, United States, 29456

Actively Recruiting

11

Investigational Site 8

San Antonio, Texas, United States, 78209

Actively Recruiting

12

Investigational Site 1

Spring, Texas, United States, 77388

Actively Recruiting

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Research Team

A

Aurion Study Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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