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

September 23, 2026 updated by: Aurion Biotech

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Investigational Site 2
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site 6
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Investigational Site 9
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Investigational Site 7
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Investigational Site 4
    • North Carolina
      • Leland, North Carolina, United States, 28451
        • Investigational Site 11
      • Winston-Salem, North Carolina, United States, 27157
        • Investigational Site 5
    • Pennsylvania
      • Cynwyd, Pennsylvania, United States, 19004
        • Investigational Site 3
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Investigational Site 10
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Investigational Site 12
    • Texas
      • San Antonio, Texas, United States, 78209
        • Investigational Site 8
      • Spring, Texas, United States, 77388
        • Investigational Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Ocular Inclusion Criteria:

(All ocular criteria apply to the study eye unless noted otherwise)

  • 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

Key Ocular Exclusion Criteria:

(All ocular criteria apply to the study eye unless noted otherwise)

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

Other inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AURN001

Participants will receive single dose of AURN001
Drug: Combination Product: AURN001 + Y-27632

AURN001 will be injected to the anterior chamber of the eye.
Placebo Comparator: Placebo

Participants will receive single dose of placebo control.
Other: Placebo

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6
Time Frame: Baseline (Day 1) and At Month 6
Baseline (Day 1) and At Month 6
Change from baseline in BCVA at Month 6
Time Frame: Baseline (Day 1) and At Month 6
Baseline (Day 1) and At Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurion Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

September 24, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABA-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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