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NCT Number: NCT07368959

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

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.

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Key information

Conditions

Corneal Edema Corneal Diseases Corneal Endothelial Dysfunction Eye Diseases Fuchs Endothelial Corneal Dysfunction Pseudophakic Bullous Keratopathy (PBK)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site 2, Mesa, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6

    Time frame: Baseline (Day 1) and At Month 6

  2. Change from baseline in BCVA at Month 6

    Time frame: Baseline (Day 1) and At Month 6

Study contacts

Contact information is provided by the study sponsor or research team.

Aurion Study Team

CONTACT

[email protected]

1-857-639-4163

Sponsors and collaborators

Lead sponsor

Aurion Biotech

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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