Home › Trials › NCT07368959

Single injection of AURN001 for corneal edema from 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)

Phase 3 Interventional Aurion Biotech · NCT07368959

This tests whether one injection of AURN001 can reduce corneal swelling and improve vision in adults with corneal edema due to endothelial dysfunction who are pseudophakic and considered for endothelial keratoplasty.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorAurion Biotech Industry-sponsored
Locations12 sites (Mesa, Arizona and 11 other locations)
Trial IDNCT07368959 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares a single injection dose of AURN001 (human corneal endothelial cells combined with the ROCK inhibitor Y-27632) with placebo in adults who have corneal edema secondary to endothelial dysfunction. Eligible participants are pseudophakic, meet a specified range of best corrected visual acuity, and are considered to require endothelial keratoplasty. Participants receive a single administration of AURN001 or placebo and are followed for clinical outcomes and safety. Primary measures include best corrected visual acuity and central corneal thickness, along with monitoring for adverse events.

Who should consider this trial

Good fit: Adults with corneal edema from endothelial dysfunction who are pseudophakic, fall within the trial's visual acuity range, and are judged to need endothelial keratoplasty are the intended participants.

Not a fit: Patients with progressive corneal dystrophies, other visually significant ocular pathologies, or those who do not meet the pseudophakic or visual acuity requirements are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, AURN001 could reduce corneal swelling, improve vision, and potentially delay or avoid the need for endothelial keratoplasty.

How similar studies have performed: Early-phase studies of injected cultured corneal endothelial cells with ROCK inhibitors have shown promising results, but randomized Phase 3 evidence remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Mesa, Arizona and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Corneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous KeratopathyBest Corrected Visual AcuityCentral corneal thicknessHuman Corneal Endothelial CellsNeltependocel
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.