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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07368959

Enrollment

120

Registered

2026-01-27

Start date

2026-02-19

Completion date

2028-01-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK)

Keywords

Best Corrected Visual Acuity, Central corneal thickness, Human Corneal Endothelial Cells, Neltependocel, Postsurgical endothelial dysfunction, Keratoplasty, Pseudophakic Corneal Edema (PCE), Corneal Endothelial Cells, Endothelial Cells, AURN001, Y-27632, Endothelial Keratoplasty, Corneal Endothelial Cell Therapy

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

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	At Month 6

Secondary

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

Countries

United States

Contacts

CONTACTAurion Study Team

ASTRA@aurionbiotech.com1-857-639-4163

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026