Phase 2
N=97
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Corneal Edema · Corneal Endothelial Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT06041256 ↗Enrolled (actual)
97
Serious AEs
2.1%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data — 14.3; 44.4; 10.5; 36.8 Percentage of participants — p=0.0722
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AURN001 (Combination_product); Corneal Endothelial Cells (Biological); Y27632 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aurion Biotech
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data |
14.3; 44.4; 10.5; 36.8; 50.0 | 0.0722 |
| SECONDARY Change From Baseline in BCVA at Month 6 |
-25.5; -5.1; -15.7; -3.0; 10.4 | 0.0232 sig |
| SECONDARY Change From Baseline in Central Corneal Thickness (CCT) at Month 6 |
67.5; -7.6; -13.8; -5.6; -14.2 | 0.0147 sig |
| SECONDARY Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data |
4.8; 5.9; 10.5; 5.3; 10.0; 0 | — |
| SECONDARY Change From Baseline in BCVA at All Other Timepoints |
-28.7; -24.6; -27.8; -26.9; -16.9; -17.2 | — |
| SECONDARY Change From Baseline in CCT at All Other Timepoints |
87.4; 116.9; 93.4; 69.4; 117.0; 97.5 | — |
| SECONDARY Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data |
4.8; 11.8; 15.8; 5.3; 10.0; 0 | — |
Summary
The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
- BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)
Exclusion Criteria
- Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
- Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
Data sourced from ClinicalTrials.gov (NCT06041256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.