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NCT06041256 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
A Phase 1 study, sponsored by Aurion Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT06041256: Completed Phase 1 study, sponsored by Aurion Biotech.
NCT06041256 is a Phase 1 study that has completed, run by Aurion Biotech. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041256, a Phase 1 study, has completed, sponsored by Aurion Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study 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.
Primary Outcome
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to
Interventions
- COMBINATION_PRODUCT AURN001
- BIOLOGICAL Corneal Endothelial Cells
- DRUG Y27632
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2025-04-15 |
| Phase | Phase 1 |
What the finished NCT06041256 record still lists
NCT06041256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 3 interventions - of which AURN001 is the first listed.
NCT06041256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06041256 about?
NCT06041256 is a clinical study titled "A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)". 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. ...
What is the current status of trial NCT06041256?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2023-10-18. Estimated completion is 2025-04-15.
What interventions are being tested in trial NCT06041256?
The interventions under investigation include: AURN001 (COMBINATION_PRODUCT), Corneal Endothelial Cells (BIOLOGICAL), Y27632 (DRUG).
Who is sponsoring clinical trial NCT06041256?
This trial is sponsored by Aurion Biotech, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06041256's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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