NCT07368959 AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
| NCT ID | NCT07368959 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Aurion Biotech |
| Condition | Corneal Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2026-02-19 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07368959 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Corneal Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07368959 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT07368959 currently recruiting?
Yes, NCT07368959 is actively recruiting participants. Contact the research team at ASTRA@aurionbiotech.com for enrollment information.
Where is the NCT07368959 trial being conducted?
This trial is being conducted at Mesa, United States, Little Rock, United States, Fort Collins, United States, Atlanta, United States and 8 additional locations.
Who is sponsoring the NCT07368959 clinical trial?
NCT07368959 is sponsored by Aurion Biotech. The trial plans to enroll 120 participants.