NCT07368959 · Aurion Biotech
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
What this study is about
The purpose of this study is to assess the effectiveness and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Mesa, Arizona
- Little Rock, Arkansas
- Fort Collins, Colorado
- Atlanta, Georgia
- Kansas City, Missouri
- Leland, North Carolina
- Winston-Salem, North Carolina
- Cynwyd, Pennsylvania
- Plymouth Meeting, Pennsylvania
- Ladson, South Carolina
- San Antonio, Texas
- Spring, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations