AURN001 for Corneal Edema

Not yet recruiting at 11 trial locations
AS
Overseen ByAurion Study Team
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Aurion Biotech
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AURN001, an experimental therapy, to determine its safety and effectiveness for individuals with corneal edema. This condition causes eye swelling due to corneal endothelial dysfunction. Participants will receive either a single injection of AURN001 or a placebo for comparison. The trial seeks individuals with corneal edema severe enough to require surgery and who have an artificial lens implant. The study aims to determine if AURN001 can reduce eye swelling and improve vision. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AURN001 is likely to be safe for humans?

Research has shown that AURN001 is generally safe based on past studies. In these trials, many patients with corneal edema (swelling in the eye's cornea) tolerated AURN001 well. The studies did not find any serious safety issues. Some mild side effects occurred, but they were uncommon. This evidence suggests that AURN001 is generally safe for people with corneal edema due to corneal endothelial dysfunction.12345

Why do researchers think this study treatment might be promising?

AURN001 is unique because it offers a new approach to treating corneal edema. Unlike existing treatments, which often include hypertonic saline ointments or drops to reduce swelling, AURN001 is designed to work differently by potentially targeting underlying cellular mechanisms that contribute to the condition. Researchers are excited about AURN001 because it could provide faster relief and longer-lasting results, improving patient comfort and vision more effectively than current options.

What evidence suggests that AURN001 might be an effective treatment for corneal edema?

Research has shown that AURN001 holds promise for treating corneal edema, a condition where the cornea swells due to excess fluid. In earlier studies, patients who received a high dose of AURN001 improved their vision by an average of 12.5 letters on an eye chart. These patients also experienced a reduction in corneal thickness by 23.2 micrometers, which helps clear vision. The treatment significantly improved both vision and quality of life for individuals with corneal endothelial dysfunction. In this trial, participants will receive either a single dose of AURN001 or a placebo control. These findings suggest that AURN001 could effectively treat corneal edema.45678

Are You a Good Fit for This Trial?

This trial is for adults with corneal edema due to endothelial dysfunction, such as Fuchs' dystrophy or PBK. Participants must have a specific level of vision impairment and corneal thickness. Those with recent eye surgery, active eye infection, or other conditions affecting the study outcome cannot join.

Inclusion Criteria

I need surgery for swelling in my eye caused by a specific type of cornea problem.
Best-corrected visual acuity (BCVA) between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)
Be pseudophakic with posterior chamber intraocular lens (PCIOL)

Exclusion Criteria

My eye condition is getting worse over time.
I have eye conditions that significantly affect my vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection dose of AURN001 or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • AURN001

Trial Overview

The trial is testing AURN001 combined with Y-27632 against a placebo in treating corneal edema from endothelial dysfunction. It's designed to see if a single injection dose can improve the condition compared to no active treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: AURN001Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aurion Biotech

Lead Sponsor

Trials
3
Recruited
150+

Citations

Aurion Biotech releases positive 12-month results from ...

The trial evaluated the safety, efficacy, and tolerability of AURN001 in patients with corneal edema secondary to corneal endothelial ...

Data strongly supports advancing high dose AURN001 ...

Data strongly supports advancing high dose AURN001 regenerative cell therapy for patients with corneal endothelial disease to pivotal Phase 3 trial in H1 2026.

AURN001 improves visual acuity at 12 months in phase ...

The mean change in BCVA from baseline was 12.5 letters in the high-dose group, with a mean reduction in central corneal thickness of 23.2 µm, ...

Aurion Announces Positive Topline Data for Phase 1/2 ...

A key secondary endpoint, change in BCVA at 6 months, showed a statistically significant improvement for the high-dose AURN001 arm (P=0.002), as ...

AURN001 Achieves Dose-Dependent Response at 6 ...

A Phase 1/2 trial shows promising results for corneal edema, highlighting significant visual and quality of life improvements with an innovative cell therapy.

Aurion Biotech Announces Positive Topline Data for Phase ...

... safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. Ninety-seven ...

A Phase 1/2 Study of AURN001 in Subjects With Corneal ...

The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction.

Aurion Biotech's Cell Therapy AURN001 Demonstrates ...

The trial is evaluating AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction.