AURN001 for Corneal Edema

(CLARA Trial)

Not currently recruiting at 18 trial locations

Overseen By Study Manager, OD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Aurion Biotech

Disqualifiers: Ocular disease, Corneal scarring, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of AURN001, an experimental treatment for corneal edema. This condition causes swelling in the eye's clear front part due to issues with the inner cell layer. The trial compares different doses of AURN001 to determine which best reduces swelling. Participants receive a single injection, and researchers compare AURN001 with its individual components to understand their effects. This trial suits those with corneal edema from endothelial dysfunction who are considering eye surgery. As a Phase 1/Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

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 this trial's treatments are likely to be safe?

Research has shown that AURN001, also known as Neltependocel, is generally safe based on previous studies. In one study, people with corneal edema (swelling of the cornea) handled the treatment well, with most patients not experiencing serious side effects.

Researchers tested the treatment in different doses—low, medium, and high—and all were well-tolerated. Some people experienced mild side effects, like temporary eye discomfort, but these were not serious.

Another study confirmed these results, showing no major negative effects from the treatment. This suggests that AURN001 is a safe option for those with corneal edema. However, as with any new treatment, monitoring for side effects remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for corneal edema, which typically involve hypertonic saline or surgical procedures like corneal transplantation, AURN001 targets the condition at a cellular level. This treatment combines Neltependocel with Rho-associated protein kinase (ROCK) to help reduce fluid buildup and improve corneal clarity. Researchers are excited because this approach could offer a less invasive and more effective solution for managing corneal edema, potentially speeding up recovery and improving vision without the need for surgery.

What evidence suggests that this trial's treatments could be effective for corneal edema?

Research shows that AURN001 may help treat corneal swelling caused by issues with the cornea's inner layer. This trial will administer different doses of AURN001—low, medium, and high—to evaluate its effectiveness. In earlier studies, patients who received high doses of AURN001 experienced much better vision. Specifically, 65% of these patients could read 15 or more extra letters on an eye chart, marking a significant improvement. The treatment uses donor cells to repair damaged corneal tissue. Results indicated that higher doses led to better outcomes, suggesting that AURN001 could be a promising option for improving vision in people with this type of corneal swelling. ^{1 2 6 7 8}

Who Is on the Research Team?

Study Manager, OD

Principal Investigator

Aurion Biotech

Are You a Good Fit for This Trial?

This trial is for people with corneal edema due to endothelial dysfunction needing surgery, with vision levels between approximately 20/50 and 20/800 Snellen equivalent. It's not for those with significant scarring or other eye diseases affecting vision besides endothelial dysfunction.

Inclusion Criteria

I need surgery for swelling in my eye due to a cornea problem.

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

I have significant scarring or cloudiness in the center of my eye that could improve with treatment.

I have an eye condition that could affect my vision or safety assessments, other than corneal endothelial dysfunction.

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 of AURN001 at varying doses to assess safety and efficacy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AURN001

Trial Overview The study tests different doses of AURN001 in patients with corneal swelling from endothelial dysfunction. Participants will get a single injection to see which dose is safe and effective at reducing the swelling.

How Is the Trial Designed?

Group I: ROCK Experimental Treatment 1 Intervention

Rho-associated protein kinase (ROCK)

Group II: Neltependocel - High Experimental Treatment 1 Intervention

Neltependocel - High

Group III: AURN001 Medium Experimental Treatment 1 Intervention

Neltependocel Medium and Rho-associated protein kinase

Group IV: AURN001 Low Experimental Treatment 1 Intervention

Neltependocel Low and Rho-associated protein kinase

Group V: AURN001 High Experimental Treatment 1 Intervention

Neltependocel High and Rho-associated protein kinase

Who Is Running the Clinical Trial?

Aurion Biotech

Lead Sponsor

Trials

3

Recruited

150+

Citations

1. aurionbiotech.com aurionbiotech.com/aurion-biotech-announces-positive-data-for-phase_1-2_trial/

Aurion Biotech Announces Positive Topline Data for Phase ... Aurion Biotech is advancing AURN001, an investigational single administration, allogeneic cell therapy to treat corneal edema secondary to ...

2. ophthalmologytimes.com ophthalmologytimes.com/view/aurion-biotech-releases-positive-12-month-results-from-phase-1-2-clara-trial

Aurion Biotech releases positive 12-month results from ... AURN001 demonstrated a dose-dependent response, with the high-dose group achieving significant visual acuity improvements and a mean BCVA change ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06041256

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.

4. eyewire.news eyewire.news/news/aurion-announces-positive-12-month-results-from-phase-12-clara-trial-of-aurn001-corneal-endothelial-cell-therapy

Aurion Announces Positive 12-Month Results from Phase 1 ... At 12 months, 65% of subjects in the high-dose AURN001 group—compared to 0% in the Y-27632 control group—achieved a ≥15-letter gain in best ...

5. firstwordpharma.com firstwordpharma.com/story/6325223

Aurion Biotech Achieves All Primary, Secondary, and ... Data strongly supports advancing high dose AURN001 regenerative cell therapy for patients with corneal endothelial disease to pivotal Phase ...

6. cgtlive.com cgtlive.com/view/aurion-biotech-cell-therapy-aurn001-demonstrates-efficacy-safety-phase-aba-clara-clinical-trial

Aurion Biotech's Cell Therapy AURN001 Demonstrates ... The trial is evaluating AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction.

7. aurionbiotech.com aurionbiotech.com/products/

Corneal Endothelial Cell Therapy AURN001; Indication: Corneal edema secondary to corneal endothelial dysfunction; Phase: Phase 3 (U.S.) *; Next Anticipated Milestone: Twelve-month topline ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06041256?term=aurion&rank=2

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. The ...