What is the mechanism of action of this treatment?

Common treatments for corneal edema, particularly those targeting corneal endothelial dysfunction like AURN001, involve cell therapy and Rho kinase inhibitors such as Y27632. Cell therapy aims to replace or repair damaged endothelial cells, which are essential for maintaining corneal transparency by regulating fluid balance. Y27632 enhances this process by promoting wound healing and cell proliferation. This combination therapy is crucial for corneal edema patients as it directly addresses the underlying endothelial dysfunction, potentially providing a more effective and durable treatment compared to traditional methods.

What side effects are associated with this type of intervention?

Common treatments for corneal edema, particularly those targeting corneal endothelial dysfunction like the combination therapy in the AURN001 trial, include Y27632 (a ROCK inhibitor) and cell-based therapies. Y27632 has shown promise in improving corneal clarity and promoting endothelial wound healing, but potential side effects may include mild ocular irritation. Cell-based therapies, while still under investigation, may carry risks of immune reactions or graft rejection. Hypertonic solutions, another common treatment, can cause temporary stinging or burning sensations. Overall, these treatments are generally well-tolerated, but close monitoring by an ophthalmologist is recommended to manage any adverse effects.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments that combine cell therapy and ROCK inhibitors like Y27632 for corneal edema secondary to corneal endothelial dysfunction. However, ROCK inhibitors have shown promise in clinical studies for improving corneal endothelial wound healing and reducing corneal edema. Other treatments for corneal edema include hypertonic saline solutions and various anti-inflammatory medications, but these do not specifically target endothelial dysfunction in the same way as the combination therapy being studied in the AURN001 trial.

What other types of research exist?

Promising novel alternatives to AURN001 for treating corneal edema in 2024 include tissue-engineered constructs, novel corneal endothelial cell therapies, SKPs-derived corneal endothelial cell-like cells, and pharmaceutical agents such as nicotinamide.

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AURN001 for Corneal Edema (CLARA Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Aurion Biotech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)

Be older than 18 years old

Must not have

Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new injection called AURN001 to help people with corneal swelling due to inner cornea problems. It aims to find out if AURN001 is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, potential risks may include typical reactions to injections like discomfort, redness, inflammation at the site of injection, and possible impact on vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BCVA - 15-letter improvement (3-line gain)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: ROCKExperimental Treatment1 Intervention

Rho-associated protein kinase (ROCK)

Group II: Neltependocel - HighExperimental Treatment1 Intervention

Neltependocel - High

Group III: AURN001 MediumExperimental Treatment1 Intervention

Neltependocel Medium and Rho-associated protein kinase

Group IV: AURN001 LowExperimental Treatment1 Intervention

Neltependocel Low and Rho-associated protein kinase

Group V: AURN001 HighExperimental Treatment1 Intervention

Neltependocel High and Rho-associated protein kinase

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for corneal edema, particularly those targeting corneal endothelial dysfunction like AURN001, involve cell therapy and Rho kinase inhibitors such as Y27632. Cell therapy aims to replace or repair damaged endothelial cells, which are essential for maintaining corneal transparency by regulating fluid balance. Y27632 enhances this process by promoting wound healing and cell proliferation. This combination therapy is crucial for corneal edema patients as it directly addresses the underlying endothelial dysfunction, potentially providing a more effective and durable treatment compared to traditional methods.

Long-Term Observation and Sequencing Analysis of SKPs-Derived Corneal Endothelial Cell-Like Cells for Treating Corneal Endothelial Dysfunction.Corneal Endothelial Cells Over the Past Decade: Are We Missing the Mark(er)?A Rabbit Corneal Endothelial Dysfunction Model Using Endothelial-Mesenchymal Transformed Cells.