AURN001 for Corneal Edema

(CLARA Trial)

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment AURN001 for corneal edema?

Research shows that hyperosmolar eye drops, similar to AURN001, have been effective in reducing corneal swelling and improving vision in patients with corneal edema. ^{1 2 3 4 5}

What safety data exists for AURN001 or similar treatments?

Triamcinolone acetonide, which may be similar to AURN001, has been studied for safety in eye treatments. Some studies show it is generally safe for use in the eye, but the vehicle (substance used to deliver the drug) can be toxic to eye tissues in animals. ^{6 7 8 9 10}

Research Team

Study Manager, OD

Principal Investigator

Aurion Biotech

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Hyperosmolar Eye Drops for Diurnal Corneal Edema in Fuchs' Endothelial Dystrophy: A Double-Masked, Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of fenestrating soft contact lenses on corneal swelling: a re-examination. [2015]

3. France pubmed.ncbi.nlm.nih.gov

[Visual acuity, pachymetry and corneal density after 5% sodium chloride treatment in corneal edema after surgery]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Hypertonic saline solution in corneal edema. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Refractive stabilization and corneal swelling after cataract surgery. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Further characterization of ocular safety profile of commercially available preserved and preservative-free triamcinolone acetonide. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Less Invasive Corneal Transepithelial Electrical Resistance Measurement Method. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA). [2022]

9. England pubmed.ncbi.nlm.nih.gov

Vehicle used for triamcinolone acetonide is toxic to ocular tissues of the pigmented rabbit. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Visually significant cystoid macular edema in pseudophakic and aphakic patients with glaucoma receiving latanoprost. [2019]