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AURN001 for Corneal Edema (CLARA Trial)

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

CLARA Trial Summary

This trial will compare different doses of a drug, AURN001, to see if it's safe and effective to treat corneal edema caused by corneal endothelial dysfunction. Participants get a single injection.

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.Check my eligibility

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.See study design

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.

CLARA Trial 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.

CLARA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

CLARA 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aurion BiotechLead Sponsor

1 Previous Clinical Trials

22 Total Patients Enrolled

1 Trials studying Corneal Edema

22 Patients Enrolled for Corneal Edema

Study Manager, ODStudy DirectorAurion Biotech

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to those below the age of 20?

"The parameters of this trial stipulate that potential participants must be between the ages of 18 and 99. Additionally, there are 94 studies specifically designed for elderly people over 65 years old and 9 specific to children below the age of 18."

Answered by AI

Are recruitment efforts currently underway for this trial?

"Correct. According to clinicaltrials.gov, this medical study is actively recruiting patients since its first listing on October 18th 2023 and most recently updated on the 25th of that same month. The research requires 100 participants from a single location."

Answered by AI

Are the criteria for this experiment compatible with my medical profile?

"This clinical trial is willing to accept participants who are aged 18-99 and suffer from corneal edema. There's a total cap of 100 patients for this study."

Answered by AI

How many individuals are being enrolled in this clinical research?

"Affirmative. Data accessible on clinicaltrials.gov confirms that this medical trial, initially advertised on October 18th 2023, is recruiting participants. Approximately 100 patients must be sourced from 1 medical location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

2023. "A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041256.

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