AURN001 for Corneal Edema
(CLARA Trial)
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single injection of AURN001 at varying doses to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
5
Treatment groups
Experimental Treatment
Rho-associated protein kinase (ROCK)
Neltependocel - High
Neltependocel Medium and Rho-associated protein kinase
Neltependocel Low and Rho-associated protein kinase
Neltependocel High and Rho-associated protein kinase
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aurion Biotech
Lead Sponsor
Citations
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-trialAurion 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 ...
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 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 ...
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-trialAurion Biotech's Cell Therapy AURN001 Demonstrates ...
The trial is evaluating AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction.
Corneal Endothelial Cell Therapy
AURN001; Indication: Corneal edema secondary to corneal endothelial dysfunction; Phase: Phase 3 (U.S.) *; Next Anticipated Milestone: Twelve-month topline ...
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 ...
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