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Eye injection could replace corneal transplants for swelling

NCT ID NCT06041256

Disease control Sponsor: Aurion Biotech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This clinical trial tested a new treatment called AURN001 for people with corneal edema, a condition where the cornea swells due to damaged cells. The treatment is a single injection into the eye that combines donor corneal cells with a drug to help them work. The study involved 97 participants and compared different doses to see if it safely improves vision. The goal is to offer an alternative to corneal transplant surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AURN001 (a combination of corneal endothelial cells and Y27632 drug)
What this could lead to
If successful, this could lead to a non-surgical injection treatment for corneal edema, potentially replacing or delaying the need for corneal transplant surgery.
What could go wrong
This is an early-phase trial (phase 1/2) with only 97 participants, so results may not apply to everyone. The treatment is still experimental, and long-term safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

97 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty) * 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: * Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye * Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments

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Conditions

The condition(s) this trial relates to.

corneal edema secondary corneal edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corneal edema Corneal endothelial dysfunction

Contacts and locations

Locations

  • Aurion Biotech site

    Little Rock, Arkansas, 72205, United States

  • Aurion Biotech site

    Los Angeles, California, 90067, United States

  • Aurion Biotech site

    San Francisco, California, 94158, United States

  • Aurion Biotech site

    Atlanta, Georgia, 30339, United States

  • Aurion Biotech site

    Indianapolis, Indiana, 46260, United States

  • Aurion Biotech site

    Wichita, Kansas, 67206, United States

  • Aurion Biotech site

    Minnetonka, Minnesota, 55305, United States

  • Aurion Biotech site

    Garden City, New York, 11576, United States

  • Aurion Biotech site

    Winston-Salem, North Carolina, 27157, United States

  • Aurion Biotech site

    Cincinnati, Ohio, 45242, United States

  • Aurion Biotech site

    Oklahoma City, Oklahoma, 73104, United States

  • Aurion Biotech site

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Aurion Biotech site

    Sioux Falls, South Dakota, 57108, United States

  • Aurion Biotech site

    Houston, Texas, 77027, United States

  • Aurion Biotech site

    Houston, Texas, 77055, United States

  • Aurion Biotech site

    Norfolk, Virginia, 23502, United States

  • Aurion Biotech site

    Seattle, Washington, 98125, United States

  • Aurion Biotech site

    Vancouver, British Columbia, V5Z 1K1 CAN, Canada

  • Aurion Biotech site

    Oakville, Ontario, L6H 0J8 CAN, Canada

  • Aurion Biotech site

    Toronto, Ontario, M5T 3A9 CAN, Canada

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