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New eye injection could restore sight in corneal swelling patients

NCT ID NCT07368959

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single injection of AURN001 in 120 adults with corneal swelling caused by endothelial dysfunction. The goal is to see if it improves vision and reduces corneal thickness compared to a placebo. Participants must already have an artificial lens in the eye and be candidates for corneal transplant surgery.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

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 years and older

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.

Key Ocular Inclusion Criteria: (All ocular criteria apply to the study eye unless noted otherwise) * Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty) * BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent) * Be pseudophakic with PCIOL Key Ocular Exclusion Criteria: (All ocular criteria apply to the study eye unless noted otherwise) * Have progressive corneal dystrophies or degenerations * Have visually significant corneal or other ocular pathologies Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigational Site 1

    RECRUITING

    Spring, Texas, 77388, United States

  • Investigational Site 10

    RECRUITING

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Investigational Site 11

    RECRUITING

    Leland, North Carolina, 28451, United States

  • Investigational Site 12

    RECRUITING

    Ladson, South Carolina, 29456, United States

  • Investigational Site 2

    RECRUITING

    Mesa, Arizona, 85206, United States

  • Investigational Site 3

    RECRUITING

    Cynwyd, Pennsylvania, 19004, United States

  • Investigational Site 4

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • Investigational Site 5

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Investigational Site 6

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Investigational Site 7

    RECRUITING

    Atlanta, Georgia, 30339, United States

  • Investigational Site 8

    RECRUITING

    San Antonio, Texas, 78209, United States

  • Investigational Site 9

    RECRUITING

    Fort Collins, Colorado, 80528, United States

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