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Could steroids save sight in parasitic eye disease?

NCT ID NCT06213649

Disease control Sponsor: Jeremy Keenan, MD, MPH Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding steroid eye drops to standard anti-parasitic treatment improves vision in people with acanthamoeba keratitis, a rare but serious eye infection. About 232 participants who still have eye inflammation after one month of standard care will receive either steroid drops or placebo drops for several weeks. The main goal is to see if steroids help achieve better vision and reduce pain.

What this could mean

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

Active substance
topical corticosteroid (dexamethasone)
What this could lead to
If successful, adding steroids could reduce inflammation and improve vision outcomes for people with this rare eye infection.
What could go wrong
This is a Phase 3 trial, but it only includes people who still have inflammation after 4 weeks of standard treatment. Steroids may also suppress the immune response, potentially worsening the infection.

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 232 people

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

Started

Jul 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

8 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.

Inclusion Criteria: * AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy * Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation Exclusion Criteria: * Evidence or history of interstitial keratitis * Known herpetic keratitis, as determined from history, exam, or microbiological testing * Known fungal keratitis, as demonstrated from corneal scrapings * Corneal perforation or impending corneal perforation * Prior therapeutic keratoplasty for acanthamoeba keratitis * Unwillingness or inability to follow-up * No light perception in the affected eye * Known hypertensive response to steroids * Corticosteroid allergy * Concurrent treatment with systemic corticosteroids * Concurrent granulomatous amoebic encephalitis

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Conditions

The condition(s) this trial relates to.

Acanthamoeba keratitis corneal ulcer

As listed by the trial registrant

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

Acanthamoeba keratitis

How to take part

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

  1. The places running it

    17 sites in 4 countries. 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

  • Aravind Eye Hospital

    RECRUITING

    Coimbatore, Tamil Nadu, India

  • Aravind Eye Hospital

    RECRUITING

    Madurai, Tamil Nadu, India

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Federal University of São Paulo

    RECRUITING

    São Paulo, Brazil

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Moorfields Eye Hospital

    RECRUITING

    London, United Kingdom

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Colorado Anschutz

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32605, United States

  • University of Illinois, Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.