Parasitic Ulcer Treatment Trial

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acanthamoeba Keratitis

In brief

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: * Group 1: Topical corticosteroid * Group 2: Topical placebo

Key facts

Study ID

NCT06213649

Run by

Jeremy Keenan, MD, MPH

People needed

232

Starts

2024-07-01

Expected to finish

2029-07-01

Last updated by the study team

2026-05-01

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• University of Colorado Anschutz — Aurora, Colorado, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• University of Illinois, Chicago — Chicago, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Federal University of São Paulo — São Paulo, Brazil (enrolling)
• Aravind Eye Hospital — Coimbatore, Tamil Nadu, India (enrolling)
• Aravind Eye Hospital — Madurai, Tamil Nadu, India (enrolling)
• Moorfields Eye Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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