Status:
RECRUITING
Parasitic Ulcer Treatment Trial
Lead Sponsor:
Jeremy Keenan, MD, MPH
Collaborating Sponsors:
Johns Hopkins University
Oregon Health and Science University
Conditions:
Acanthamoeba Keratitis
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
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 regime...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT06213649
Start Date
July 1 2024
End Date
July 1 2028
Last Update
October 28 2025
Active Locations (16)
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1
University of California, San Francisco
San Francisco, California, United States, 94158
2
University of Florida
Gainesville, Florida, United States, 32605
3
University of Miami
Miami, Florida, United States, 33136
4
University of Illinois, Chicago
Chicago, Illinois, United States, 60612