Parasitic Ulcer Treatment Trial

a study on Acanthamoeba Keratitis

Summary

Eligibility
for people ages 8 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Jeremy Keenan, MD, MPHGerami Seitzman, MD

Description

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 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

Keywords

Acanthamoeba Keratitis, corneal ulcer, steroids, Keratitis, Biguanides, Polihexanide, Polyhexamethylene biguanide (PHMB), Topical corticosteroid, Topical steroids

Eligibility

You can join if…

Open to people ages 8 years and up

  • 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 CAN'T join 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

Locations

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • University of California, Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Oregon Health and Science University accepting new patients
    Portland Oregon 97239 United States

Lead Scientists at UCSF

  • Jeremy Keenan, MD, MPH
  • Gerami Seitzman, MD
    Gerami Seitzman, MD is an Associate Professor of Ophthalmology at the University of California, San Francisco. She is a cornea and external disease specialist at the F.I. Proctor Foundation. She also sees patients with cornea and external disease diagoses at the UCSF Department of Ophthalmology. A native of Michigan, she obtained her undergraduate and medical degrees at the University of Michigan.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jeremy Keenan, MD, MPH
ID
NCT06213649
Phase
Phase 3 Acanthamoeba Keratitis Research Study
Study Type
Interventional
Participants
Expecting 232 study participants
Last Updated
Contact us about this trial