Parasitic Ulcer Treatment Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, Los Angeles
NOT_YET_RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Florida
University of Florida
RECRUITING
Gainesville
University of Miami
RECRUITING
Miami
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
University of Illinois, Chicago
RECRUITING
Chicago
Maryland
Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
New York
Columbia University
NOT_YET_RECRUITING
New York
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Other Locations
Brazil
Federal University of São Paulo
RECRUITING
São Paulo
India
Aravind Eye Hospital
RECRUITING
Coimbatore
Aravind Eye Hospital
RECRUITING
Madurai
United Kingdom
Moorfields Eye Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Jeremy Keenan, MD, MPH
jeremy.keenan@ucsf.edu
415-476-6323
Backup
Krisi Aromin
krisianne.aromin@ucsf.edu
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2028-07
Participants
Target number of participants: 232
Treatments
Experimental: Topical steroids
Participants in this arm will receive anti-amoebic therapy plus topical steroids.
Placebo_comparator: Topical placebo
Participants in this arm will receive anti-amoebic therapy plus topical placebo.
Related Therapeutic Areas
Sponsors
Collaborators: Federal University of São Paulo, University of Florida, University of Miami, Oregon Health and Science University, University of Pittsburgh, Moorfields Eye Hospital NHS Foundation Trust, University of Pennsylvania, Aravind Eye Care System, Columbia University, University of Iowa, Johns Hopkins University, University of Illinois at Chicago, University of California, Los Angeles, National Eye Institute (NEI)
Leads: Jeremy Keenan, MD, MPH

This content was sourced from clinicaltrials.gov