Clinical trial NCT06213649: Parasitic Ulcer Treatment Trial
Official title: Parasitic Ulcer Treatment Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acanthamoeba Keratitis
Keywords: corneal ulcer
steroids
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Oregon Health and Science University
name: University of Illinois at Chicago
name: University of Michigan
name: University of California, Los Angeles
name: University of Pittsburgh
name: University of Pennsylvania
name: Columbia University
name: University of Iowa
name: University of Florida
name: Aravind Eye Care System
name: Moorfields Eye Hospital NHS Foundation Trust
name: Federal University of São Paulo
name: National Eye Institute (NEI)
First posted: 2024-01-19
Enrollment: 232
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: 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

Primary outcomes:
measure: Vision
timeFrame: 6 Months
Secondary outcomes:
measure: Self-reported eye pain
timeFrame: 2 months
measure: Clinical Resolution
timeFrame: 12 months
measure: Multivariate Analysis
timeFrame: 6 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Columbia University
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
city: Coimbatore
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Proctor Foundation, UCSF
name: Jeremy Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: