NCT06213649 Parasitic Ulcer Treatment Trial
| NCT ID | NCT06213649 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jeremy Keenan, MD, MPH |
| Condition | Acanthamoeba Keratitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 232 participants in total. It began in 2024-07-01 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Jeremy Keenan, MD, MPH
PRINCIPAL INVESTIGATOR
Proctor Foundation, UCSF
Frequently Asked Questions
Who can join the NCT06213649 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Acanthamoeba Keratitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06213649 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 232 participants.
Is NCT06213649 currently recruiting?
Yes, NCT06213649 is actively recruiting participants. Contact the research team at jeremy.keenan@ucsf.edu for enrollment information.
Where is the NCT06213649 trial being conducted?
This trial is being conducted at San Francisco, United States, Aurora, United States, Gainesville, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT06213649 clinical trial?
NCT06213649 is sponsored by Jeremy Keenan, MD, MPH. The principal investigator is Jeremy Keenan, MD, MPH at Proctor Foundation, UCSF. The trial plans to enroll 232 participants.