Treatment for Acanthamoeba Keratitis with Corticosteroids
Parasitic Ulcer Treatment Trial
This study is testing if adding corticosteroids to the treatment for acanthamoeba keratitis can help improve vision and reduce inflammation in patients who haven't seen improvement after four weeks of standard therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 17 sites (San Francisco, California and 16 other locations) |
| Trial ID | NCT06213649 on ClinicalTrials.gov |
What this trial studies
The Parasitic Ulcer Treatment Trial evaluates the effectiveness of adding topical corticosteroids to the treatment regimen for patients with acanthamoeba keratitis who show ocular inflammation after four weeks of anti-amoebic therapy. This multi-center, randomized clinical trial will compare the outcomes of patients receiving corticosteroids against those receiving a placebo. Participants will be monitored for improvements in vision and inflammation levels. The trial aims to provide insights into whether corticosteroids can enhance recovery in this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with acanthamoeba keratitis who exhibit ocular inflammation after one month of anti-amoebic treatment.
Not a fit: Patients with a history of interstitial keratitis, herpetic keratitis, or those who are allergic to corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision outcomes for patients suffering from acanthamoeba keratitis.
How similar studies have performed: Previous studies have shown promise in using corticosteroids for inflammatory conditions, but this specific approach for acanthamoeba keratitis is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 16 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- University of Colorado Anschutz — Aurora, Colorado, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- University of Illinois, Chicago — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Federal University of São Paulo — São Paulo, Brazil (Recruiting)
- Aravind Eye Hospital — Coimbatore, Tamil Nadu, India (Recruiting)
- Aravind Eye Hospital — Madurai, Tamil Nadu, India (Recruiting)
- Moorfields Eye Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jeremy Keenan, MD, MPH — Proctor Foundation, UCSF
- Study coordinator: Jeremy Keenan, MD, MPH
- Email: jeremy.keenan@ucsf.edu
- Phone: 415-476-6323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.