RB-PDT for Fusarium Keratitis: The LUMIERE Study
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Stanford University
- Study ID
- NCT07743489
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Fusarium Keratitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rose Bengal Photodynamic Therapy — DRUGRB-PDT/sham RB-PDT will occur within 5 days of initial smear/culture. For Group 1, Rose Bengal (0.1% RB in 0.9% sodium chloride) will be applied in 3-minute intervals to the de-epithelialized cornea for 30 minutes followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). A second RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
- Sham RB-PDT — DRUGParticipants in Group 2 will undergo a sham procedure using topical balanced salt solution and pen light covered with a green filter. Study participants will undergo repeat scraping and culture of the corneal ulcer 30 minutes after the assigned RB-PDT procedure. A second sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
Study Details
This is a multicenter trial with recruitment planned at ophthalmology clinics specializing in corneal diseases in India, Brazil, and at Stanford University and Bascom Palmer Eye Institute in the United States. Fusarium keratitis is common in tropical and subtropical regions like Florida, India and Brazil, which will facilitate access to the required number of participants. The study aims to recruit a total of 434 participants (217 per group).
Key Dates
- First listed
- Aug 4, 2026
- Start date
- Jan 31, 2027
- Status verified
- Jul 2026
- Primary completion
- Apr 30, 2029
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 434 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Group 1: RB-PDTGroup 1 participants will receive natamycin 5%/Amphotericin B 0.15% plus RB-PDT
- Sham Comparator: Group 2: Sham RB-PDTGroup 2 participants will receive natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT
Primary Outcome Measure
BSCVA at 3 months [ Time Frame: 3 months post-op ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94303 | Jennifer Rose-Nussbaumer, MD (PRINCIPAL_INVESTIGATOR) |
| University of Miami - Bascom Palmer Eye Institute | Miami | Florida | 33136 | Guillermo Amescua, MD (PRINCIPAL_INVESTIGATOR) |