RB-PDT for Fusarium Keratitis: The LUMIERE Study

NCT07743489 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 86425
• Study Type: interventional
• Target: 434
• Locations: 3 countries
• Sites: 4

Brief Summary

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).

Conditions

Fusarium Keratitis

Keywords

fusarium keratitis; rose bengal; RB-PDT

Outcome Measures

Primary Outcomes (1)

• BSCVA at 3 months

  Best spectacle-corrected visual acuity measured in logMAR at 3 month follow-up visit

  3 months post-op

Study Arms (2)

Group 1: RB-PDT

ACTIVE COMPARATOR

Group 1 participants will receive natamycin 5%/Amphotericin B 0.15% plus RB-PDT

Drug: Rose Bengal Photodynamic Therapy

Group 2: Sham RB-PDT

SHAM COMPARATOR

Group 2 participants will receive natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT

Drug: Sham RB-PDT

Interventions

Rose Bengal Photodynamic Therapy DRUG

RB-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.

Group 1: RB-PDT

Sham RB-PDT DRUG

Participants 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.

Group 2: Sham RB-PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of culture positive fusarium fungal keratitis
• Age over 18 years
• Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) to 20/400 (6/120)
• Corneal thickness ≥350 µm, as measured on AS-OCT
• Basic understanding of the study as determined by the physician
• Commitment to return for follow up visits

You may not qualify if:

• History of hypersensitivity to Rose Bengal
• Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain)
• History of intraocular surgery within the last three months\*
• Impending or frank perforation at recruitment
• Involvement of sclera at presentation
• Presence of desmetocele at recruitment
• Non-infectious or autoimmune keratitis
• History of corneal transplantation
• Pinhole visual acuity worse than 20/200 in the unaffected eye
• Participants who are decisionally and/or cognitively impaired

Sponsors & Collaborators

• Stanford University: lead
• University of Miami: collaborator
• Aravind Eye Care System: collaborator
• Federal University of São Paulo: collaborator

Study Sites (4)

Stanford University

Palo Alto, California, 94303, United States

Location

University of Miami - Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Federal University of São Paulo

São Paulo, 04023-062, Brazil

Location

Aravind Eye Care System

Madurai, Tamil Nadu, 625 020, India

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patient, physicians, microbiologist, and refractionist performing the best spectacle-corrected visual acuity (BSCVA) assessment will be masked to the treatment group. Due to the nature of the intervention, the surgeon and technician performing cross-linking will not be masked. All study medications and placebo will be labelled identically to ensure adequate masking of study physicians and patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IN (1); BR (1)