RB-PDT for Fusarium Keratitis: The LUMIERE Study

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Fusarium Keratitis

In brief

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 facts

Study ID

NCT07743489

Run by

Stanford University

People needed

434

Starts

2027-01-01

Expected to finish

2030-01-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Stanford University — Palo Alto, California, United States
• University of Miami - Bascom Palmer Eye Institute — Miami, Florida, United States
• Federal University of São Paulo — São Paulo, Brazil
• Aravind Eye Care System — Madurai, Tamil Nadu, India

Full record on ClinicalTrials.gov

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