RB-PDT for Fusarium Keratitis: The LUMIERE Study
ConditionFusarium Keratitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rose Bengal Photodynamic Therapy
- Sham RB-PDT
Treatment groups
434 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
University of Miami
Collaborator
Aravind Eye Care System
Collaborator
Federal University of São Paulo
Collaborator
Source ClinicalTrials.gov