RB-PDT for Fusarium Keratitis: The LUMIERE Study | NCT07743489

NCT07743489

Overview

NCT ID: NCT07743489
Lead Sponsor: Stanford UniversityOTHER
Official Title: Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
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
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Jan 2027Estimated
Primary Completion Date: Apr 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 434Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Stanford University

Similar Studies

Rose Bengal Photodynamic Therapy

Masking Description

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.

Observational Model

No data available

Time Perspective

No data available

Participant Group/Arms

Group 1: RB-PDTActive Comparator

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

Drug: Rose Bengal Photodynamic Therapy

Group 2: Sham RB-PDTSham Comparator

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

Drug: Sham RB-PDT

Palo Alto, California 94303, United States

Jennifer Rose-Nussbaumer, MDContact

rosej@stanford.edu650-498-8790

Nicole Varnado, MPHContact

nvarnado@stanford.edu650-725-1688

Jennifer Rose-Nussbaumer, MDPrincipal Investigator

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