Fusarium KeratitisPhase 3NCT07743489
RB-PDT for Fusarium Keratitis: The LUMIERE Study
A Phase 3 study testing Rose Bengal Photodynamic Therapy in people with Fusarium Keratitis, run by Stanford University at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fusarium Keratitis
- What is being tested?
- Rose Bengal Photodynamic Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 434 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2027to Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 desmestocele at recruitment
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites
University of Miami - Bascom Palmer Eye Institute
Miami, Florida, 33136
Guillermo Amescua, MD, 412-592-5665, GAmescua@med.miami.edu
Guillermo Amescua, MD
Stanford University
Palo Alto, California, 94303
Jennifer Rose-Nussbaumer, MD, 650-498-8790, rosej@stanford.edu
Nicole Varnado, MPH, 650-725-1688, nvarnado@stanford.edu
Brazil1 site
Federal University of São Paulo
São Paulo, 04023-062
Ana Luisa Höfling-Lima, MD PhD, +55 11 99982-1276, analhofling@gmail.com
Ana Luisa Höfling-Lima, MD PhD
India1 site
Aravind Eye Care System
Madurai, Tamil Nadu, 625 020
NV Prajna, MD DNB FICO, +91 98946 53561, prajna@aravind.org
NV Prajna, MD DNB FICO
About this study
Official title: Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
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).
Read the detailed description
Participants with fusarium corneal ulcers will be randomized in a 1:1 fashion to one of two arms:
- Group 1, RB-PDT: natamycin 5%/Amphotericin B 0.15% plus RB-PDT
- Group 2, Sham RB-PDT: natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT
Participants will begin topical antimicrobial upon initial diagnosis: applied to the affected eye every hour while awake for the first week, then every 2 hours while awake for 3 weeks. Thereafter, application will be tapered at the discretion of the treating physician based on response to therapy.
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). 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 RB-PDT/sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
- Conditions
- Fusarium Keratitis
- Being tested
- Rose Bengal Photodynamic Therapy, Sham RB-PDT
- Keywords
- fusarium keratitis, rose bengal, RB-PDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rose Bengal Photodynamic TherapyDrug
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.
Sham RB-PDTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: RB-PDT | Active comparator | Group 1 participants will receive natamycin 5%/Amphotericin B 0.15% plus RB-PDT Receives: 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 Receives: Drug: Sham RB-PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSCVA at 3 months
Best spectacle-corrected visual acuity measured in logMAR at 3 month follow-up visit
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusarium KeratitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Aravind Eye Care System, Federal University of São Paulo
- Responsible party
- Principal investigator, Jennifer Rose-Nussbaumer, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743489
- Sponsor's protocol ID
- 86425
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
- ClinicalTrials.gov ID
- NCT07743489
- Acronym / sponsor ID
- 86425
- Conditions
- Fusarium Keratitis
- Keywords
- fusarium keratitis, rose bengal, RB-PDT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Miami, Aravind Eye Care System, Federal University of São Paulo
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Participants with fusarium corneal ulcers will be randomized in a 1:1 fashion to one of two arms:
- Group 1, RB-PDT: natamycin 5%/Amphotericin B 0.15% plus RB-PDT
- Group 2, Sham RB-PDT: natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT
Participants will begin topical antimicrobial upon initial diagnosis: applied to the affected eye every hour while awake for the first week, then every 2 hours while awake for 3 weeks. Thereafter, application will be tapered at the discretion of the treating physician based on response to therapy.
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). 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 RB-PDT/sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: RB-PDT | Active comparator | Drug: Rose Bengal Photodynamic TherapyGroup 1 participants will receive natamycin 5%/Amphotericin B 0.15% plus RB-PDT |
| Group 2: Sham RB-PDT | Sham comparator | Drug: Sham RB-PDTGroup 2 participants will receive natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rose Bengal Photodynamic TherapyRB-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. | Drug | Group 1: RB-PDT |
| Sham RB-PDTParticipants 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. | Drug | Group 2: Sham RB-PDT |
Primary outcome
BSCVA at 3 months
Time frame: 3 months post-op
Best spectacle-corrected visual acuity measured in logMAR at 3 month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Miami - Bascom Palmer Eye Institute
Miami, United States
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rose Bengal Photodynamic Therapy in people with Fusarium Keratitis, run by Stanford University at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Brazil, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSCVA at 3 months (time frame: 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.