Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

NCT06271772 | Active Not Recruiting Phase 3

• 1 other identifier: 18-26045-RII
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT). Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:

• Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT
• Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT

Conditions

Bacterial Keratitis

Outcome Measures

Primary Outcomes (1)

• Best Spectacle-Corrected Visual Acuity

  Best Spectacle-Corrected Visual Acuity

  6 months

Secondary Outcomes (4)

• Best Spectacle-Corrected Visual Acuity

  3 Weeks, 3 Months, 12 Months

• Scar size

  3 Weeks, 3 Months, 6 Months 12 Months

• Scar depth

  3 Weeks, 3 Months, 6 Months 12 Months

• Adverse Events

  12 Months

Study Arms (2)

RB-PDT Plus Early Steroids

EXPERIMENTAL

Drug: Difluprednate Ophthalmic; Drug: Rose Bengal; Drug: Moxifloxacin Ophthalmic

Sham RB-PDT Plus Early Steroids

EXPERIMENTAL

Drug: Difluprednate Ophthalmic; Drug: Moxifloxacin Ophthalmic

Interventions

Difluprednate Ophthalmic DRUG

Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy.

RB-PDT Plus Early Steroids; Sham RB-PDT Plus Early Steroids

Rose Bengal DRUG

Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 3-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.

Also known as: Corneal Cross Linking with rose Bengal

RB-PDT Plus Early Steroids

Moxifloxacin Ophthalmic DRUG

Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.

RB-PDT Plus Early Steroids; Sham RB-PDT Plus Early Steroids

Eligibility Criteria

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

You may qualify if:

• Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria)
• Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
• Corneal thickness ≥350 µm, as measured on AS-OCT
• Age over 18 years
• Basic understanding of the study as determined by the physician
• Commitment to return for follow up visits

You may not qualify if:

• Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain)
• 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
• History of intraocular surgery within the last three months\*
• Pinhole visual acuity worse than 20/200 in the unaffected eye
• Participants who are decisionally and/or cognitively impaired

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator
• Aravind Eye Care System: collaborator
• Federal University of São Paulo: collaborator

Study Sites (2)

Federal University of São Paulo

São Paulo, Brazil

Location

Aravind Eye Care System

Madurai, Tamil Nadu, India

Location

MeSH Terms

Interventions

Rose Bengal; Corneal Cross-Linking

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Photochemotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Jennifer Rose-Nussbaumer, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Thomas Lietman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nicole Varnado, MPH

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); IN (1)