Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

Bacterial Keratitis Clinical Trial

— REAGIR II  

Official title:

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271772
• Other study ID #: 18-26045-RII
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 30, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Jennifer Rose-Nussbaumer, MD
• Phone: 650-402-8820
• Email: rosej[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bacterial Keratitis
• Keratitis

Intervention

Drug:
• Difluprednate Ophthalmic
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.
• Rose Bengal
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.
• Moxifloxacin Ophthalmic
Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo
India	Aravind Eye Care System	Madurai	Tamil Nadu

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Aravind Eye Care System, Federal University of São Paulo, Stanford University

Countries where clinical trial is conducted

Brazil,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Spectacle-Corrected Visual Acuity	Best Spectacle-Corrected Visual Acuity	6 months
Secondary	Best Spectacle-Corrected Visual Acuity	Best Spectacle-Corrected Visual Acuity	3 Weeks, 3 Months, 12 Months
Secondary	Scar size	Geometric mean	3 Weeks, 3 Months, 6 Months 12 Months
Secondary	Scar depth	Geometric mean	3 Weeks, 3 Months, 6 Months 12 Months
Secondary	Adverse Events	Adverse Events	12 Months