Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

Phase 3

Recruiting

• Conditions: Bacterial Keratitis
• Interventions: Drug: Difluprednate Ophthalmic; Drug: Rose Bengal; Drug: Moxifloxacin Ophthalmic

• Registration Number: NCT06271772
• Lead Sponsor: University of California, San Francisco

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-22
• Study Start: 2024-07-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RB-PDT Plus Early Steroids	Difluprednate Ophthalmic	-
RB-PDT Plus Early Steroids	Moxifloxacin Ophthalmic	-
RB-PDT Plus Early Steroids	Rose Bengal	-
Sham RB-PDT Plus Early Steroids	Difluprednate Ophthalmic	-
Sham RB-PDT Plus Early Steroids	Moxifloxacin Ophthalmic	-

Primary Outcome Measures

Name	Time	Method
Best Spectacle-Corrected Visual Acuity	6 months	Best Spectacle-Corrected Visual Acuity

Secondary Outcome Measures

Name	Time	Method
Scar size	3 Weeks, 3 Months, 6 Months 12 Months	Geometric mean
Scar depth	3 Weeks, 3 Months, 6 Months 12 Months	Geometric mean
Best Spectacle-Corrected Visual Acuity	3 Weeks, 3 Months, 12 Months	Best Spectacle-Corrected Visual Acuity
Adverse Events	12 Months	Adverse Events

Trial Locations

Locations (2)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil

Aravind Eye Care System; 🇮🇳 Madurai, Tamil Nadu, India