Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction

Phase 3

Active, not recruiting

• Conditions: Acanthamoeba Keratitis; Fungal Keratitis
• Interventions: Drug: Moxifloxacin Ophthalmic; Drug: Chlorhexidine Gluconate; Drug: Natamycin; Other: Placebo; Drug: Rose Bengal

• Registration Number: NCT05110001
• Lead Sponsor: University of California, San Francisco

Brief Summary

Rose Bengal Electromagnetic Activation with Green light for Infection Reduction (REAGIR ) is an international, randomized, doubled masked, clinical trial. 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 either smear or culture positive fungal or acanthamoeba keratitis or smear and culture negative corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:

Group 4, Sham RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT

Group 5, RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-05
• Study Start: 2022-08-03
• Primary Completion: 2024-12-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Presence of smear or culture positive fungal or acanthamoeba ulcer; smear or culture negative ulcer; or any atypical bacteria (such as Nocardia)
• 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
• Non-infectious or autoimmune keratitis
• History of corneal transplantation
• History of intraocular surgery within last three months
• Pinhole visual acuity worse than 20/200 in the unaffected eye
• Participants who are decisionally and/or cognitively impaired
• Presence of demestocele at recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Chlorhexidine Gluconate	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Standard Therapy	Natamycin	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Standard Therapy	Placebo	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Cross-Linking with rose Bengal (RB-PDT)	Moxifloxacin Ophthalmic	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Cross-Linking with rose Bengal (RB-PDT)	Chlorhexidine Gluconate	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Cross-Linking with rose Bengal (RB-PDT)	Rose Bengal	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Standard Therapy	Moxifloxacin Ophthalmic	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Cross-Linking with rose Bengal (RB-PDT)	Natamycin	Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Best Spectacle-Corrected Visual Acuity	3 Weeks, 3 Months, 12 Months	Best Spectacle-Corrected Visual Acuity
Scar Depth	3 Weeks, 3 Months, 6 Months 12 Months	Geometric Mean
Scar Size	3 Weeks, 3 Months, 6 Months 12 Months	Geometric Mean
Adverse Events	12 Months	Adverse Events

Trial Locations

Locations (2)

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

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