Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05110001

Acronym

REAGIR

Enrollment

330

Registered

2021-11-05

Start date

2022-08-03

Completion date

2025-06-30

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acanthamoeba Keratitis, Fungal Keratitis

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.

Interventions

DRUGMoxifloxacin Ophthalmic

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

DRUGChlorhexidine Gluconate

Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.

DRUGNatamycin

Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.

DRUGRose 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 5-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.

OTHERPlacebo

Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Best Spectacle-Corrected Visual Acuity	6 Months	Best Spectacle-Corrected Visual Acuity

Secondary

Measure	Time frame	Description
Best Spectacle-Corrected Visual Acuity	3 Weeks, 3 Months, 12 Months	Best Spectacle-Corrected Visual Acuity
Scar Size	3 Weeks, 3 Months, 6 Months 12 Months	Geometric Mean

Countries

Brazil, India

Contacts

PRINCIPAL_INVESTIGATORTom Lietman, MD

University of California, San Frnasco

PRINCIPAL_INVESTIGATORJennifer Rose-Nussbaumer, MD

Stanford University

STUDY_DIRECTORNicole Varnado, MPH