Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
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.
Timeline
- Start
- 2022-08-03
- Primary completion
- 2024-12-14
- Completion
- 2025-06-30
Outcome
Missed primary endpoint
paper RB-PDT has not been shown to be beneficial at improving best spectacle-corrected visual acuity (BSCVA) PMID 42348235 ↗
paper These findings support 6-month REAGIR results, supporting the likelihood that there is no benefit to adjunctive RB-PDT PMID 42348235 ↗
Publications
- Prajna NV, Bernard A, Prajna L, Rajaraman R, Sharma SS, Christy J, Radhakrishnan N, Mandlik K, De Freitas D, Hofling-Lima AL, Varnado NE, Abdelrahman S, Arnold BF, Lietman TM, Rose-Nussbaumer J; REAGIR Research Group. Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction: Follow-Up of a Randomized Clinical Trial. JAMA Ophthalmol. 2026 Aug 1;144(8):775-779. doi: 10.1001/jamaophthalmol.2026.2257.
- Christy SJ, Mandlik K, Kumar V, Kanchugantla SSSM, Abdelrahman S, Rose-Nussbaumer J. Adjunctive tacrolimus in the treatment of fungal keratitis requiring therapeutic penetrating keratoplasty. Am J Ophthalmol Case Rep. 2025 Dec 29;41:102506. doi: 10.1016/j.ajoc.2025.102506. eCollection 2026 Mar.
- Prajna NV, Lalitha P, Sharma S, de Freitas D, Hofling-Lima A, Varnado N, Abdelrahman S, Cavallino V, Arnold BF, Lietman TM, Rose-Nussbaumer J. A double-masked, sham-controlled trial of rose bengal photodynamic therapy for the treatment of fungal and acanthamoeba keratitis: Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction (REAGIR) study. Trials. 2024 Aug 28;25(1):566. doi: 10.1186/s13063-024-08376-3.
- Prajna V, Prajna L, Sharma S, de Freitas D, Hofling-Lima AL, Varnado N, Abdelrahman S, Cavallino V, Arnold B, Lietman T, Rose-Nussbaumer J. A double-masked, sham-controlled trial of rose bengal photodynamic therapy for the treatment of fungal and acanthameoba keratitis: Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction (REAGIR) Study. Res Sq [Preprint]. 2024 Jul 2:rs.3.rs-4165312. doi: 10.21203/rs.3.rs-4165312/v1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rose bengal disodium | Unknown | 0.1 % | Topical |
| Background | Chlorhexidine gluconate | Other / unclassified | 0.02 % | Topical |
| Background | Moxifloxacin Ophthalmic | Unknown | 0.5 % | Topical |
| Background | Natamycin | Small molecule | 5 % | Topical |