Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Tom Lietman, MD
Photo of Tom Lietman
Tom Lietman

Description

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 (RGX). Patients presenting to one of the Aravind Eye Hospitals in India or to the University of California San Francisco (UCSF) 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 RGX: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RGX Group 5, RGX: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RGX.

Keywords

Acanthamoeba Keratitis Fungal Keratitis Keratitis Chlorhexidine Chlorhexidine gluconate Natamycin Moxifloxacin Moxifloxacin Ophthalmic Rose Bengal

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Francis I. Proctor Foundaiton
    San Francisco California 94143 United States
  • Stanford University
    Palo Alto California 94305 United States

Lead Scientist at UCSF

  • Tom Lietman, MD
    Professor, Proctor Foundation. Authored (or co-authored) 395 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas M. Lietman
ID
NCT05110001
Phase
Phase 3
Study Type
Interventional
Last Updated