Clinical trial NCT06271772: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Official title: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bacterial Keratitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Aravind Eye Care System
name: Federal University of São Paulo
First posted: 2024-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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

Primary outcomes:
measure: Best Spectacle-Corrected Visual Acuity
timeFrame: 6 months
Secondary outcomes:
measure: Best Spectacle-Corrected Visual Acuity
timeFrame: 3 Weeks, 3 Months, 12 Months
measure: Scar size
timeFrame: 3 Weeks, 3 Months, 6 Months 12 Months
measure: Scar depth
timeFrame: 3 Weeks, 3 Months, 6 Months 12 Months
measure: Adverse Events
timeFrame: 12 Months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
city: Madurai
country: India
facility: Aravind Eye Care System
state: Tamil Nadu
Study officials:
affiliation: Stanford University
name: Jennifer Rose-Nussbaumer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Thomas Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nicole Varnado, MPH
role: STUDY_DIRECTOR
References: