Clinical trial NCT05110001: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Official title: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acanthamoeba Keratitis
Fungal Keratitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Aravind Eye Care System
name: National Eye Institute (NEI)
name: Stanford University
name: Federal University of São Paulo
First posted: 2021-11-05
Enrollment: 330
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 (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.


Eligibility criteria: 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

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: University of California, San Frnasco
name: Tom Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jennifer Rose-Nussbaumer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nicole Varnado, MPH
role: STUDY_DIRECTOR
References: