search
Back to results

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction (REAGIR)

Primary Purpose

Acanthamoeba Keratitis, Fungal Keratitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Moxifloxacin Ophthalmic
Chlorhexidine Gluconate
Natamycin
Rose Bengal
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acanthamoeba Keratitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Federal University of São PauloRecruiting
  • Aravind Eye Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard Therapy

Cross-Linking with rose Bengal (RB-PDT)

Arm Description

Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT

Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT

Outcomes

Primary Outcome Measures

Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity

Secondary Outcome Measures

Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Scar Size
Geometric Mean
Scar Depth
Geometric Mean
Adverse Events
Adverse Events

Full Information

First Posted
October 26, 2021
Last Updated
May 10, 2023
Sponsor
University of California, San Francisco
Collaborators
Aravind Eye Care System, National Eye Institute (NEI), Stanford University, Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT05110001
Brief Title
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Acronym
REAGIR
Official Title
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Aravind Eye Care System, National Eye Institute (NEI), Stanford University, Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acanthamoeba Keratitis, Fungal Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
Placebo Comparator
Arm Description
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Arm Title
Cross-Linking with rose Bengal (RB-PDT)
Arm Type
Experimental
Arm Description
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Ophthalmic
Intervention Description
Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate
Intervention Description
Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Intervention Type
Drug
Intervention Name(s)
Natamycin
Intervention Description
Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Intervention Type
Drug
Intervention Name(s)
Rose Bengal
Other Intervention Name(s)
Corneal Cross Linking with rose Bengal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Spectacle-Corrected Visual Acuity
Description
Best Spectacle-Corrected Visual Acuity
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Best Spectacle-Corrected Visual Acuity
Description
Best Spectacle-Corrected Visual Acuity
Time Frame
3 Weeks, 3 Months, 12 Months
Title
Scar Size
Description
Geometric Mean
Time Frame
3 Weeks, 3 Months, 6 Months 12 Months
Title
Scar Depth
Description
Geometric Mean
Time Frame
3 Weeks, 3 Months, 6 Months 12 Months
Title
Adverse Events
Description
Adverse Events
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Lietman, MD
Phone
415-502-2662
Email
tom.lietman@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Rose-Nussbaumer, MD
Email
rosej@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Lietman, MD
Organizational Affiliation
University of California, San Frnasco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Rose-Nussbaumer, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole Varnado, MPH
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Luisa Hofling Lima, MD, PhD
Email
analhofling@gmail.com
Facility Name
Aravind Eye Care System
City
Madurai
State/Province
Tamil Nadu
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N V Prajna
Email
prajna@aravind.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction

We'll reach out to this number within 24 hrs