Rose Bengal + Light Therapy for Corneal Inflammation
(REAGIR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining rose Bengal with light therapy can improve vision in individuals with specific eye infections. It compares standard antimicrobial treatments to those treatments plus the new therapy. Individuals with fungal or acanthamoeba keratitis (a type of corneal infection) or corneal ulcers of unclear cause, who have noticeable vision loss, might be suitable candidates. The research aims to determine if the new treatment enhances vision recovery more effectively than current methods. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions specific treatments for the trial, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Rose Bengal Photodynamic Therapy (RB-PDT), when combined with green light, holds promise for treating eye infections such as fungal keratitis. Studies have found RB-PDT to be generally safe, with most participants experiencing no serious side effects. Some mild side effects, like temporary eye irritation or redness, were noted but were uncommon.
The study is in an advanced phase, indicating that RB-PDT has already undergone safety testing in earlier stages. This suggests sufficient data exists to show that serious side effects are unlikely.
For those considering joining a trial with RB-PDT, current research supports its safety for human use.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for corneal inflammation, which typically involve antibiotics or antifungals like moxifloxacin or natamycin, the new approach using Rose Bengal with light therapy, or RB-PDT, offers a unique mechanism. Rose Bengal is activated by light to create a cross-linking effect, which can strengthen the corneal tissue and help reduce inflammation more effectively. This method has the potential to provide faster and more targeted relief, making it an exciting development for researchers looking to improve outcomes for patients with corneal issues.
What evidence suggests that Rose Bengal Electromagnetic Activation with Green light might be an effective treatment for corneal inflammation?
Research has shown that rose Bengal photodynamic therapy (RB-PDT) can help treat severe eye infections. In this trial, one group of participants will receive RB-PDT alongside standard treatments, which include topical chlorhexidine gluconate, moxifloxacin, or natamycin, depending on the type of keratitis. One study found that RB-PDT reduced the need for more invasive surgeries in patients with bacterial, fungal, and acanthamoeba keratitis, which are different types of eye infections. It also improved vision over six months when combined with standard treatments for infections. The treatment uses a special dye and light to kill harmful germs in the eye. Early findings suggest it may also help prevent complications like corneal perforation, where the outer layer of the eye gets damaged.12678
Who Is on the Research Team?
Tom Lietman, MD
Principal Investigator
University of California, San Frnasco
Jennifer Rose-Nussbaumer, MD
Principal Investigator
Stanford University
Nicole Varnado, MPH
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with corneal infections like fungal or acanthamoeba keratitis, or negative smear/culture ulcers causing moderate to severe vision loss. Participants must understand the study and commit to follow-up visits. Those with other eye infections, recent eye surgery, very poor vision in the unaffected eye, or cognitive impairments cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard antimicrobial treatment plus sham RB-PDT or antimicrobial treatment plus RB-PDT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chlorhexidine Gluconate
- Moxifloxacin Ophthalmic
- Natamycin
- Rose Bengal Electromagnetic Activation
Chlorhexidine Gluconate is already approved in United States, Canada, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Thomas M. Lietman
Lead Sponsor
Federal University of São Paulo
Collaborator
Aravind Eye Care System
Collaborator
National Eye Institute (NEI)
Collaborator
Stanford University
Collaborator