Rose Bengal Photodynamic Therapy for Fusarium Keratitis

Not yet recruiting at 3 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Rose Bengal Photodynamic Therapy (RB-PDT) for fusarium keratitis, a fungal eye infection that can cause vision loss. Researchers aim to determine if RB-PDT, combined with standard medications, can improve patient outcomes. Participants will be divided into two groups: one will receive RB-PDT, and the other will receive a sham treatment (placebo). The study seeks individuals diagnosed with fusarium keratitis who experience moderate to severe vision loss. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that Rose Bengal Photodynamic Therapy is likely to be safe for humans?

Research has shown that Rose Bengal Photodynamic Therapy (RB-PDT) is generally safe for treating eye infections. Past studies reported no recurrence of infection or serious side effects. The treatment appears to protect crucial parts of the eye, such as the thin layer inside the cornea. Over 130 patients have received RB-PDT without major issues, indicating that it is well-tolerated, though individual experiences may vary. These findings may help prospective trial participants feel more informed about the treatment's safety.12345

Why do researchers think this study treatment might be promising for Fusarium keratitis?

Rose Bengal Photodynamic Therapy (RB-PDT) is unique because it offers a novel approach to treating Fusarium keratitis by utilizing light activation to target fungal infections directly. Unlike traditional antifungal treatments like natamycin and amphotericin B, which rely on chemical mechanisms alone, RB-PDT involves applying a photosensitive dye (Rose Bengal) that, when activated by light, produces reactive oxygen species to destroy the fungi. Researchers are excited about this therapy because it has the potential to enhance the effectiveness of existing antifungal treatments, possibly leading to quicker recovery times and improved outcomes for patients with this challenging eye condition.

What evidence suggests that Rose Bengal Photodynamic Therapy might be an effective treatment for Fusarium keratitis?

Research has shown mixed results for Rose Bengal Photodynamic Therapy (RB-PDT) in treating fungal eye infections like Fusarium keratitis. One study successfully treated about 72% of patients with fungal keratitis using RB-PDT. This therapy creates special molecules that help kill the fungus causing the infection. Another study found that patients with Fusarium keratitis improved in about 39 days on average. Although some reports mention that RB-PDT doesn't penetrate the eye deeply, it still shows promise for infections resistant to many drugs. In this trial, participants in Group 1 will receive RB-PDT, while those in Group 2 will receive a sham RB-PDT for comparison.12678

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Fusarium keratitis, a fungal infection of the eye. Participants must be able to visit one of the study clinics in India, Brazil, or the US. Other specific inclusion and exclusion criteria apply as determined by the study doctors.

Inclusion Criteria

I have a confirmed fusarium fungal eye infection.
Corneal thickness ≥350 µm, as measured on AS-OCT
Commitment to return for follow up visits
See 3 more

Exclusion Criteria

I have trouble making decisions or understanding information due to cognitive issues.
My good eye cannot see better than 20/200 with a pinhole test.
History of hypersensitivity to Rose Bengal
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive topical antimicrobial treatment every hour while awake for the first week

1 week
Initial visit for diagnosis and treatment initiation

RB-PDT/Sham Procedure

Participants undergo RB-PDT or sham procedure within 5 days of initial smear/culture

5 days
1 visit for procedure

Follow-up Treatment

Topical antimicrobial treatment every 2 hours while awake for 3 weeks, then tapered based on response

3 weeks

Second RB-PDT/Sham Procedure

A second RB-PDT or sham procedure and repeat smear/culture one week after the first procedure

1 week
1 visit for second procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Follow-up visits including 3-month post-op BSCVA measurement

What Are the Treatments Tested in This Trial?

Interventions

  • Rose Bengal Photodynamic Therapy

Trial Overview

The study compares Rose Bengal Photodynamic Therapy (RB-PDT), a light-based treatment using a special dye, against a sham (inactive) version to see if RB-PDT helps treat Fusarium keratitis. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Group 1: RB-PDTActive Control1 Intervention
Group II: Group 2: Sham RB-PDTPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

University of Miami

Collaborator

Trials
976
Recruited
423,000+

Aravind Eye Care System

Collaborator

Trials
13
Recruited
102,000+

Federal University of São Paulo

Collaborator

Trials
477
Recruited
109,000+

Citations

Rose Bengal Photodynamic Antimicrobial Therapy - PMC - NIH

The purpose of this report is to present both in-vitro and in-vivo efficacy of rose bengal PDAT in multidrug-resistant Fusarium keratitis. MATERIALS AND ...

Clinical Outcomes of Rose Bengal Mediated Photodynamic ...

The clinical resolution was achieved in the cases with Fusarium keratitis with an average time of 39 days. Three cases of A. flavus and a single patient with ...

Rose Bengal PDT Has Mixed Results for Fungal Keratitis

The primary outcome was best spectacle-corrected VA at six months. Secondary outcomes included VA at three weeks and three months; therapy ...

Photodynamic antimicrobial therapy with Erythrosin B ...

One promising treatment modality is Rose Bengal (RB) photodynamic antimicrobial therapy (PDAT) that has shown mixed success against fungal keratitis.

Katherine Krishna and Brandon Chou discuss their study ...

We know Rose Bengal was more contisol works better when applied together but Rose Bengal with the it did have some degradation of the antifungal ...

Rose Bengal Electromagnetic Activation with Green Light ...

Rose bengal PDT improved BSCVA among eyes with Fusarium infections (difference, –0.17 logarithm of the minimum angle of resolution [logMAR]; 95% CI, –0.37 to ...

Rose Bengal Photodynamic Antimicrobial Therapy for ...

RB PDAT is safe for the eye, showing the preservation of the corneal endothelium, iris, and keratocytes, BPEI has treated over 130 patients and ...

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Library of Articles

Rose Bengal photodynamic antimicrobial therapy (RB-PDAT) has poor corneal penetration, limiting its efficacy against acanthamoeba keratitis(AK).