What side effects are associated with this type of intervention?

Common treatments for Acanthamoeba Keratitis include topical chlorhexidine gluconate 0.02% and Rose Bengal Photodynamic Therapy (RB-PDT). Topical chlorhexidine gluconate can cause side effects such as eye irritation, redness, and discomfort. Rose Bengal Photodynamic Therapy, which involves cross-linking with rose Bengal activated by green light, may lead to side effects like temporary eye pain, redness, and photophobia (sensitivity to light). Both treatments aim to reduce infection but can cause some degree of ocular discomfort.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Acanthamoeba Keratitis that are directly comparable to Rose Bengal Photodynamic Therapy (RB-PDT). Traditional treatments for Acanthamoeba Keratitis typically involve antimicrobial agents such as chlorhexidine gluconate and polyhexamethylene biguanide. The RB-PDT method, which involves cross-linking with rose Bengal activated by green light, is currently being studied and represents a novel approach to reducing infection in this condition.

What other types of research exist?

Promising alternatives to RB-PDT for Acanthamoeba Keratitis include the use of topical chlorhexidine gluconate 0.02%, which has been shown to be effective in treating Acanthamoeba infections. Additionally, other antimicrobial treatments such as moxifloxacin 0.5% for smear/culture negative cases and natamycin 5% for fungal keratitis are also viable options. These treatments can be considered based on the specific type of keratitis and the patient's condition.

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Antiseptic

Rose Bengal + Light Therapy for Corneal Inflammation (REAGIR Trial)

Phase 3

Waitlist Available

Led By Jennifer Rose-Nussbaumer, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age over 18 years

Be older than 18 years old

Must not have

Impending or frank perforation at recruitment

History of corneal transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks, 3 months, 6 months 12 months

Awards & highlights

Pivotal Trial

Summary

This trial tests a new treatment using a special dye and green light to help patients with severe eye infections and vision loss. The dye and light work together to kill infections and improve vision.

Who is the study for?

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.

What is being tested?

The REAGIR trial tests if adding Rose Bengal Photodynamic Therapy (RB-PDT) to standard antimicrobial treatments improves visual acuity in patients with certain corneal infections. It's a randomized study where participants either receive RB-PDT or a sham treatment alongside their regular medication.

What are the potential side effects?

Potential side effects may include discomfort at the site of application, light sensitivity due to rose Bengal activation, and typical reactions associated with ophthalmic medications such as redness, irritation, tearing or dry eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at risk of or currently have a ruptured organ.

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I have had a corneal transplant.

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My eye condition involves the sclera.

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I am not able to make decisions or think clearly due to my condition.

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I have keratitis not caused by an infection or autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks, 3 months, 6 months 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks, 3 months, 6 months 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks, 3 months, 6 months 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Spectacle-Corrected Visual Acuity

Secondary study objectives

Adverse Events

Scar Depth

Scar Size

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cross-Linking with rose Bengal (RB-PDT)Experimental Treatment4 Interventions

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

Group II: Standard TherapyPlacebo Group4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moxifloxacin Ophthalmic

2011

Completed Phase 4

~180

Chlorhexidine Gluconate

2014

Completed Phase 4

~2370

Natamycin

2010

Completed Phase 3

~400

Rose Bengal

2015

N/A

~30

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acanthamoeba Keratitis, such as Riboflavin/UVA and Rose Bengal/green light photodynamic therapies (PDT), work by using photosensitizers that are activated by specific wavelengths of light to generate reactive oxygen species (ROS). These ROS cause damage to the cellular components of the Acanthamoeba, leading to cell death. This is particularly important for Acanthamoeba Keratitis patients because the infection is difficult to treat due to the amoeba's resilient cyst form. Effective treatments like RB-PDT can potentially improve patient outcomes by more efficiently eradicating the infection.

Effect of Riboflavin/Rose Bengal-Mediated PACK-CXL on Acanthamoeba Trophozoites and Cysts in Vitro.Effect of photodynamic therapy with methylene blue on Acanthamoeba in vitro.Spatial distribution of protein damage by singlet oxygen in keratinocytes.