What is the mechanism of action of this treatment?

Corneal melt is a severe condition characterized by the thinning of the cornea, which can lead to ocular perforation and blindness. Treatments like infliximab, a TNF-alpha inhibitor, work by reducing inflammation and preventing further corneal degradation. TNF-alpha inhibitors block the activity of tumor necrosis factor-alpha, a cytokine involved in systemic inflammation, thereby reducing the inflammatory response that contributes to corneal melt. This is crucial for patients as it helps to stabilize the cornea, prevent further damage, and preserve vision.

What side effects are associated with this type of intervention?

Treatments for corneal melt, particularly TNF-alpha inhibitors like infliximab, can cause infusion reactions, increased risk of infections, and antibody development against the drug. Other treatments, such as corticosteroids and calcineurin inhibitors, may lead to side effects like stinging, eyelid maceration, and increased intraocular pressure.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for corneal melt involving TNF-alpha inhibitors like infliximab in the provided context. However, infliximab has been used intravenously to treat corneal melt in patients with inflammatory or autoimmune diseases. Other treatments for corneal melt are not detailed in the context, so a broader search would be necessary to identify additional FDA-approved therapies.

What other types of research exist?

Promising novel alternatives to Infliximab for corneal melt patients in 2024 include topical cyclosporine, lifitegrast, and integrin antagonists. These treatments target different inflammatory pathways and have shown efficacy in managing ocular surface inflammation.

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Monoclonal Antibodies

Topical Infliximab for Corneal Melt

Phase 1

Recruiting

Led By Marie-Claude Robert, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Age 18 to 80 years

Capable of administering eye drops either themselves or through a caregiver

Must not have

History of neoplasia diagnosed within the last 5 years

Past or present use of anti-TNF-α medications or human interleukin-1 receptor antagonist (anakinra, IL-1Ra)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests infliximab eye drops on patients with severe eye thinning due to autoimmune diseases. The drops aim to reduce inflammation by blocking a harmful protein. The study will check if these drops are safe and effective. Infliximab has been used effectively in various forms of eye inflammation, including uveitis and scleritis, often when other treatments have failed.

Who is the study for?

This trial is for adults aged 18-80 with active sterile corneal melting, which isn't caused by an infection. Participants must be able to give consent and use eye drops themselves or with help. They can't have used certain immune system drugs, have a recent cancer history, heart failure, demyelinating disease, diabetes, be pregnant/breastfeeding or allergic to the study drug.

What is being tested?

The trial tests if Infliximab eye drops are safe for treating sterile corneal melt—a serious condition where the clear front part of the eye thins without infection. The hypothesis is that applying Infliximab directly to the eyes might prevent damage and preserve vision.

What are the potential side effects?

While not specified here, typical side effects of topical Infliximab may include irritation at application site, increased risk of local infections in the eye area due to immune suppression and potential systemic absorption leading to broader immunosuppressive effects.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 80 years old.

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I can put in my eye drops or have someone who can do it for me.

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I have a condition where my cornea is thinning and has an open sore, confirmed by an eye exam.

Exclusion Criteria

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

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I was diagnosed with cancer within the last 5 years.

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I have used medications like anti-TNF or anakinra in the past or currently.

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I have diabetes.

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I am allergic to infliximab or its components.

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I have a condition that damages the protective covering of my nerves.

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I have been diagnosed with congestive heart failure.

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I do not have any active infections, including TB or hepatitis B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Percentage of patients finishing 4 weeks of infliximab use

Secondary study objectives

Conjunctival hyperemia using a slit-lamp photographs

Corneal thickness as measured by anterior segment optical coherence tomography

Eyes requiring tectonic surgery

+4 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393

52%

Laceration

38%

Headache

24%

Bruises

19%

Sore throat

14%

Muscle tension

10%

Nausea

10%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Dizziness

10%

Itchiness

Pain in joints

Chest pain

Stomach ache

Syncope

Menstruation

Migraine

Swelling

Bloody stool

Pain in leg

Allergies

Change in blood pressure

Vertigo

Change in appetite

Numbness

Motor vehicle accident

100%

80%

60%

40%

20%

Study treatment Arm

Infliximab

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Topical InfliximabExperimental Treatment1 Intervention

Additionally to standard treatment, patients with all inclusive criteria and none exclusive criteria will be included in the therapeutic group and will receive topical infliximab QID for 4 weeks.

Group II: Observational groupActive Control1 Intervention

Patients with all inclusive criteria and one exclusive criteria will receive the standard treatment, without topical infliximab.

0 / 10Eligibility 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

Corneal melt is a severe condition characterized by the thinning of the cornea, which can lead to ocular perforation and blindness. Treatments like infliximab, a TNF-alpha inhibitor, work by reducing inflammation and preventing further corneal degradation. TNF-alpha inhibitors block the activity of tumor necrosis factor-alpha, a cytokine involved in systemic inflammation, thereby reducing the inflammatory response that contributes to corneal melt. This is crucial for patients as it helps to stabilize the cornea, prevent further damage, and preserve vision.

Chronic Non-infectious Uveitis in Patients with Juvenile Idiopathic Arthritis.Effectiveness of topical infliximab in a mouse model of experimental dry eye.