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Anti-TNF-alpha Antibody

Topical Infliximab for Glaucoma

Phase 1 & 2

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 between 18 and 80 years

Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient

Must not have

Past corneal transplant (any technique)

Active ocular infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the anti-inflammatory drug infliximab can prevent the occurrence of glaucoma after cornea surgery.

Who is the study for?

This trial is for adults aged 18-80 undergoing their first corneal transplant surgery who can consent and manage eye medication (or have someone to help). It's not for those with active eye infections, past transplants, severe glaucoma or macular disease, systemic infections, recent cancer, demyelinating diseases, diabetes or heart failure (NYHA class III/IV), pregnant/breastfeeding women, infliximab allergies, abnormal blood counts or liver tests.

What is being tested?

The study aims to test if using infliximab eye drops after corneal transplant surgery is safe and can prevent glaucoma. Participants will either receive the topical infliximab drops or no treatment as a comparison. The main focus is on safety and effectiveness in preventing inflammation that could lead to glaucoma.

What are the potential side effects?

Potential side effects of topical infliximab may include local irritation in the eyes such as redness or discomfort. Since it's an anti-inflammatory drug used systemically for other conditions too, there might be risks of systemic side effects like infection risk increase.

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 medication or have someone who can do it for me.

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I am having my first corneal transplant surgery.

Exclusion Criteria

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

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I have had a corneal transplant in the past.

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I currently have an eye infection.

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

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I have diabetes or heart failure that is either controlled or not.

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I do not have any active or latent infections like TB or hepatitis B.

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I have used anti-inflammatory medication like anti-TNF-α.

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I was diagnosed with cancer within the last 5 years.

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I have advanced glaucoma or a serious condition affecting my retina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Complications associated to PKP surgery

Complications associated to infliximab use

Secondary study objectives

Best Corrected Visual Acuity (BCVA)

Epithelial healing time

Incidence of epithelial keratitis

+5 more

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 infliximab following PKP surgeryExperimental Treatment1 Intervention

Additionally to standard post-operative regimen, patients who will be undergoing their first PKP surgery and who meet all inclusion and no exclusion criteria will be included in the experimental group. These patients will administer topical infliximab four times per day for 3 months.

Group II: No topical infliximab following PKP surgeryActive Control1 Intervention

Patients who will be undergoing their first PKP surgery, but who are not qualified to receive infliximab or who refuse to receive infliximab, will be included in the control group. These patients will only administer the standard post-operative regimen following their PKP surgery and will not administer topical infliximab. They will be followed with the same follow-up schedule, questionnaires, examinations and non-invasive tests (excluding lab work) as patients in the interventional group.

0 / 11Eligibility criteria met