Topical Infliximab for Sterile Corneal Melt

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    12
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 24 February 2022

Summary

Corneal melt is a complication that could affect very ill eyes and lead to the thinning of the cornea (the clear window covering of the eyes). This thinning can lead to severe consequences such as the leakage of the liquid inside the eye (ocular perforation), or even blindness. Corneal melt can be caused by certain infections or as a sterile process. This project only includes patients with a sterile corneal melt (without an infection) caused by diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.

Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this situation, infliximab was used intravenous (using veins) in order to treat the whole body.

This study's hypothesis is that infliximab can safely be used as eye drops for the treatment of sterile corneal melt.

Description

This is an unmasked, prospective, single-center trial of twelve patients with sterile corneal melt and an underlying auto-immune or inflammatory disease, such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.

The aim of this phase I study is to evaluate the safety and tolerability of topical infliximab 10mg/ml eye drops for the treatment of corneal melt. As such, six (6) subjects will be recruited in the experimental treatment study and six (6) subjects will be enrolled in the parallel observational study. Indeed, candidates having all inclusion criteria but one exclusion criteria (which are contraindication to infliximab use), will be recruited in the observational study, will receive the standard treatment without infliximab.

During the treatment period, subjects in the therapeutic study will receive topical infliximab 10mg/ml four (4) times per day for four (4) weeks. In order to determine the safety profile, potential side effects as well as the course of the disease, subjects will be monitored while on the study medication as well as for 8 weeks following discontinuation of the drug. The ophthalmological follow-up will be identical in the two groups. However, only subjects enrolled in the experimental treatment study will receive additional laboratory tests. The total study duration for each patient will be 12 weeks.

In terms of statistical analysis, the investigators will focus on describing the outcome measured in the study. For instance, the investigators will describe the number and proportion of side effects, the number of patients with a quiescent corneal melt at 4 weeks and the patients who required a tectonic surgery at 12 weeks post-treatment. The investigators will report the average and standard of deviation of the OSDI score, the epithelial deficit surface as well as the minimal corneal thickness. Moreover, the investigators will perform exploratory statistical analysis in order to study the disease course of each subject and comparing the addition of infliximab to the standard.

Details
Condition Sterile Corneal Melt
Treatment Topical Infliximab
Clinical Study IdentifierNCT02987686
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 to 80 years
Any degree of active sterile corneal melting , as documented by slit-lamp examination, showing an epithelial defect and stromal thinning
Negative work-up for local and systemic infectious causes
Negative corneal cultures (may show growth of common contaminants)
Capable of providing informed consent
Capable of administering eye drops either themselves or through a caregiver

Exclusion Criteria

Any active ocular or systemic infection including active or latent tuberculosis, histoplasmosis, coccidiomycosis, cytomegalovirus, pneumocystosis, aspergillosis, or hepatitis B
History of neoplasia diagnosed within the last 5 years
Demyelinating disease
Diabetes
Congestive heart failure
Significant anomalies on complete blood count, creatinine or hepatic enzymes
Pregnancy or breast feeding
Allergy to infliximab or to the drug vehicle (Refresh liquigel)
Past or present use of anti-TNF- medications or human interleukin-1 receptor antagonist (anakinra, IL-1Ra)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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