Topical Infliximab for Sterile Corneal Melt

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborator: Fonds de recherche en ophtalmologie de l'Université de Montréal
• Treatments: Infliximab

Criteria

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-α medications or human interleukin-1 receptor antagonist (anakinra, IL-1Ra)