Topical Infliximab for Sterile Corneal Melt

NCT02987686 | Completed Phase 1 DMC

• 1 other identifier: CE16.221
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sterile Corneal Melt

Keywords

Topical Infliximab; Cornea; Keratolysis

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number and type of adverse events

  12 weeks

• Percentage of patients finishing 4 weeks of infliximab use

  Percentage of patients finishing 4 weeks of infliximab use

  4 weeks

Secondary Outcomes (7)

• Visual Acuity

  4 and 12 weeks

• Ocular surface symptoms as assessed by ocular disease index score

  4 and 12 weeks

• Conjunctival hyperemia using a slit-lamp photographs

  4 and 12 weeks

• Corneal thickness as measured by anterior segment optical coherence tomography

  4 weeks

• Surface area of the corneal melt using a slit-lamp photographs

  4 weeks

Study Arms (2)

Topical Infliximab

EXPERIMENTAL

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.

Drug: Topical Infliximab

Observational group

NO INTERVENTION

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

Interventions

Topical Infliximab DRUG

Aside from the standard treatment, patients will receive topical infliximab ( 10mg/ml) four (4) time per day for four (4) weeks.

Also known as: Remicade

Topical Infliximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X3E4, Canada

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Marie-Claude Robert, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: December 9, 2016
• Study Start: September 6, 2017
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)