Topical Infliximab for the Treatment of Sterile Corneal Melt

Who is this study for? Adult patients with an Epithelial Defect and Stromal Thinning
What treatments are being studied? Infliximab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
Marie-Claude Robert, MD
marie-claude.robert.2@umontreal.ca
514 890-8000
Backup
Marie-Catherine Tessier
marie-catherine.tessier.chum@ssss.gouv.qc.ca
514 890-8000
Time Frame
Start Date: 2017-09-06
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Topical Infliximab
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.
No_intervention: Observational group
Patients with all inclusive criteria and one exclusive criteria will receive the standard treatment, without topical infliximab.
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Fonds de recherche en ophtalmologie de l'Université de Montréal

This content was sourced from clinicaltrials.gov

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