Topical Infliximab for treating corneal melt
Topical Infliximab for the Treatment of Sterile Corneal Melt
PHASE1 · Centre hospitalier de l'Université de Montréal (CHUM) · NCT02987686
This study is testing if eye drops containing infliximab can safely help people with a serious eye condition called corneal melt that could lead to blindness.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Drugs / interventions | infliximab |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT02987686 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of topical infliximab eye drops for patients suffering from sterile corneal melt, a serious condition that can lead to blindness. The study involves twelve participants, with six receiving the experimental treatment and six in a parallel observational group. Participants will use the eye drops four times daily for four weeks, with follow-up assessments to monitor safety and disease progression. The trial aims to determine if infliximab can be effectively used in this localized form to treat corneal melt caused by autoimmune diseases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with active sterile corneal melting and an underlying autoimmune or inflammatory disease.
Not a fit: Patients with active ocular or systemic infections, certain medical histories, or contraindications to infliximab will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, localized therapy for patients with sterile corneal melt, potentially preventing severe complications like blindness.
How similar studies have performed: While the use of infliximab has been explored in systemic treatments, this specific application as topical eye drops for corneal melt is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Marie-Claude Robert, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Marie-Claude Robert, MD
- Email: marie-claude.robert.2@umontreal.ca
- Phone: 514 890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sterile Corneal Melt, Topical Infliximab, Cornea, Keratolysis