Topical Infliximab in Eyes With Penetrating Keratoplasty

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Penetrating keratoplasty is a cornea surgery involving several inflammatory complications, of which the most important is glaucoma. Researchers wish to determine whether it is safe to administer infliximab (an anti-inflammatory drug) eye drops after surgery, and whether this eye drop could prevent the occurrence of glaucoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Fonds de recherche en ophtalmologie de l'Université de Montréal; Maisonneuve-Rosemont Hospital; Niagara Health System; Ottawa Hospital Research Institute; Prism Eye Institute
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• Age between 18 and 80 years;

• First corneal transplant surgery;

• Capable of providing informed consent;

• Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.

Exclusion Criteria:

• Active ocular infection;

• Past corneal transplant (any technique);

• Advanced glaucoma or macular disease;

• Active or latent systemic infection (tuberculosis, histoplasmosis, coccidioidomycosis, cytomegalovirus, pneumocystis, aspergillosis or hepatitis B);

• Malignancy diagnosed in the past 5 years (any kind);

• Demyelinating disease;

• History or current diabetes mellitus (controlled or uncontrolled) or heart failure (New York Heart Association class III or IV);

• Pregnancy or breastfeeding;

• Allergy to infliximab or to a compound of its topical formulation;

• Significant anomaly of complete blood count or hepatic enzymes;

• Current or anterior use of anti-TNF-α medication or other anti-inflammatory biologics.