RecruitingPhase 1Phase 2NCT05180994
Topical Infliximab in Eyes With Penetrating Keratoplasty
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
50 participants
Start Date
May 1, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria11
- 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.
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Interventions
DRUGTopical infliximab
Infliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months.
OTHERNo topical infliximab
No treatment with infliximab.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05180994