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Topical Infliximab in Eyes With Penetrating Keratoplasty

RecruitingPhase 1, Phase 2Ages 18 Years - 80 YearsAllCentre hospitalier de l'Université de Montréal (C…
NCT05180994 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Topical infliximab
  • No topical infliximab
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Where

1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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