Using infliximab eye drops to prevent glaucoma after corneal transplant surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of topical infliximab eye drops in preventing glaucoma following penetrating keratoplasty (PKP) surgery. A total of 50 patients undergoing their first PKP will be recruited, with half receiving infliximab drops post-operatively and the other half serving as a control group. The infliximab drops will be administered four times daily for three months, followed by a three-month monitoring period. The study aims to determine if this new delivery method can effectively reduce the incidence of inflammatory glaucoma in these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Marie-Claude Robert, MD — Chum
• Study coordinator: Zobelle Tchouaga
• Email: zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca
• Phone: 514 890-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.