Using infliximab eye drops to prevent glaucoma after corneal transplant surgery
Topical Infliximab in Eyes With Penetrating Keratoplasty
This study is testing if infliximab eye drops can help prevent glaucoma in patients after they have corneal transplant surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05180994 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are undergoing their first corneal transplant surgery.
Not a fit: Patients with advanced glaucoma, active ocular infections, or a history of certain systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of glaucoma in patients undergoing corneal transplant surgery.
How similar studies have performed: While the use of infliximab in other forms has been studied, this specific approach of topical administration for preventing glaucoma post-PKP is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
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 — Chum
- Study coordinator: Zobelle Tchouaga
- Email: zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.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.