Recruiting
Phase 1
Phase 2

Topical Infliximab

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05180994

Conditions

Glaucoma Following Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Topical infliximab

No topical infliximab

Study Details

Brief 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.

Conditions

Glaucoma Following Surgery

Study ID

NCT05180994

Start date

May 1, 2022

Status verified date

Apr, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Topical infliximab following PKP surgery

Additionally to standard post-operative regimen, patients who will be undergoing their first PKP surgery and who meet all inclusion and no exclusion criteria will be included in the experimental group. These patients will administer topical infliximab four times per day for 3 months.

active comparator: No topical infliximab following PKP surgery

Patients who will be undergoing their first PKP surgery, but who are not qualified to receive infliximab or who refuse to receive infliximab, will be included in the control group. These patients will only administer the standard post-operative regimen following their PKP surgery and will not administer topical infliximab. They will be followed with the same follow-up schedule, questionnaires, examinations and non-invasive tests (excluding lab work) as patients in the interventional group.

Interventions

Topical infliximab

Infliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months.

No topical infliximab

No treatment with infliximab.

Primary outcome measure

  • Complications associated to PKP surgery [ Time Frame: 6 months ]
  • Complications associated to infliximab use [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Zobelle Tchouaga

514 890-8000zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Zobelle Tchouaga

514 890-8000zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-27.