Topical Infliximab in Eyes With Penetrating Keratoplasty

NCT05180994 | Recruiting Phase 1 DMC

• 2 other identifiers: CE 21.232MP-02-2021-9824
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Complications associated to PKP surgery

  Number and type of complications associated to PKP surgery (graft loss, infectious keratitis, graft failure, corneal melting…)

  6 months

• Complications associated to infliximab use

  Number and type of complications associated with infliximab use (serious infections, allergic reactions, heart failure, blood problems, nervous system disorders, malignancies…; these complications have been observed with intravenous infliximab administration).

  6 months

Secondary Outcomes (8)

• Mean retinal nerve fiber thickness

  6 months

• Occurrence of glaucoma

  6 months

• Best Corrected Visual Acuity (BCVA)

  6 months

• Ocular surface symptoms

  6 months

• Quantification of ocular surface inflammation

  6 months

Study Arms (2)

Topical infliximab following PKP surgery

EXPERIMENTAL

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.

Drug: Topical infliximab

No topical infliximab following PKP surgery

ACTIVE COMPARATOR

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.

Other: No topical infliximab

Interventions

Topical infliximab DRUG

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

Also known as: Remicade

Topical infliximab following PKP surgery

No topical infliximab OTHER

No treatment with infliximab.

No topical infliximab following PKP surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Fonds de recherche en ophtalmologie de l'Université de Montréal: collaborator
• Maisonneuve-Rosemont Hospital: collaborator
• Niagara Health System: collaborator
• Prism Eye Institute: collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Interventions

Infliximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Marie-Claude Robert, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zobelle Tchouaga

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 6, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)