NCT05180994|RecruitingPhase 1/2DMC
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Sponsor study identifier
Secondary identifiers
OTHER · Centre Hospitalier de l'Université de Montréal
interventional
50
1 country
1
Study Start
May 1, 2022
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2021
Actual (reported)January 6, 2022
Actual (reported)May 1, 2022
Actual (reported)March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
Infliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months.
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
Marie-Claude Robert, MD
CHUM
First Submitted
November 29, 2021
First Posted
January 6, 2022
Study Start
May 1, 2022
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema
Contact the study team to confirm eligibility.
Study Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 27, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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