RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Topical Infliximab in Eyes With Penetrating Keratoplasty
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age between 18 and 80 years;
- First corneal transplant surgery;
- Capable of providing willing to sign a consent form;
- Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Topical infliximab
Infliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months.
OTHER
No topical infliximab
No treatment with infliximab.
Locations (1)
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada