[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453166":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":62,"collaborators":64,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":32,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":32,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":32,"overallStatus":48,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Topical infliximab",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: No topical infliximab",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Topical infliximab","Infliximab eye drops (10mg\u002Fml) administered four (4) times per day for three (3) months.",[9],[27],"Remicade",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"No topical infliximab","No treatment with infliximab.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Marie-Claude Robert, MD","CHUM","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Zobelle Tchouaga","CONTACT","514 890-8000","11553","zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Centre Hospitalier de l'Université de Montréal","RECRUITING","Montreal","Quebec","H2X 3E4","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-73.58781,45.50884,{"lat":58,"lon":57},[61],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[65,67,69,71,73],{"name":66,"class":6},"Fonds de recherche en ophtalmologie de l'Université de Montréal",{"name":68,"class":6},"Maisonneuve-Rosemont Hospital",{"name":70,"class":6},"Niagara Health System",{"name":72,"class":6},"Prism Eye Institute",{"name":74,"class":6},"Ottawa Hospital Research Institute","100453166","phase-1-topical-infliximab-in-eyes-with-penetrating-keratoplasty-100453166",false,"NCT05180994","Topical Infliximab in Eyes With Penetrating Keratoplasty","Inclusion Criteria:\n\n* Age between 18 and 80 years;\n* First corneal transplant surgery;\n* Capable of providing informed consent;\n* Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.\n\nExclusion Criteria:\n\n* Active ocular infection;\n* Past corneal transplant (any technique);\n* Advanced glaucoma or macular disease;\n* Active or latent systemic infection (tuberculosis, histoplasmosis, coccidioidomycosis, cytomegalovirus, pneumocystis, aspergillosis or hepatitis B);\n* Malignancy diagnosed in the past 5 years (any kind);\n* Demyelinating disease;\n* History or current diabetes mellitus (controlled or uncontrolled) or heart failure (New York Heart Association class III or IV);\n* Pregnancy or breastfeeding;\n* Allergy to infliximab or to a compound of its topical formulation;\n* Significant anomaly of complete blood count or hepatic enzymes;\n* Current or anterior use of anti-TNF-α medication or other anti-inflammatory biologics.","ALL","18 Years","80 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","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.",[93],"Glaucoma Following Surgery","2026-04-23",{"date":96,"type":97},"2026-04-27","ACTUAL",{"date":99,"type":97},"2022-05-01",{"date":101,"type":86},"2028-03-01",{"name":5,"class":6},1]