[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579009":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":37,"locations":46,"responsibleParty":73,"collaborators":36,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":36,"enrollmentInfo":85,"targetDuration":36,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":99,"whyStopped":36,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravitreal topotecan with retinal detachment surgery","EXPERIMENTAL","Intravitreal topotecan 8 µg\u002F0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively.",[13,14],"Drug: Intravitreal topotecan","Procedure: Retinal detachment surgery",{"label":16,"type":17,"description":18,"interventionNames":19},"Retinal detachment surgery","ACTIVE_COMPARATOR","Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intravitreal topotecan","Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and\u002For scleral buckling) and one week after surgery, for a total of two injections.",[9],[27],"Topotecan",{"type":29,"name":16,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and\u002For scleral buckling).",[9,16],[33,34,35],"Pars plana vitrectomy","Pneumatic retinopexy","Scleral buckling",null,[38,43],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Rajeev H Muni, MD MSc FRCSC","CONTACT","416-867-7411","rajeev.muni@utoronto.ca",{"name":44,"role":40,"phone":41,"phoneExt":36,"email":45},"Marko M Popovic, MD MPH FRCSC","marko.popovic@mail.utoronto.ca",[47,62],{"facility":48,"status":36,"city":49,"state":50,"zip":36,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"St. Michael's Hospital","Toronto","Ontario","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-79.39864,43.70643,{"lat":57,"lon":56},[60,61],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},{"name":39,"role":40,"phone":36,"phoneExt":36,"email":36},{"facility":63,"status":36,"city":49,"state":50,"zip":36,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Sunnybrook Health Sciences Centre",{"type":54,"coordinates":65},[56,57],{"lat":57,"lon":56},[68,72],{"name":69,"role":40,"phone":70,"phoneExt":36,"email":71},"Peter J Kertes, MD CM FRCSC","416-480-4244","peter.kertes@sunnybrook.ca",{"name":69,"role":40,"phone":36,"phoneExt":36,"email":36},{"type":74,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100579009","phase-2-intravitreal-topotecan-for-prevention-or-treatment-of-proliferative-vitreoretinopathy-in-retinal-detachment-100579009",false,"NCT06818721","Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment","Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study","TOPO-PT","Inclusion Criteria:\n\n1. Patients aged 18 years and older\n2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and\u002For scleral buckling for rhegmatogenous retinal detachment\n3. Patients who are voluntarily able and willing to participate\n\nPatients undergoing combined phacoemulsification and pars plana vitrectomy and\u002For scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.\n\nExclusion Criteria:\n\n1. Patients with a history of exudative retinal detachment\n2. Patients with severe non-proliferative or proliferative diabetic retinopathy\n3. Patients with other planned ocular surgery following pars plana vitrectomy\n4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study\n5. Patients with pre-existing bone marrow suppression or cytopenias\n6. Patients with pre-existing interstitial lung disease","ALL","18 Years",{"count":86,"type":87},394,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.",[93,94],"Retinal Detachment Rhegmatogenous","Proliferative Vitreoretinopathy",[96,97,98],"topotecan","proliferative vitreoretinopathy","rhegmatogenous retinal detachment","NOT_YET_RECRUITING","2025-03-03",{"date":102,"type":103},"2025-03-06","ACTUAL",{"date":105,"type":87},"2025-03",{"date":107,"type":87},"2027-04",{"name":5,"class":6},2]