[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557704":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":42,"locations":48,"responsibleParty":65,"collaborators":35,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":35,"enrollmentInfo":78,"targetDuration":35,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":51,"whyStopped":35,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Cincinnati Eye Institute, Southwest Ohio","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","SHAM_COMPARATOR","receiving no methotrexate",[13],"Drug: Sham Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Injection group","EXPERIMENTAL","receiving standard surgery without intraoperative methotrexate followed by postoperative 400µg intravitreal methotrexate injections 1, 3, 6, and 10 weeks after surgery.",[19],"Drug: Methotrexate Injection",{"label":21,"type":16,"description":22,"interventionNames":23},"Infusion Group","receiving surgery with intraoperative intraocular methotrexate infusion as described above and postoperative sham injections.",[24],"Drug: Methotrexate Infusion",{"label":26,"type":16,"description":27,"interventionNames":28},"Combined Infusion\u002FInjection group","receiving both intraoperative intraocular methotrexate infusion and postoperative 400µg intravitreal methotrexate injections 1, 3, 6, and 10 weeks after surgery.",[19,24],[30,36,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Methotrexate Injection","Methotrexate injection",[26,15],null,{"type":31,"name":37,"description":37,"armGroupLabels":38,"otherNames":35},"Methotrexate Infusion",[26,21],{"type":31,"name":40,"description":40,"armGroupLabels":41,"otherNames":35},"Sham Injection",[9],[43],{"name":44,"role":45,"phone":46,"phoneExt":35,"email":47},"Christopher Riemann, MD","CONTACT","513-708-1979","criemann@cvphealth.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Cincinnati Eye Institute","RECRUITING","Cincinnati","Ohio","45242","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-84.51439,39.12711,{"lat":61,"lon":60},[64],{"name":44,"role":45,"phone":46,"phoneExt":35,"email":47},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Christopher Riemann","Principal Investigator","100557704","phase-2-prevention-of-proliferative-vitreoretinopathy-with-intravitreal-methotrexate-in-primary-retinal-detachment-repair-fixer-trial-100557704",false,"NCT06541574","Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial","FIXER","Inclusion Criteria:\n\n• Any adult patient, age \\> 18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent.\n\nExclusion Criteria:\n\n* Age \\<18 years-old\n* Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit.\n* History of endophthalmitis, ruptured globe or significant trauma in the affected eye\n* Chronic retinal detachment (symptoms \\> six weeks)\n* Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded.\n* Presence of Grade C PVR: full thickness retinal folds or subretinal bands\n* Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate\n* Patients with diminished mental capacity precluding their ability to give informed consent.","ALL","18 Years",{"count":79,"type":80},860,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","I. Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial\n\n* Today's Date: September 18, 2023 II. Principal Investigator\n* Principal Investigator: Christopher D. Riemann, M.D. (Cincinnati Eye Institute)\n* Email: criemann@cvphealth.com, Phone: 513-708-1979\n\nV. Research Summary\n\nPurpose:\n\nTo evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair.\n\nMethods:\n\nInclusion Criteria:\n\n• Any adult patient, age ≥18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent.\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit.\n* History of endophthalmitis, ruptured globe or significant trauma in the affected eye\n* Chronic retinal detachment (symptoms greater than or equal to six weeks)\n* Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded.\n* Presence of Grade C PVR: full thickness retinal folds or subretinal bands\n* Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate\n* Patients with diminished mental capacity precluding their ability to give informed consent.\n\nStudy Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1:1:1:1 fashion. All attending surgeons and patients will be masked to group randomization. Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institute's pharmacist, Deepali Chachare. Group A will consist of ≥ 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate (40mg\u002F500mL BSS), and methotrexate intravitreal injections (400mcg\u002F0.05mL) at postoperative weeks 1, 3, 6, and 10. Group B will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10. Group C will consist of ≥ 150 patients receiving a balanced salt solution infusion without methotrexate, and methotrexate injections at postoperative weeks 1, 3, 6, and 10. Group D will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion without methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10.",[86,87],"Proliferative Vitreoretinopathy","Rhegmatogenous Retinal Detachment",[86,87],"2024-09-05",{"date":91,"type":92},"2024-09-19","ACTUAL",{"date":94,"type":92},"2024-03-01",{"date":96,"type":80},"2026-06",{"name":5,"class":6},1]