[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518681":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":66,"collaborators":43,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":43,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":43,"enrollmentInfo":80,"targetDuration":43,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary retinal detachment, Phakic group","EXPERIMENTAL","Phakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included.\n\nPatients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.",[13],"Drug: Netarsudil Ophthalmic",{"label":15,"type":10,"description":16,"interventionNames":17},"Primary retinal detachment, Pseudophakic group","Pseudophakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included.\n\nPatients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Secondary retinal detachment, Phakic group","Phakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included.\n\nPatients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Secondary retinal detachment, Pseudophakic group","Pseudophakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included.\n\nPatients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Netarsudil Ophthalmic","Topical administration of Netarsudil",[9,15,19,23],[33],"Rhopressa",[35],{"name":36,"affiliation":37,"role":38},"Leo Kim, MD, PhD","Massachusetts Eye and Ear","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","6175237900",null,"Leo_Kim@meei.harvard.edu",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":43},"Center for Clinical Research Operations (CCRO)","6175736060",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Mass Eye and Ear","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-71.05977,42.35843,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":43,"phoneExt":43,"email":43},"Leo A Kim, MD. PhD",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":69,"oldNameTitle":43,"oldOrganization":43},"Leo Am Kim, M.D.","Assistant Professor of Ophthalmology","Massachusetts General Hospital","100518681","phase-1-topical-netarsudil-for-the-prevention-of-proliferative-vitreoretinopathy-in-patients-with-retinal-detachment-100518681",false,"NCT06033703","Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment","Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Primary Rhegmatogenous Detachments and Retinal Detachment Due to Proliferative Vitreoretinopathy or Open-Globe Injury: A Phase I\u002FII Clinical Trial","The primary rhegmatogenous detachment cohort will have the following selection criteria:\n\nInclusion criteria:\n\n* Patients \\> 18 years old\n* Patients presenting for primary rhegmatogenous retinal detachment repair within 28 days of symptom onset\n* Patients undergoing vitrectomy or vitrectomy with scleral buckle\n\nExclusion criteria:\n\n* Patient unable to give consent\n* Patient unable to follow-up\n* Prior history of retinal detachment incisional surgery in presenting eye\n* Prior history of open globe injury to presenting eye\n* Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery, actively on glaucoma medication\n* Prior history of corneal disease, or history of corneal edema\n* Patient already on topical netarsudil in presenting eye\n* Patient without natural lens or intraocular lens implant (I.e., aphakic patients)\n* Patients with intraocular pressure \\\u003C8mm Hg in operative eye\n* Active or chronic or recurrent uncontrolled ocular or systemic disease\n* Active or history of chronic or recurrent inflammatory eye disease\n* Diagnosis of proliferative diabetic retinopathy\n* Signs of ocular infection at presentation in either eye\n* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively\n* Inability to use\u002F apply topical eye drops\n\nThe proliferative vitreoretinopathy cohort will have the following selection criteria:\n\nInclusion criteria:\n\n* Patients \\> 18 years old\n* Patient presenting with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma\n* Patients undergoing vitrectomy or vitrectomy with scleral buckle\n\nExclusion criteria:\n\n* Patient unable to give consent\n* Patient unable to follow-up\n* Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery\n* Patient already on topical netarsudil in presenting eye\n* Patients with intraocular pressure \\\u003C8mm Hg in operative eye\n* Active or chronic or recurrent uncontrolled ocular or systemic disease\n* Active or history of chronic or recurrent inflammatory eye disease\n* Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in operative eye\n* Signs of ocular infection at presentation in either eye\n* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively\n* Inability to use\u002F apply topical eye drops\n* No Light Perception vision in operative eye\n* Failure to achieve intraoperative reattachment",true,"ALL","18 Years",{"count":81,"type":82},48,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This study has two main objectives. The first objective is to study the pharmacokinetics of topical netarsudil administration in the posterior segment of the eye, where netarsudil must exert its effect in order to prevent formation of tractional membranes.\n\nThe second objective is to assess the safety profile of topical netarsudil in the pre- and post-operative periods. A secondary objective of the study is to begin to assess signs of efficacy in preventing formation of tractional membranes post-operatively.",[89,90],"Rhegmatogenous Retinal Detachment","Proliferative Vitreoretinopathy",[92,93,94,95,96],"Vitrectomy","Netarsudil","Pharmacokinetics","Safety","Efficacy","2025-10-24",{"date":99,"type":100},"2025-10-28","ACTUAL",{"date":102,"type":100},"2025-01-14",{"date":104,"type":82},"2026-12",{"name":5,"class":6},1]