[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482508":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":180,"collaborators":25,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":184,"sex":190,"minAge":191,"maxAge":25,"enrollmentInfo":192,"targetDuration":25,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Implant Arm","EXPERIMENTAL","Participants will have the implant (pre-filled intraoperatively with ranibizumab 100 mg\u002FmL) surgically inserted on Day 1. After Day 1, participants in the implant arm will attend monthly study visits, and receive implant refill-exchanges with ranibizumab 100 mg\u002FmL at Week 24 and Week 48. At the Week 48 study visit, participants will move to the long -term extension phase of the study and continue receiving refill-exchanges Q24W until the end of study. Participants will attend monthly visits up to Week 96 and bi-monthly visits thereafter, followed by visits every two months until study completion.",[13],"Device: PDS With Ranibizumab (100 mg\u002FmL)",{"label":15,"type":10,"description":16,"interventionNames":17},"IVT Arm","Participants will receive IVT ranibizumab 0.5 mg injections starting on Day 1. Participants will receive IVT ranibizumab 0.5 mg Q4W until Week 44. At the Week 48 study visit, participants will receive the PDS implant (pre-filled intraoperatively with ranibizumab 100 mg\u002FmL), move to the long-term extension phase of the study and receive Q24W refill exchanges until the end of study. If participants are unable to attend the Week 48 visit due to extenuating circumstances, they should return no later than the next scheduled visit (Week 52), when they will receive the PDS implant. Participants will attend monthly visits up to Week 96 and bi-monthly visits thereafter, followed by visits every two months until study completion.",[13,18],"Drug: Ranibizumab (10 mg\u002FmL)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","PDS With Ranibizumab (100 mg\u002FmL)","Participants randomized to the implant arm will have the implant (filled prior to implantation with approximately 20 microliters (μL) of the 100 mg\u002FmL formulation of ranibizumab \\[approximately 2 mg dose of ranibizumab\\]) surgically inserted in the study eye at the Day 1 visit following their randomization visit, or at Week 48 visit for participants randomized to the IVT arm. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed 24-week intervals.",[15,9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","Ranibizumab (10 mg\u002FmL)","Participants in the IVT arm will receive their first IVT injection of 50 μL of the 10 mg\u002FmL ranibizumab (0.5 mg dose) at the Day 1 visit, which will occur at the conclusion of the randomization visit. Afterwards, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg\u002FmL formulation Q4W at each scheduled study visit until Week 44 and bi-monthly visits thereafter, followed by visits every two months until study completion.",[15],[32],{"name":33,"affiliation":5,"role":34},"Clinical Trials","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Reference Study ID Number: YR42983 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":25},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[44,57,64,69,78,84,93,102,111,120,127,136,145,154,163,172],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"Peking Union Medical College Hospital","RECRUITING","Beijing","100032","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},{"facility":58,"status":59,"city":47,"state":25,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":63,"contacts":25},"Beijing Hospital","WITHDRAWN","100730",{"type":52,"coordinates":62},[54,55],{"lat":55,"lon":54},{"facility":65,"status":46,"city":47,"state":25,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":68,"contacts":25},"Beijing Tongren Hospital",{"type":52,"coordinates":67},[54,55],{"lat":55,"lon":54},{"facility":70,"status":46,"city":71,"state":25,"zip":72,"country":49,"countryCode":50,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"West China Hospital, Sichuan University","Chengdu","610041",{"type":52,"coordinates":74},[75,76],104.06667,30.66667,{"lat":76,"lon":75},{"facility":79,"status":46,"city":71,"state":25,"zip":80,"country":49,"countryCode":50,"cosmosGeoPoint":81,"geoPoint":83,"contacts":25},"Sichuan Provincial People's Hospital","610072",{"type":52,"coordinates":82},[75,76],{"lat":76,"lon":75},{"facility":85,"status":46,"city":86,"state":25,"zip":87,"country":49,"countryCode":50,"cosmosGeoPoint":88,"geoPoint":92,"contacts":25},"Zhongshan Ophthalmic Center, Sun Yat-sen University","Guangzhou","510060",{"type":52,"coordinates":89},[90,91],113.25,23.11667,{"lat":91,"lon":90},{"facility":94,"status":46,"city":95,"state":25,"zip":96,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":101,"contacts":25},"The Second Affiliated Hospital of Harbin Medical University","Harbin","150081",{"type":52,"coordinates":98},[99,100],126.65,45.75,{"lat":100,"lon":99},{"facility":103,"status":46,"city":104,"state":25,"zip":105,"country":49,"countryCode":50,"cosmosGeoPoint":106,"geoPoint":110,"contacts":25},"Qingdao Eye Hospital of Shandong First Medical University","Qingdao","266109",{"type":52,"coordinates":107},[108,109],120.38042,36.06488,{"lat":109,"lon":108},{"facility":112,"status":46,"city":113,"state":25,"zip":114,"country":49,"countryCode":50,"cosmosGeoPoint":115,"geoPoint":119,"contacts":25},"Shanghai First People's Hospital","Shanghai","200080",{"type":52,"coordinates":116},[117,118],121.45806,31.22222,{"lat":118,"lon":117},{"facility":121,"status":122,"city":113,"state":25,"zip":123,"country":49,"countryCode":50,"cosmosGeoPoint":124,"geoPoint":126,"contacts":25},"Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","ACTIVE_NOT_RECRUITING","200092",{"type":52,"coordinates":125},[117,118],{"lat":118,"lon":117},{"facility":128,"status":46,"city":129,"state":25,"zip":130,"country":49,"countryCode":50,"cosmosGeoPoint":131,"geoPoint":135,"contacts":25},"The First Affiliated Hospital of China Medical University","Shenyang","110001",{"type":52,"coordinates":132},[133,134],123.43278,41.79222,{"lat":134,"lon":133},{"facility":137,"status":46,"city":138,"state":25,"zip":139,"country":49,"countryCode":50,"cosmosGeoPoint":140,"geoPoint":144,"contacts":25},"Shanxi Eye Hospital","Taiyuan","030002",{"type":52,"coordinates":141},[142,143],112.56028,37.86944,{"lat":143,"lon":142},{"facility":146,"status":46,"city":147,"state":25,"zip":148,"country":49,"countryCode":50,"cosmosGeoPoint":149,"geoPoint":153,"contacts":25},"Tianjin Medical University Eye Hospital","Tianjin","300070",{"type":52,"coordinates":150},[151,152],117.17667,39.14222,{"lat":152,"lon":151},{"facility":155,"status":46,"city":156,"state":25,"zip":157,"country":49,"countryCode":50,"cosmosGeoPoint":158,"geoPoint":162,"contacts":25},"Eye Hospital, Wenzhou Medical University","Wenzhou","325027",{"type":52,"coordinates":159},[160,161],120.66682,27.99942,{"lat":161,"lon":160},{"facility":164,"status":46,"city":165,"state":25,"zip":166,"country":49,"countryCode":50,"cosmosGeoPoint":167,"geoPoint":171,"contacts":25},"Tongji Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","430030",{"type":52,"coordinates":168},[169,170],114.26667,30.58333,{"lat":170,"lon":169},{"facility":173,"status":46,"city":174,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":175,"geoPoint":179,"contacts":25},"Xi'an People's Hospital (Xi'an Fourth Hospital)","Xi'an",{"type":52,"coordinates":176},[177,178],108.92861,34.25833,{"lat":178,"lon":177},{"type":181,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100482508","phase-3-a-study-of-the-efficacy-safety-and-pharmacokinetics-pk-of-the-port-delivery-system-with-ranibizumab-pds-in-chinese-participants-with-neovascular-age-related-macular-degeneration-namd-100482508",false,"NCT05562947","A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)","A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration","HUTONG","Inclusion Criteria:\n\n* Initial diagnosis of nAMD within 9 months prior to the screening visit\n* Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard-of-care (SOC) within 6 months prior to the screening visit\n* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis\n* Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit\n* BCVA of 34 letters or better (20\u002F200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters\n* All subtypes of nAMD lesions are permissible\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images\n\nExclusion Criteria:\n\nA. Prior Ocular Treatment Study Eye\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD\n* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy\n* Previous treatment with corticosteroid IVT injection or corticosteroid implants\n* Previous intraocular device implantation (not including intraocular lens implants)\n* Previous laser (any type) used for age-related macular degeneration (AMD) treatment\n* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit\n* Prior treatment with IVT treatments for geographic atrophy\n* Concurrent conjunctival, Tenon's capsule, and\u002For scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant\n\nEither Eye\n\n* Prior treatment with brolucizumab\n* Prior gene therapy for nAMD or other ocular diseases\n* Previous participation in any ocular disease studies of investigational drugs and\u002For devices, within 3 months or five elimination half-lives of the investigational therapy, whichever is longer, preceding the screening visit\n\nB. Choroidal Neovascularization (CNV) Lesion Characteristics\n\nStudy Eye\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 millimeter square \\[mm\\^2\\]) in size at screening\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia\n\nC. Concurrent Ocular Conditions Study Eye\n\n* Retinal pigment epithelial tear\n* Any concurrent intraocular condition\n* Active intraocular inflammation (grade trace or above)\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the randomization visit\n* History of pars plana vitrectomy surgery\n* Aphakia or absence of the posterior capsule\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery\n* Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit\n* Uncontrolled ocular hypertension or glaucoma\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n\nFellow (Non-Study) Eye\n\n• Non-functioning fellow eye\n\nEither Eye\n\n* Any history of uveitis\n* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis","ALL","50 Years",{"count":193,"type":194},68,"ESTIMATED","INTERVENTIONAL",[197],"PHASE3","This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg\u002FmL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.",[200,201],"Neovascular Age-related Macular Degeneration","nAMD","2026-06-04",{"date":204,"type":205},"2026-06-08","ACTUAL",{"date":207,"type":205},"2024-06-17",{"date":209,"type":194},"2029-08-30",{"name":5,"class":6},16]