[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637519":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":40,"locations":50,"responsibleParty":64,"collaborators":39,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":39,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":39,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":94,"whyStopped":39,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Postoperative Sequential Teprotumumab N01","EXPERIMENTAL","Participants in this arm will undergo urgent orbital decompression and then receive postoperative sequential Teprotumumab N01.",[13],"Drug: Teprotumumab N01",{"label":15,"type":16,"description":17,"interventionNames":18},"Postoperative Sequential Intravenous Methylprednisolone","ACTIVE_COMPARATOR","Participants in this arm will undergo urgent orbital decompression and then receive postoperative sequential intravenous methylprednisolone.",[19],"Drug: Intravenous Methylprednisolone (IVMP)",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Teprotumumab N01","Teprotumumab N01 will be administered intravenously after urgent orbital decompression. The first infusion will be 10 mg\u002Fkg, followed by 20 mg\u002Fkg every 3 weeks for 7 additional infusions.",[9],[27,28,29],"Teprotumumab","Insulin-like growth factor-1 receptor monoclonal antibody","IGF-1R inhibitor",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Intravenous Methylprednisolone (IVMP)","IVMP will be administered after urgent orbital decompression at 0.5 to 1.0 g per day for 3 consecutive days, followed by oral prednisone tapering according to the participant's clinical status and investigator judgment.",[15],[35,36,37,38],"Methylprednisolone","Methylprednisolone sodium succinate","Intravenous methylprednisolone pulse therapy","IVMP",null,[41,46],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Hui jing Ye, M.D, PhD","CONTACT","+8620-87331539","yehuijing@qq.com",{"name":47,"role":43,"phone":48,"phoneExt":39,"email":49},"Gesang Zhuoma","+86-18008941211","1139148653@qq.com",[51],{"facility":52,"status":39,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":39},"Zhongshan Ophthalmic Center, Sun Yat-sen University","Guangzhou","Guangdong","510000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Huasheng Yang","Clinical Professor","100637519","phase-2-teprotumumab-n01-versus-methylprednisolone-after-urgent-orbital-decompression-for-dysthyroid-optic-neuropathy-100637519",false,"NCT07594912","Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy","A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Study Comparing Sequential Teprotumumab N01 With Intravenous Methylprednisolone After Urgent Orbital Decompression in Patients With Dysthyroid Optic Neuropathy","Inclusion Criteria:\n\n* Able and willing to provide written informed consent.\n* Age 18 to 65 years.\n* Clinical diagnosis of thyroid eye disease (TED) with dysthyroid optic neuropathy (DON). Diagnosis of DON must meet both of the following criteria:\n\n  1. Visual dysfunction not explained by other causes, such as decreased best-corrected visual acuity, visual field defect, abnormal color vision, or relative afferent pupillary defect.\n  2. Imaging evidence of orbital apex crowding, optic nerve compression, or optic nerve stretching.\n* The study eye meets the criteria for urgent orbital decompression, defined as either of the following:\n\n  1. Poor response after rescue intravenous methylprednisolone for the current dysthyroid optic neuropathy episode, with a cumulative methylprednisolone-equivalent dose of no more than 3.0 g, defined as no improvement or continued deterioration of visual function within 1 to 2 weeks.\n  2. Contraindication to glucocorticoids or investigator judgment that direct urgent mechanical decompression is required.\n* Thyroid function is normal or mildly abnormal before enrollment, with free triiodothyronine (FT3) and free thyroxine (FT4) within 50% above or below the normal reference range when possible.\n* Alanine aminotransferase (ALT) no more than 1.5 times the upper limit of normal, aspartate aminotransferase (AST) no more than 3 times the upper limit of normal, and serum creatinine no more than 1.5 times the upper limit of normal.\n* For participants with diabetes mellitus, hemoglobin A1c (HbA1c) less than 9.0% and stable antidiabetic treatment within 60 days before enrollment.\n* For women of childbearing potential, a pregnancy test must be negative before enrollment.\n* Participants of reproductive potential agree to use effective contraception during the study and for 90 days after the last dose of study treatment.\n* Able and willing to comply with study treatment and follow-up procedures.\n\nExclusion Criteria:\n\n* Orbital decompression surgery within 6 months before screening.\n* Bilateral dysthyroid optic neuropathy requiring urgent bilateral orbital decompression at baseline.\n* Cumulative preoperative methylprednisolone-equivalent dose greater than 3.0 g for the current dysthyroid optic neuropathy episode.\n* Systemic glucocorticoid treatment for non-thyroid eye disease within 3 months before screening with cumulative methylprednisolone-equivalent dose of 1.0 g or greater.\n* Tocilizumab or other systemic immunosuppressive treatment within 3 months before screening, or rituximab within 6 months before screening.\n* Orbital radiotherapy within 3 months before screening.\n* Previous treatment with teprotumumab.\n* Other ocular diseases that may significantly affect visual function assessment, including glaucomatous optic neuropathy, macular disease, severe cataract, or non-thyroid eye disease optic neuropathy.\n* Irreversible optic nerve damage in the study eye with very low potential for visual recovery, as judged by the investigator.\n* History of definite inner ear disease or clinically significant hearing impairment.\n* Severe cardiovascular disease.\n* Severe hepatic or renal disease.\n* Active infection or clinically significant infectious disease, including active hepatitis, HIV infection, syphilis, or active tuberculosis.\n* Active gastrointestinal ulcer.\n* Clinically significant abnormal blood test results, including white blood cell count less than 4.0 × 10\\^9\u002FL, platelet count less than 80 × 10\\^9\u002FL, hemoglobin less than 110 g\u002FL in males or less than 100 g\u002FL in females.\n* History of malignancy judged by the investigator to be unsuitable for enrollment.\n* Pregnancy or breastfeeding.\n* Known allergy to monoclonal antibodies, methylprednisolone, or any study drug excipient.\n* Uncontrolled diabetes mellitus or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","ALL","18 Years","65 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","This study aims to evaluate the efficacy and safety of sequential Teprotumumab N01 compared with intravenous methylprednisolone (IVMP) after urgent orbital decompression in patients with dysthyroid optic neuropathy (DON).",[86,87,88],"Thyroid Eye Disease, TED","Graves Ophthalmopathy","Optic Neuropathy",[90,91,23,92,93],"Dysthyroid optic neuropathy","Orbital decompression","Intravenous methylprednisolone pulse","Thyroid eye disease","NOT_YET_RECRUITING","2026-05-17",{"date":97,"type":98},"2026-05-19","ACTUAL",{"date":100,"type":80},"2026-08",{"date":102,"type":80},"2028-04",{"name":5,"class":6},1]