Thyroid Eye Disease
Conditions
Interventions
Teprotumumab group:Teprotumumab is administered intravenously at doses of 10 mg/kg and 20 mg/kg every three weeks for a total of 8 infusions. The initial dose is 10 mg/kg, followed by 20 mg/kg for dos
Glucocorticoids group:Methylprednisolone is administered intravenously at a dose of 0.5 g once daily for 3 consecutive days for 2 weeks, followed by 0.5 g once weekly for 4 weeks, and then 0.25 g once
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Comply with the trial protocol and voluntarily sign the informed consent form; 2. Male or female study participants aged between 18 and 75 years (inclusive) at the time of screening; 3. Body weight between 30 and 100 kg (inclusive); 4. Meet internationally recognized diagnostic criteria for Thyroid Eye Disease (TED); 5. Diagnosed with very severe TED and presenting with compressive optic neuropathy during the screening period and at baseline; 6. Clinical course of less than 6 months.
Exclusion criteria
Exclusion criteria: 1. Poorly controlled thyroid function, defined as FT3 or FT4 deviating by more than 50% from the normal reference range. 2. Treatment with radioactive iodine within 3 months prior to screening. 3. Corneal ulceration judged by the investigator as having no relief after treatment. 4. A Clinical Activity Score (CAS) reduction of >=2 points at baseline compared to screening. 5. Previous treatment at any time with monoclonal antibodies such as anti-CD20 antibodies, anti-interleukin-6 antibodies, or anti-IGF-1R antibodies. 6. Previous orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, and eyelid retraction correction) at any time. 7. At any time prior to screening, the cumulative dose of glucocorticoids used for the treatment of TED >=1 g of methylprednisolone equivalent; oral or intravenous glucocorticoids within 30 days prior to screening; periocular/orbital injection of glucocorticoids within 90 days prior to screening; use of glucocorticoid ophthalmic solutions/ointments or non-steroidal immunosuppressive ophthalmic solutions within 30 days prior to screening. 8. Treatment with any other oral or intravenous immunosuppressants within 3 months prior to screening. 9. Vaccination within 1 month prior to screening. 10. Hemoglobin upper limit of normal [ULN] or undergoing anti-HBV therapy), hepatitis C (HCV antibody or HCV RNA positive), syphilis, herpes, herpes zoster, etc. 12. History of gastrointestinal ulcer or diverticulitis, Cushing's disease, osteoporosis, or psychiatric disorders. 13. History of immunodeficiency, including HIV infection or AIDS, other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 14. History of autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, etc. 15. History or current presence of malignancy (except successfully resected squamous cell carcinoma, basal cell carcinoma of the skin, or localized carcinoma in situ of the cervix with no evidence of metastasis). 16. History of severe cardiovascular and cerebrovascular diseases and their treatments, including but not limited to cerebrovascular accident, transient ischemic attack, acute myocardial infarction, unstable angina, arrhythmia, cardiac insufficiency, coronary artery bypass graft, percutaneous coronary intervention, etc. 17. Severe hepatic or renal insufficiency (liver disease or abnormal liver function, ALT or AST >=1.5 × ULN; glomerular filtration rate = ULN). 18. Poorly controlled diabetes, defined as fasting blood glucose>=7.0 mmol/L or glycated hemoglobin (HbA1c) >=9.0% at screening, OR initiation of new diabetes medication (oral or injectable) within 2 months prior to screening OR a change >10% in the dose of currently prescribed diabetes medication. 19. Poorly controlled hypertension, defined as systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg, OR adjustment of antihypertensive medication (dose or type) within 1 month prior to screening. 20. Presence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity, BCVA;Mean Deviation of Visual Field Test ;Color Vision Deficit;Optic Disc Edema;Clinical activity score, CAS;Proptosis;Height of palpebral fissure, MRD;Intraocular pressure, IOP;Diplopia;Ocular movement;GO-QoL;Surgical Avoidance Rate;MRI measurement;Visual evoked potential, VEP; | — |
Countries
China
Contacts
Public ContactJing Sun
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed