thyroid eye disease
Conditions
Interventions
Control group:Treatment with methylprednisolone therapy alone.
Experimental group:Treatment with teprotumumab combined with methylprednisolone therapy.
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet diagnostic criteria for active dysthyroid optic neuropathy; 2.Male or female aged between 18 and 70 years; 3. Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Use of methylprednisolone pulse therapy with a cumulative dose of =2 g within the past 4 weeks, or treatment with tocilizumab or rituximab; 2.Concomitant conditions that may significantly affect visual function, including congenital/toxic/ischemic/inflammatory optic neuritis, cataract, glaucoma, maculopathy, high myopia, high astigmatism, and congenital dyschromatopsia; 3.Conditions requiring emergency surgical intervention, such as severe corneal ulcer, perforation or abscess; 4.Severe acute or chronic infections, including but not limited to systemic infections such as sepsis, positive HIV antibody or HCV antibody or active syphilis; 5.Hepatitis B not controlled by medication; 6. Active pulmonary tuberculosis or tuberculosis not controlled by medication; 7.Severe osteoporosis not effectively controlled by treatment; 8. Uncontrolled diabetes mellitus: fasting blood glucose >11.1 mmol/L despite pharmacological management; 9.Uncontrolled hypertension: systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg despite pharmacological management, or secondary hypertension such as renal artery stenosis, Cushing's syndrome, primary aldosteronism, or pheochromocytoma; 10.Active peptic ulcer or gastrointestinal bleeding; 11.Psychiatric disorders; 12.Hearing impairment, including tinnitus or hearing loss; 13.History of inflammatory bowel disease; 14.Malignant tumors that are untreated or not effectively controlled; 15. Severe dysfuntion of vital organs such as the heart, lungs, liver, or kidneys; 16.Pregnancy or breastfeeding, or women of childbearing potential who are unable or unwilling to use adequate contraception. 17.Allergy to methylprednisolone or its components, or to teprotumumab and its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of eyes with a Clinical Activity Score (CAS) of 0 or 1;Changes in CAS;Changes in BCVA of the affected eye;Changes in proptosis;adverse event and severe adverse event;Changes in radiographic orbital apex crowding of the affected eye;Changes in GO-QoL score;Proportion of patients with proptosis improvement =2 mm;;Changes in visual field MD of the affected eye; | — |
Countries
China
Contacts
Public ContactHong Shubin
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed