Thyroid eye disease, thyroid associated ophthalmopathy, graves ophthalmopathy
Conditions
Interventions
glucocorticoid:None
anti-IGF-1R monoclonal antibody:None
Anti-il-6r monoclonal antibody:None
Sponsors
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to comply with the study procedures and voluntary signing of the informed consent form; 2. Male or female participants aged between 18 and 75 years (inclusive) at screening; 3. Body weight between 30 kg and 100 kg (inclusive); 4. Meeting the Bartley diagnostic criteria (1995): (1) eyelid retraction; (2) proptosis (exophthalmos); (3) extraocular muscle involvement; (4) optic nerve dysfunction, with or without thyroid dysfunction, and with exclusion of other causes of orbital diseases; 5. Meeting the criteria for the use of glucocorticoids, anti-IGF-1R monoclonal antibody, or anti-IL-6R monoclonal antibody according to the Chinese Guidelines for Diagnosis and Treatment of Thyroid-Associated Ophthalmopathy (2022).
Exclusion criteria
Exclusion criteria: 1. Thyroid function with fT3 or fT4 levels deviating from the normal reference range by more than 50%; 2. Hemoglobin = 1.5× the upper limit of normal, or glomerular filtration rate = the upper limit of normal); 10. Fasting blood glucose (FBG) >= 7.0 mmol/L or glycated hemoglobin (HbA1c) >= 9.0%, or initiation of new antidiabetic medication (oral or injectable) within 2 months prior to screening, or a change in the current prescribed antidiabetic medication dosage of > 10%; 11. Systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg, or adjustment of antihypertensive medication (dose or drug type) within 1 month prior to screening; 12. Presence of uncontrolled disease conditions, including but not limited to asthma, psoriasis, or inflammatory bowel disease that require glucocorticoid therapy at onset; 13. Known allergy to monoclonal antibodies, any excipients, or glucocorticoids; 14. Alcohol, tobacco, drug, or chemical substance abusers (alcohol abuse defined as weekly alcohol intake exceeding 21 units for males or 14 units for females, with 1 unit = 360 mL beer, 150 mL wine, or 45 mL distilled spirits/liquor; tobacco abuse defined as a smoking index [i.e., cigarettes per day × years of smoking] > 400); 15. Female participants who are pregnant or breastfeeding, or male or female participants who plan to become pregnant or have a pregnancy intention during the treatment period or within 3 months after treatment, and who do not agree to use effective contraceptive measures; 16. Other conditions that, in the opinion of the investigator, make the participant unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAS=2; | — |
Countries
China
Contacts
Public ContactJing Sun
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Outcome results
None listed