Thyroid Eye Disease
Conditions
Interventions
Observation group of tintuzumab in the treatment of thyroid eye disease:None
Sponsors
Eye and ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older. 2. Meets the diagnostic criteria for TED as defined by the Chinese guideline on the diagnosis and treatment of thyroid- associated ophthalmopathy (2022). 3. The decision to use Teprotumumab has been made by the investigator following communication with the subject. 4. Has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation, or planning to become pregnant within the next six months (applicable to subjects of either sex). 2. Baseline hearing impairment: A history of tinnitus or other hearing impairment in either ear. 3. Poorly controlled diabetes mellitus: Glycated hemoglobin (HbA1c) = 9.0%. 4. Previous use of Rituximab within the past 6 months. 5. Previous use of Tocilizumab within the past 2 months. 6. Known hypersensitivity to Teprotumumab or any excipient in the formulation. 7. Any other reason deemed by the investigator to make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive efficacy;Safety and Tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Activity Score;Exophthalmometry;Ocular Motility;Diplopia Score;Palpebral Fissure Height;Best Corrected Visual Acuity;Orbital Magnetic Resonance Imaging Findings;Incidence of Other Adverse Events;Graves’ Ophthalmopathy Quality of Life; | — |
Countries
China
Contacts
Public ContactJiang Qian
Eye and ENT hospital of Fudan University
Outcome results
None listed