Thyroid Eye Disease
Conditions
Interventions
The Teprotumumab group:None
The non-Teprotumumab group:None
Sponsors
The First Hospital to China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: (1) Thyroid eye disease was diagnosed (referring to the Bartley criteria and the Chinese guidelines), and at the time of enrollment, at least one treatment method for thyroid eye disease (including glucocorticoids, immunosuppressants, biologics, orbital surgery, and orbital radiotherapy) was initiated, including the first or multiple starts of treatment. Or subjects who are currently receiving at least one of the above-mentioned treatment methods for thyroid eye disease and have relevant data of physical examination and examination for thyroid eye disease before treatment 2: (2) Comply with the trial procedures and voluntarily sign the informed consent form 3: (3) Age and gender: Male or female subjects aged between 18 and 80 years (inclusive) at the time of screening 4: (4) If the subject is a female, she should be a fertile woman who is infertile or has a negative blood pregnancy test result during the screening period and has agreed to take contraceptive measures from the screening period to 120 days after the last treatment. If the subject is male, they should agree to take contraceptive measures from the screening period to 120 days after the last treatment.
Exclusion criteria
Exclusion criteria: 1: (1) For the subjects who were undergoing treatment for thyroid ophthalmopathy (including glucocorticoids, immunosuppressants, biological agents, orbital surgery, and orbital radiotherapy) at the time of enrollment, there were no relevant physical examinations and related data for thyroid ophthalmopathy before treatment 2: (2) Have participated in other interventional clinical trials within 90 days before screening (if it is a drug, within its 5 half-lives, whichever is longer) 3: Except for vitamins and minerals, or attempting to participate in other clinical trials during the research period 4: (3) Any disease with an expected lifespan of less than 2 years 5: (4) Pregnant or lactating women 6: (5) Those whose researchers consider themselves unsuitable to participate in this clinical trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exophthalmos;CVA (corrected visual acuity);Height of palpebral fissure;IOP(intraocular pressure);CAS score;grade;Eye movement restriction;2-hour post-meal blood glucose;Thyroid Eye Disease Quality of Life Questionnaire;Rate of exophthalmos response;The percentage of subjects with a CAS value of 0 or 1;The change in the degree of eye protrusion compared to the baseline;Ocular diplopia response rate;Visual function score;Appearance score;Recurrent rate of thyroid eye disease;Delay in Treating Thyroid Eye Disease in China;The delay in treatment for TED = Time of diagnosis of TED - Time of onset of eye-related symptoms. Screening rate for thyroid eye disease in China; | — |
Secondary
| Measure | Time frame |
|---|---|
| free triiodothyronine;free thyroxine;hormothyrin;thyrotropin receptor antibody;thyroid peroxidase antibody;thyroglobulin antibodies;Total triiodothyronine;Total Thyroxine;Triiodothyronine antagonist;thyroid stimulating immunoglobulin;thyroid ultrasound;Fundus optical coherence tomography;Fundus scanning laser fundus camera;Optic nerve assessment;Ophthalmic ultrasound;Orbital CT;Ophthalmic color ultrasound;Orbital MRI enhancement;Orbital radionuclide imaging; | — |
Countries
China
Contacts
Public ContactShan Zhongyan
The First Hospital to China Medical University
Outcome results
None listed