thyroid-associated ophthalmopathy
Conditions
Interventions
TAO observational cohort:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Willing to follow the study procedures, already clinically decided to receive teprotumumab, and has voluntarily signed informed consent; 2. Male or female aged 18–80 years (inclusive); 3. Meets diagnostic criteria for moderate-to-severe active thyroid-associated ophthalmopathy (TAO) at baseline; 4. Women must be either post-menopausal/post-surgical sterile or have a negative serum pregnancy test at screening, and must use effective contraception from screening until 120 days after the last infusion; men must agree to use contraception during the same period.
Exclusion criteria
Exclusion criteria: 1. Subjects with a previous diagnosis of DON or judged by the investigator to have DON at screening; 2. Subjects with corneal ulcers that show no improvement after treatment, as judged by the investigator; 3. Uncontrolled hyperthyroidism (FT3/FT4 persistently >2× the upper limit of normal); 4. Severe cardiac, hepatic, or renal insufficiency or active malignancy that precludes tolerance to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proptosis response rate (study eye); | — |
Secondary
| Measure | Time frame |
|---|---|
| Graves Ophthalmopathy Quality of Life, GO-QoL;Diploma responder rate; | — |
Countries
China
Contacts
Public ContactHuanbai Xu
Shanghai General Hospital
Outcome results
None listed