Thyroid Eye Disease
Conditions
Interventions
Group 1:None
Group 2:None
Group 3:None
Sponsors
Nanjing First Hospital, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with Thyroid Eye Disease (according to Bartley criteria and Chinese guidelines), and at enrollment is initiating (for the first time or repeatedly) or is currently receiving at least one TED treatment (including glucocorticoids, immunosuppressants, biologics, orbital surgery, or orbital radiotherapy), with available pre-treatment physical examination and investigational data related to TED. (2) Willing to comply with the trial procedures and voluntarily provide signed informed consent. (3) Male or female subjects aged 18 to 80 years (inclusive) at screening. (4) Female subjects must be either of non-childbearing potential, or of childbearing potential with a negative pregnancy test during screening and agreement to use contraception from screening until 120 days after the last treatment; male subjects must agree to use contraception from screening until 120 days after the last treatment.
Exclusion criteria
Exclusion criteria: (1) Subjects undergoing active Thyroid Eye Disease treatment (including glucocorticoids, immunosuppressants, biologics, orbital surgery, or orbital radiotherapy) at enrollment, without available pre-treatment ophthalmic examination and investigational data related to TED; (2) Participation in any interventional clinical trial within 90 days prior to screening (or within 5 half-lives for investigational drugs, whichever is longer; excluding vitamins and minerals), or planned participation in another clinical trial during the study period; (3) Any medical condition with a life expectancy of less than 2 years; (4) Pregnant or breastfeeding women; (5) Subjects considered by the investigator to be unsuitable for this clinical trial for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity;Proptosis;CAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Auditory Function;Quality of Life Scale Score; | — |
Countries
China
Contacts
Public ContactLi Qian
Nanjing First Hospital, Nanjing Medical University
Outcome results
None listed