Thyroid Associated Ophthalmopathy
Conditions
Brief summary
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO. The aim of this clinical study is to: 1. Found the new diagnostic markers or imaging sequences. 2. Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.
Interventions
None listed
Sponsors
Shanghai Changzheng Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* According to the Bartley criteria，diagnosed TAO at our hospital after 2024/8/31 * Moderate to severe patients defined by EUGOGO * CAS ≥3 (on the 7-item scale) for the study eye
Exclusion criteria
* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision * History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to >1 g of methylprednisolone for the treatment of TAO. * Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study * Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study * Pregnant or lactating * Any other condition that,would impair the ability of the participant to undergo orbital MRI * Incomplete information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with overall response | 1 week after the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) | 1 week after the end of treatment | Safety and Tolerability |
| Change of Serum Lipids parameters from baseline | 104 weeks after the end of treatment | including TG（mmol/L）、TC（mmol/L）、HDL（mmol/L）、LDL（mmol/L） |
| Change of Serum T3、T4 level from baseline | 104 weeks after the end of treatment | including T3（nmol/L）、T4（nmol/L） |
| Change of Serum FT3、FT4 level from baseline | 104 weeks after the end of treatment | including FT3（pmol/L）、FT4（pmol/L） |
| Change of Serum TRAb from baseline | 104 weeks after the end of treatment | including TRAb（IU/l） |
| Change of Serum TSH level from baseline | 104 weeks after the end of treatment | including TSH（mIU/L） |
Other
| Measure | Time frame | Description |
|---|---|---|
| change of extraocular muscle volume and orbital fat volume by MRI | 104 weeks after the end of treatment | — |
| Change of Serum T-cell subgroup | 1 week after the end of treatment | including CD3（%）、CD3 absolute value、CD4（%）、CD4 absolute value、CD8（%）、CD8 absolute value、CD4/CD8（%） |
Countries
China
Contacts
Primary ContactTuo Dr. Li, Vice Professor
Outcome results
None listed