NCT06585592|Completed
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Sponsor study identifier
observational
500
0 countries
N/A
Study Start
January 1, 2017
Actual (reported)Primary Completion
March 31, 2024
Actual (reported)Study Completion
March 31, 2024
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2017
Actual (reported)March 31, 2024
Actual (reported)March 31, 2024
Actual (reported)August 29, 2024
Actual (reported)September 5, 2024
Actual (reported)Percentage of participants with overall response
Overall response
1 week after the end of treatment
Percentage of participants with overall response
Overall response
24 weeks after the end of treatment
Percentage of participants with overall response
Overall response
52 weeks after the end of treatment
Percentage of participants with overall response
Overall response
104 weeks after the end of treatment
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treament
during the treament
Change of Serum TRAb from baseline
52 weeks after the end of treatment
Change of Serum T3,T4 level from baseline
52 weeks after the end of treatment
Change of Serum lipid parameter
52 weeks after the end of treatment
Change of Serum TSH level from baseline
52 weeks after the end of treatment
Change of extraocular muscle volume and orbital fat volume by MR
52 weeks after the end of treatment
change of extraocular muscle volume and orbital fat volume by MRI
4 weeks after the end of treatment
change of extraocular muscle volume and orbital fat volume by MRI
24 weeks after the end of treatment
Moderate to severe active TAO patients who received complete medical treatment and completed assessment .
Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3.
Li Z, Luo Y, Feng X, Zhang Q, Zhong Q, Weng C, Chen Z, Shen J. Application of Multiparameter Quantitative Magnetic Resonance Imaging in the Evaluation of Graves' Ophthalmopathy. J Magn Reson Imaging. 2023 Oct;58(4):1279-1289. doi: 10.1002/jmri.28642. Epub 2023 Feb 13.
500 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2024
First Posted
September 5, 2024
Study Start
January 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Hu H, Chen L, Zhang JL, Chen W, Chen HH, Liu H, Shi HB, Wu FY, Xu XQ. T2 -Weighted MR Imaging-Derived Radiomics for Pretreatment Determination of Therapeutic Response to Glucocorticoid in Patients With Thyroid-Associated Ophthalmopathy: Comparison With Semiquantitative Evaluation. J Magn Reson Imaging. 2022 Sep;56(3):862-872. doi: 10.1002/jmri.28088. Epub 2022 Jan 29.
Primary Completion
March 31, 2024
Actual (reported)Study Completion
March 31, 2024
Actual (reported)Last Updated
July 1, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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