Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

Not yet recruiting

• Conditions: Thyroid Associated Ophthalmopathy

• Registration Number: NCT06590220
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study Start: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Primary Completion: 2026-09-06
• Study Completion: 2028-09-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants with overall response	104 weeks after the end of treatment

Secondary Outcome Measures

Name	Time	Method
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 TSH level from baseline	104 weeks after the end of treatment	including TSH（mIU/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）