Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

NCT06590220 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Changzheng Hospital

Phase

Observational

Started

2024-10-09

Last updated

2025-06-24

Condition(s) studied

Thyroid Associated Ophthalmopathy

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Percentage of participants with overall response — 1 week after the end of treatment
Percentage of participants with overall response — 24 weeks after the end of treatment
Percentage of participants with overall response — 52 weeks after the end of treatment
Percentage of participants with overall response — 104 weeks after the end of treatment

Trial sites (1)

Facility	City	Region	Status
Shanghai Changzheng Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06590220 on ClinicalTrials.gov ↗ ← All trials in China