Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Associated Ophthalmopathy

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Tuo Dr. Li, Vice Professor; Phone Number: +86-13918507887; Email: dr.lituo@smmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Recruiting
      • Shanghai Changzheng Hospital
      • Contact: Tuo Dr. Li, Vice Professor; Phone Number: +86-13918507887; Email: zoe_leeto@hotmail.com
      • Contact: Email: young.stone@163.com
      • Principal Investigator: Tuo Li, MD
      • Principal Investigator: Yongquan Shi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe active TAO patients who receive medical treatment and assessment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TAO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)	Safety and Tolerability	1 week after the end of treatment
Change of Serum Lipids parameters from baseline	including TG（mmol/L）、TC（mmol/L）、HDL（mmol/L）、LDL（mmol/L）	104 weeks after the end of treatment
Change of Serum T3、T4 level from baseline	including T3（nmol/L）、T4（nmol/L）	104 weeks after the end of treatment
Change of Serum TSH level from baseline	including TSH（mIU/L）	104 weeks after the end of treatment
Change of Serum FT3、FT4 level from baseline	including FT3（pmol/L）、FT4（pmol/L）	104 weeks after the end of treatment
Change of Serum TRAb from baseline	including TRAb（IU/l）	104 weeks after the end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of extraocular muscle volume and orbital fat volume by MRI		104 weeks after the end of treatment
Change of Serum T-cell subgroup	including CD3（%）、CD3 absolute value、CD4（%）、CD4 absolute value、CD8（%）、CD8 absolute value、CD4/CD8（%）	1 week after the end of treatment
Change of Serum T-cell subgroup	including CD3（%）、CD3 absolute value、CD4（%）、CD4 absolute value、CD8（%）、CD8 absolute value、CD4/CD8（%）	104 weeks after the end of treatment
change of extraocular muscle volume and orbital fat volume by MRI		4 weeks after the end of treatment

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Publications and helpful links

General Publications

• 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.
• Cevik Y, Taylan Sekeroglu H, Ozgen B, Erkan Turan K, Sanac AS. Clinical and Radiological Findings in Patients with Newly Diagnosed Graves' Ophthalmopathy. Int J Endocrinol. 2021 Apr 30;2021:5513008. doi: 10.1155/2021/5513008. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 6, 2028

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 21, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Eye Diseases; Graves Ophthalmopathy
• Other Study ID Numbers: TAO3M-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No