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Completed

NCT Number: NCT06585592

Establishment of Multimodal-multiparametric Progressive Prediction Models for 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 characteristic changes from baseline to the end of treatment. 2. Identify characteristic changes associated with treatment response. 3. Construct a multimodal and multiparameter prediction model by characteristic changes.

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Key information

Conditions

Thyroid-Associated Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • According to the Bartley criteria，diagnosed TAO from 2017/1/1 to 2024/3/31
  • Moderate to severe patients defined by EUGOGO
  • CAS ≥4 (on the 7-item scale) for the study eye
  • Completed orbital MRI at our hospital
  • Received complete medical treatment and completed assessment at our hospital

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 investigators 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 participants participation in the study
  • Pregnant or lactating
  • Any other condition that,would impair the ability of the participant to undergo orbital MRI

Treatment and study plan

Primary outcomes

  1. Percentage of participants with overall response

    Time frame: 1 week after the end of treatment

    Overall response

  2. Percentage of participants with overall response

    Time frame: 24 weeks after the end of treatment

    Overall response

  3. Percentage of participants with overall response

    Time frame: 52 weeks after the end of treatment

    Overall response

  4. Percentage of participants with overall response

    Time frame: 104 weeks after the end of treatment

    Overall response

Secondary outcomes

  1. Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treament

    Time frame: during the treament

  2. Change of Serum TRAb from baseline

    Time frame: 52 weeks after the end of treatment

    including TRAb (IU/l)

  3. Change of Serum T3,T4 level from baseline

    Time frame: 52 weeks after the end of treatment

    inculde T3 (nmol/L), T4 (nmol/L)

  4. Change of Serum lipid parameter

    Time frame: 52 weeks after the end of treatment

    including TG (mmol/L), TC (mmol/L), HDL (mmol/L), LDL (mmol/L)

  5. Change of Serum TSH level from baseline

    Time frame: 52 weeks after the end of treatment

    including TSH (mIU/L)

  6. Change of Serum FT3, FT4 level from baseline

    Time frame: 104 weeks after the end of treatment

    including FT3 (pmol/L), FT4(pmol/L)

Other outcomes

  1. Change of extraocular muscle volume and orbital fat volume by MR

    Time frame: 52 weeks after the end of treatment

  2. change of extraocular muscle volume and orbital fat volume by MRI

    Time frame: 4 weeks after the end of treatment

  3. change of extraocular muscle volume and orbital fat volume by MRI

    Time frame: 24 weeks after the end of treatment

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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