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NCT Number: NCT06590220

Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location status: Recruiting

Location contact

Tuo Dr. Li, Vice Professor

CONTACT

[email protected]

+86-13918507887

Tuo Li, MD

PRINCIPAL_INVESTIGATOR

Yongquan Shi, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Percentage of participants with overall response

    Time frame: 1 week after the end of treatment

  2. Percentage of participants with overall response

    Time frame: 24 weeks after the end of treatment

  3. Percentage of participants with overall response

    Time frame: 52 weeks after the end of treatment

  4. Percentage of participants with overall response

    Time frame: 104 weeks after the end of treatment

Secondary outcomes

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

    Time frame: 1 week after the end of treatment

    Safety and Tolerability

  2. Change of Serum Lipids parameters from baseline

    Time frame: 104 weeks after the end of treatment

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

  3. Change of Serum T3、T4 level from baseline

    Time frame: 104 weeks after the end of treatment

    including T3(nmol/L)、T4(nmol/L)

  4. Change of Serum TSH level from baseline

    Time frame: 104 weeks after the end of treatment

    including TSH(mIU/L)

  5. Change of Serum FT3、FT4 level from baseline

    Time frame: 104 weeks after the end of treatment

    including FT3(pmol/L)、FT4(pmol/L)

  6. Change of Serum TRAb from baseline

    Time frame: 104 weeks after the end of treatment

    including TRAb(IU/l)

Other outcomes

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

    Time frame: 104 weeks after the end of treatment

  2. Change of Serum T-cell subgroup

    Time frame: 1 week after the end of treatment

    including CD3(%)、CD3 absolute value、CD4(%)、CD4 absolute value、CD8(%)、CD8 absolute value、CD4/CD8(%)

  3. Change of Serum T-cell subgroup

    Time frame: 104 weeks after the end of treatment

    including CD3(%)、CD3 absolute value、CD4(%)、CD4 absolute value、CD8(%)、CD8 absolute value、CD4/CD8(%)

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

    Time frame: 4 weeks after the end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Tuo Dr. Li, Vice Professor

CONTACT

[email protected]

+86-13918507887

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Jun 24, 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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