Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06590220

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

Led by Shanghai Changzheng Hospital · Updated on 2025-06-24

150

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Thyroid-associated ophthalmopathy (TAO) is an autoimmune disease linked to thyroid problems, commonly causing orbital disease in adults and often associated with Graves disease. The symptoms of TAO vary widely, and in severe cases, it can seriously harm vision and daily life, potentially causing corneal damage and blindness. Researchers are aiming to find new diagnostic markers or imaging techniques and to create a detailed prediction model for moderate to severe TAO to improve diagnosis and management. This observational study will monitor participants diagnosed with moderate to severe TAO according to established criteria. The study focuses on collecting clinical information and imaging data to develop and validate a multiparametric prediction model. There are no drug or treatment interventions; instead, participants will undergo assessments and imaging relevant to their condition as part of the study process. Participants will be evaluated at various times, including assessments of overall response at 1, 24, 52, and 104 weeks after the end of treatment. Researchers will also monitor changes in blood markers related to thyroid function and lipid levels over 104 weeks. Safety will be assessed by recording any non-serious adverse events shortly after treatment. The total participation duration covers over two years, with regular follow-ups and data collection to understand TAO progression and treatment outcomes.

CONDITIONS

Brief Title

Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with thyroid-associated ophthalmopathy according to Bartley criteria after August 31, 2024
  • Moderate to severe TAO as defined by EUGOGO
  • Clinical activity score (CAS) of 3 or higher on the 7-item scale for the study eye
Not Eligible

You will not qualify if you...

  • Need for urgent intervention due to sight-threatening complications or acute vision worsening
  • History of systemic steroid use over 1 gram methylprednisolone equivalent for TAO
  • Any major illness or unstable condition that increases risk or affects safety assessments
  • Any condition impairing ability to comply with study procedures or interpret study data
  • Pregnant or lactating women
  • Any condition preventing orbital MRI
  • Incomplete medical information

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 104 weeks

Participants with moderate to severe thyroid-associated ophthalmopathy are observed to collect clinical and laboratory measurements over time.

Periodic visits over 2 years

Trial Site Locations

Total: 1 location

1

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China, 200003

Actively Recruiting

Loading map...

Research Team

T

Tuo Dr. Li, Vice Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Construction and Application of Precise Diagnosis and Treatm...

Thyroid Associated Ophthalmopathy

Actively Recruiting

1 location

Extension Study to Evaluate Two Doses of Linsitinib in Adult...

Thyroid Eye Disease

Actively Recruiting

2 locations

A Multi-model Image to Evaluate the Efficacy of Doxycycline ...

Thyroid Associated Ophthalmopathy

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL.

Linhan Zhai, Ban Luo, Hongyu Wu...

https://pubmed.ncbi.nlm.nih.gov/34252869