Multi-model Image of Immunosuppressive Agents in TAO

Thyroid Associated Ophthalmopathy Clinical Trial

Official title:

A Multi-model Image of Immunosuppressive Agents in Thyroid Associated Ophthalmopathy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110040
• Other study ID #: TAOIMTIMAGE
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Dan Liang
• Phone: (86)-87330402
• Email: liangdan[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model image.

Description:

Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. A great number of patients in inactive phase becoming refractory and reoccurring.

Until now, the improvement of TAO is still be measured subjectively with low reliability and less accuracy. Multi-modal image is a new method to assess both the appearance and visual function of TAO and some of the indexes can be regarded as more apparent and stable in assessing the efficacy and prognosis of TAO.

This perspective cohort study aims to evaluate the efficacy of immunosuppressive agents in TAO by multi-model image and function assessments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Age 18-70 years old

• Diagnosed with TAO.

Exclusion Criteria:

• Contraindications to immunosuppressive agents.

• Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection.

• Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents.

• Patients have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination).

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathy
• Thyroid Diseases

Intervention

Drug:
• immunosuppressive agent
patients with TAO recruited in this study will administrated with immunosuppressive agent per day

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of macular sensibility	the same investigator uses the same instrument to assess the macular sensibility. The better change of macular sensibility means the better outcome.	At 6 months
Secondary	change of extraocular muscle volume and orbital fat volume by MRI	A 3D MRI reconstructive model will be established and the volume of extraocular muscle and orbital fat will be calculated by the same advanced programmer who is blinded of the pre- or post- treatment images order. The higher the value changes, the better the outcome is.	at month 6
Secondary	change of proptosis	proptosis will be measured by the same investigator using the same Hertel instrument	at month 6
Secondary	change of QoL	the score of quality of life will be assessed by the same investigator using GO-QoL. The higher change of quality of life means the better outcome.	at month 6
Secondary	change of eyelid aperture and lid lag	the values will be measured by the same investigator using the same millimeter ruler and the higher change of eyelid aperture and lid lag means the better outcome	at month 6