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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05110040
Other study ID # TAOIMTIMAGE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT05276063 - A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
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Active, not recruiting NCT06269393 - A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy Phase 3
Not yet recruiting NCT03098225 - A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy Phase 4
Recruiting NCT05112211 - Multi-model Image of Doxycycline in TAO N/A