Multi-model Image of Immunosuppressive Agents in TAO

NCT ID: NCT05110040

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Thyroid Associated Ophthalmopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

participants diagnosed of TAO administrated with immunosuppressive agents
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Assessors who calculate the changes of the images are masked of the diagnosis and treatment.

Study Groups

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immunosuppressive agents

patients recruited will be treated with one or/and two immnuosuppressive agents

Group Type EXPERIMENTAL

immunosuppressive agent

Intervention Type DRUG

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

Interventions

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immunosuppressive agent

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

Intervention Type DRUG

Other Intervention Names

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immunosuppressive regulator

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Dan Liang

Dan Liang, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Liang

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Liang

Role: CONTACT

(86)-87330402

Yuxi Chen

Role: CONTACT

(86)-87330402

Facility Contacts

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Dan Liang

Role: primary

(86)-87330402

Other Identifiers

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TAOIMTIMAGE

Identifier Type: -

Identifier Source: org_study_id

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