Multi-model Image of Immunosuppressive Agents in TAO

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

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Associated Ophthalmopathy
• Intervention / Treatment: Drug: immunosuppressive agent

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immunosuppressive agents; patients recruited will be treated with one or／and two immnuosuppressive agents	Drug: immunosuppressive agent; patients with TAO recruited in this study will administrated with immunosuppressive agent per day; Other Names: immunosuppressive regulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change of proptosis	proptosis will be measured by the same investigator using the same Hertel instrument	at month 6
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
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Immunosuppressive agents; Thyroid Associated Ophthalmopathy; multi-modal image; function assessment
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: TAOIMTIMAGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No