Multi-model Image of Immunosuppressive Agents in TAO

NCT05110040 | Unknown DMC

• 1 other identifier: TAOIMTIMAGE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Associated Ophthalmopathy

Keywords

Thyroid Associated Ophthalmopathy; Immunosuppressive agents; multi-modal image; function assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• change of extraocular muscle volume and orbital fat volume by MRI

  at month 6

• change of proptosis

  at month 6

• change of QoL

  at month 6

• change of eyelid aperture and lid lag

  at month 6

Study Arms (1)

immunosuppressive agents

EXPERIMENTAL

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

Drug: immunosuppressive agent

Interventions

immunosuppressive agent DRUG

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

Also known as: immunosuppressive regulator

immunosuppressive agents

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age 18-70 years old
• Diagnosed with TAO.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Immunosuppressive Agents

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dan Liang

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Liang

CONTACT

（86）-87330402; liangdan@gzzoc.com

Yuxi Chen

CONTACT

（86）-87330402; chenyx293@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Assessors who calculate the changes of the images are masked of the diagnosis and treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan Liang, PhD

Model Details: participants diagnosed of TAO administrated with immunosuppressive agents

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 5, 2021
• Study Start: October 15, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)