Multi-model Image of Doxycycline in TAO

A Multi-model Image to Evaluate the Efficacy of Doxycycline in Thyroid Associated Ophthalmopathy

This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal image.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Associated Ophthalmopathy
• Intervention / Treatment: Drug: Doxycycline Hyclate

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. Different degrees of exophthalmos, eyelid aperture, lid retraction and lid lag are common symptoms apprearing in TAO. The improvement of exophthalmos is usually measured with Hertel instrument and the change of eyelid is measured with millimeter ruler. All these measurements are subjective, low reliable and less accurate.

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. But still a progression and reoccurrence can be a big challenge for ophthalmologists. This is a perspective cohort study to evaluate the efficacy of doxycycline in TAO by multi-model image.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Liang; Phone Number: （86）-87330402; Email: liangdan@gzzoc.com
• Study Contact Backup: Name: Yuxi Chen; Phone Number: （86）-87330402; Email: chenyx293@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: Dan Liang; Phone Number: （86）-87330402; Email: liangdan@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Sight-threatening TAO with dysthyroid optic neuropathy
• Allergy of tetracycline
• 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: Screening
• 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: doxycycline; patients administrated with doxycycline tablets 100mg orally per day	Drug: Doxycycline Hyclate; patients administrated with doxycycline tablets 100mg orally per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of extraocular muscle volume and orbital fat volume by MRI	3D MRI image 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. A higher score means a better outcome.	at month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of exophthalmos	exophthalmos will be measured by the same investigator using the same Hertel instrument. A higher change of exphthalmos means a better outcome.	at month 6
change of Quality of Life	The score of quality of life will be assessed by the same investigator using GO-QoL. The better change of quality of life means a better outcome.	at month 6
change of eyelid aperture, lid retraction and lid lag	the values will be measured by the same investigator using the same millimeter ruler and the higher values change, the better the outcome is.	at month 6

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Dan Liang, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Doxycycline; Thyroid Associated Ophthalmopathy; Extraorbital muscle; Orbit fat volume; Multi-modal image
• 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; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: TAODOXYIMAGE

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