Multi-model Image of Doxycycline in TAO

NCT05112211 | Recruiting DMC

• 1 other identifier: TAODOXYIMAGE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Associated Ophthalmopathy

Keywords

Doxycycline; Thyroid Associated Ophthalmopathy; Extraorbital muscle; Orbit fat volume; Multi-modal image

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change of exophthalmos

  at month 6

• change of Quality of Life

  at month 6

• change of eyelid aperture, lid retraction and lid lag

  at month 6

Study Arms (1)

doxycycline

EXPERIMENTAL

patients administrated with doxycycline tablets 100mg orally per day

Drug: Doxycycline Hyclate

Interventions

Doxycycline Hyclate DRUG

patients administrated with doxycycline tablets 100mg orally per day

doxycycline

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:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Doxycycline

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)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

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: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Patients diagnosed by Thyroid-Associated Ophthalmopahty

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)