Thyroid Associated OphthalmopathyNCT05112211
Multi-model Image of Doxycycline in TAO
A study testing Doxycycline Hyclate in people with Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal image. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- Doxycycline Hyclate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age 18-70 years old
- Diagnosed with TAO
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong
Dan Liang, （86）-87330402, liangdan@gzzoc.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- Doxycycline Hyclate
- Keywords
- Doxycycline, Thyroid Associated Ophthalmopathy, Extraorbital muscle, Orbit fat volume, Multi-modal image
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline HyclateDrug
patients administrated with doxycycline tablets 100mg orally per day
| Study group | Role | What they receive |
|---|---|---|
| doxycycline | Experimental | patients administrated with doxycycline tablets 100mg orally per day Receives: Drug: Doxycycline Hyclate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at month 6
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jan 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Associated OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients diagnosed by Thyroid-Associated Ophthalmopahty
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan Liang, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112211
- Sponsor's protocol ID
- TAODOXYIMAGE
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-model Image to Evaluate the Efficacy of Doxycycline in Thyroid Associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT05112211
- Acronym / sponsor ID
- TAODOXYIMAGE
- Conditions
- Thyroid Associated Ophthalmopathy
- Keywords
- Doxycycline, Thyroid Associated Ophthalmopathy, Extraorbital muscle, Orbit fat volume, Multi-modal image
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal image.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients diagnosed by Thyroid-Associated Ophthalmopahty
| Arm | Type | Receives |
|---|---|---|
| doxycycline | Experimental | Drug: Doxycycline Hyclatepatients administrated with doxycycline tablets 100mg orally per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Age 18-70 years old
- Diagnosed with TAO
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline Hyclatepatients administrated with doxycycline tablets 100mg orally per day | Drug | doxycycline |
Primary outcome
change of extraocular muscle volume and orbital fat volume by MRI
Time frame: at month 6
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.
3 secondary outcomes
change of exophthalmos
Time frame: at month 6
change of Quality of Life
Time frame: at month 6
change of eyelid aperture, lid retraction and lid lag
Time frame: at month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Liang principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline Hyclate in people with Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Liang (（86）-87330402, liangdan@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of extraocular muscle volume and orbital fat volume by MRI (time frame: at month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.