Thyroid Associated OphthalmopathyNCT05110040
Multi-model Image of Immunosuppressive Agents in TAO
A study testing immunosuppressive agent 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 immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model 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?
- immunosuppressive agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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).
Trial locations and contacts
1 site in 1 country.
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 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.
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. 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.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- immunosuppressive agent
- Keywords
- Thyroid Associated Ophthalmopathy, Immunosuppressive agents, multi-modal image, function assessment
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunosuppressive agentDrug
Also called immunosuppressive regulator
patients with TAO recruited in this study will administrated with immunosuppressive agent per day
| Study group | Role | What they receive |
|---|---|---|
| immunosuppressive agents | Experimental | patients recruited will be treated with one or／and two immnuosuppressive agents Receives: Drug: immunosuppressive agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (4)
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.
Measured: at month 6
change of proptosis
proptosis will be measured by the same investigator using the same Hertel instrument
Measured: 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.
Measured: 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
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 posted5 Nov 2021
- Study start15 Oct 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- participants diagnosed of TAO administrated with immunosuppressive agents
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT05110040
- Sponsor's protocol ID
- TAOIMTIMAGE
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2021
- Last updated
- 18 Apr 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-model Image of Immunosuppressive Agents in Thyroid Associated Ophthalmopathy.
- ClinicalTrials.gov ID
- NCT05110040
- Acronym / sponsor ID
- TAOIMTIMAGE
- Conditions
- Thyroid Associated Ophthalmopathy
- Keywords
- Thyroid Associated Ophthalmopathy, Immunosuppressive agents, multi-modal image, function assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 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 immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model 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. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- participants diagnosed of TAO administrated with immunosuppressive agents
| Arm | Type | Receives |
|---|---|---|
| immunosuppressive agents | Experimental | Drug: immunosuppressive agentpatients recruited will be treated with one or／and two immnuosuppressive agents |
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 (4 listed)
- 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).
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 |
|---|---|---|
| immunosuppressive agentAlso: immunosuppressive regulatorpatients with TAO recruited in this study will administrated with immunosuppressive agent per day | Drug | immunosuppressive agents |
Primary outcome
change of macular sensibility
Time frame: At 6 months
the same investigator uses the same instrument to assess the macular sensibility. The better change of macular sensibility means the better outcome.
4 secondary outcomes
change of extraocular muscle volume and orbital fat volume by MRI
Time frame: at month 6
change of proptosis
Time frame: at month 6
change of QoL
Time frame: at month 6
change of eyelid aperture and lid lag
Time frame: at month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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. This study is not recruiting at the moment.
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 immunosuppressive agent 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 4 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: status not confirmed, as of the sponsor's last update on 18 Apr 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?
Results are not available in the source record.
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 macular sensibility (time frame: At 6 months). 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 18 Apr 2023.