Thyroid Associated OphthalmopathyPhase 3NCT04548284
Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO
A Phase 3 study testing Glucocorticoids in people with Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- Glucocorticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- May 2021to Dec 2023
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General conditions:
- clinically diagnosed as thyroid disease;
- able and willing to participate in clinical trials and ensure regular follow-up.
- Eye condition:
- patients with monocular disease diagnosed by TAO;
- EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
- the course of eye disease was less than 12mo and had not been treated in the past.
Who cannot join
- General situation:
- patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
- blood pressure still fluctuated > 180/110mmHg after medication;
- obvious liver and kidney insufficiency;
- contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
- patients with severe abnormal blood coagulation;
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- patients with other systemic immune diseases;
- any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
- history of chronic infection;
- pregnant and lactating women.
- Eye conditions:
- B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
- moderate to severe TAO, in either eye requiring local or systemic treatment;
- periorbital infectious diseases, hemorrhagic diseases;
- uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.
- those who studied the eyes who had a history of arbitrary surgery;
- those who were considered by the researchers to be excluded.
Trial locations and contacts
1 site in 1 country.
Huasheng Yang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Huasheng Yang, M.D, PHD, +8620-87331539, yanghs64@126.com
About this study
Official title: Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study
The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- Glucocorticoids
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Periorbital injection of glucocorticoid. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Periorbitally Injected Glucocorticoids | Experimental | Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up. Receives: Drug: Glucocorticoids |
| Observe | No intervention | Observe and wait. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Clinical Activity Score (CAS) score
Comparison of CAS scores before and after treatment in each arm and an inter-arm. The range of CAS scores is 0-7, with 3 as the boundary. The higher the score, the higher the activity.
Measured: baseline、3months、6months、9months、12months
Change of NOSPECS score
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. The NOSPECS score was 0-6. The higher the score, the higher the severity.
Measured: baseline、3months、6months、9months、12months
Secondary outcomes (2)
adverse events
Comparison of adverse events rate in each arm and an inter-arm.
Measured: baseline、3months、6months、9months、12months
Quality of life questionnaires (GO-QoL)
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm. The GO-QOL score is between 0 and 100. The higher the score, the better the quality of life.
Measured: baseline、3months、6months、9months、12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startMay 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
- Investigators
- Huasheng Yang, Doctor, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548284
- Sponsor's protocol ID
- yanghs202009
- Status last verified
- May 2021
- First submitted
- 7 Sep 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04548284
- Acronym / sponsor ID
- yanghs202009
- Conditions
- Thyroid Associated Ophthalmopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Sep 2020 (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.
The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periorbitally Injected Glucocorticoids | Experimental | Drug: GlucocorticoidsGlucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up. |
| Observe | No intervention | –Observe and wait. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinically diagnosed as thyroid disease;
- able and willing to participate in clinical trials and ensure regular follow-up.
- patients with monocular disease diagnosed by TAO;
- EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
- the course of eye disease was less than 12mo and had not been treated in the past.
Key exclusion criteria (17 listed)
- patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
- blood pressure still fluctuated > 180/110mmHg after medication;
- obvious liver and kidney insufficiency;
- contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
- patients with severe abnormal blood coagulation;
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 |
|---|---|---|
| GlucocorticoidsPeriorbital injection of glucocorticoid. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up. | Drug | Periorbitally Injected Glucocorticoids |
Primary outcome
Change of Clinical Activity Score (CAS) score
Time frame: baseline、3months、6months、9months、12months
Comparison of CAS scores before and after treatment in each arm and an inter-arm. The range of CAS scores is 0-7, with 3 as the boundary. The higher the score, the higher the activity.
Change of NOSPECS score
Time frame: baseline、3months、6months、9months、12months
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. The NOSPECS score was 0-6. The higher the score, the higher the severity.
2 secondary outcomes
adverse events
Time frame: baseline、3months、6months、9months、12months
Quality of life questionnaires (GO-QoL)
Time frame: baseline、3months、6months、9months、12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Huasheng Yang, Doctor contact
Huasheng Yang, Doctor study chair
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 Phase 3 study testing Glucocorticoids 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 7 inclusion and 17 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 May 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huasheng Yang, M.D, PHD (+8620-87331539, yanghs64@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clinical Activity Score (CAS) score (time frame: baseline、3months、6months、9months、12months). The study lists 2 primary outcomes in all. 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 May 2021.