Thyroid Associated OphthalmopathyPhase 4NCT03107078
Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
A Phase 4 study testing Glucocorticoids in people with Thyroid Associated Ophthalmopathy, run by Jie Shen at 1 site in China.
Trial summary
For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. 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
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 1 Oct 2021
- Phase
- Phase 4
- 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
- The diagnostic standard of TAO is according to Bartley's criteria.
- Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
- CAS≥3/7.
- None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.
Who cannot join
- NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
- Suffering from other eye diseases or wearing contact lenses.
- Suffering from other autoimmune diseases.
- Acute and chronic infectious diseases.
- Diabetic retinopathy or hypertensive fundus lesions.
- Patients received orbital decompression or other orbital surgery.
- Suffering from eye trauma or ocular surface disease.
- Special occupants, and the working environment has obvious air pollution etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
zhang qun, 020-62784060, Zq1979@smu.edu.cn
Shen Jie
About this study
Official title: Using A Novel Classification System in Intravenous Glucocorticoids Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.
Read the detailed description
TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.
- 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
Also called Methylprednisolone
Intravenous Glucocorticoids (GCs)
| Study group | Role | What they receive |
|---|---|---|
| Group Ia | Experimental | I:The increase of fat volume dominates .
a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks. Receives: Drug: Glucocorticoids |
| Group Ib | Experimental | I:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months. Receives: Drug: Glucocorticoids |
| Group IIa | Experimental | II:The increase of extraocular muscles volume dominates .
a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks. Receives: Drug: Glucocorticoids |
| Group IIb | Experimental | II:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months. Receives: Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
"Response" was defined as at least three of the following outcome measures:
- reduction in lid width by at least 3 mm;
- reduction in any of the class 2 NOSPECS signs by at least two grades;
- reduction in proptosis by at least 2 mm;
- reduction in intraocular pressure by at least 2 mm Hg;
- improvement in CAS by at least two points;
- improvement in diplopia (disappearance or degrade in degree);
- improvement in visual acuity by 1 Snellen line.
Measured: 2years
Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
"Deterioration" of each parameter was defined as follows:
- increase in lid width by at least 3 mm;
- increase in any of the class 2 NOSPECS signs by at least two grades;
- increase in proptosis by at least 2 mm;
- increase in intraocular pressure by at least 2 mm Hg;
- increase in CAS by at least two points;
- increase in diplopia (new onset or upgrade in degree);
- decrease in visual acuity by 1 Snellen line.
Measured: 2years
Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
"Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Oct 2016
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Associated OphthalmopathyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Shen
- Sponsor type
- Other government
- Collaborators
- The Fifth Affiliated Hospital of Southern Medical University, Huadu District People's Hospital of Guangzhou, Zhujiang Hospital
- Responsible party
- Sponsor-investigator, Jie Shen, The Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107078
- Sponsor's protocol ID
- ThirdAffiliatedHospitalOfSMU
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Luo Y, Huang Q, Chen Z, Song D, Pan D, Hu S, Jiang W, Cai Q, Feng X, Zhang Q, Weng C, Zhong Q, Zhao T, Li C, Zhang T, Shen J. A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy. J Clin Endocrinol Metab. 2023 Dec 21;109(1):36-45. doi: 10.1210/clinem/dgad476.
PubMed 37579198
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using A Novel Classification System in Intravenous Glucocorticoids Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
- ClinicalTrials.gov ID
- NCT03107078
- Acronym / sponsor ID
- ThirdAffiliatedHospitalOfSMU
- Conditions
- Thyroid Associated Ophthalmopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jie ShenOther government
- Collaborators
- The Fifth Affiliated Hospital of Southern Medical University, Huadu District People's Hospital of Guangzhou, Zhujiang Hospital
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 11 Apr 2017 (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.
For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.
Detailed description
TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Ia | Experimental | Drug: GlucocorticoidsI:The increase of fat volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks. |
| Group Ib | Experimental | Drug: GlucocorticoidsI:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months. |
| Group IIa | Experimental | Drug: GlucocorticoidsII:The increase of extraocular muscles volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks. |
| Group IIb | Experimental | Drug: GlucocorticoidsII:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnostic standard of TAO is according to Bartley's criteria.
- Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
- CAS≥3/7.
- None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.
Key exclusion criteria (8 listed)
- NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
- Suffering from other eye diseases or wearing contact lenses.
- Suffering from other autoimmune diseases.
- Acute and chronic infectious diseases.
- Diabetic retinopathy or hypertensive fundus lesions.
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 |
|---|---|---|
| GlucocorticoidsAlso: MethylprednisoloneIntravenous Glucocorticoids (GCs) | Drug | Group IIa, Group IIb, Group Ia, Group Ib |
Primary outcome
Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
Time frame: 2years
"Response" was defined as at least three of the following outcome measures: 1. reduction in lid width by at least 3 mm; 2. reduction in any of the class 2 NOSPECS signs by at least two grades; 3. reduction in proptosis by at least 2 mm; 4. reduction in intraocular pressure by at least 2 mm Hg; 5. improvement in CAS by at least two points; 6. improvement in diplopia (disappearance or degrade in degree); 7. improvement in visual acuity by 1 Snellen line.
Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
Time frame: 2years
"Deterioration" of each parameter was defined as follows: 1. increase in lid width by at least 3 mm; 2. increase in any of the class 2 NOSPECS signs by at least two grades; 3. increase in proptosis by at least 2 mm; 4. increase in intraocular pressure by at least 2 mm Hg; 5. increase in CAS by at least two points; 6. increase in diplopia (new onset or upgrade in degree); 7. decrease in visual acuity by 1 Snellen line.
Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
Time frame: 2years
"Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Derived from this study: PubMed 37579198Li Z, Luo Y, Huang Q, Chen Z, Song D, Pan D, Hu S, Jiang W, Cai Q, Feng X, Zhang Q, Weng C, Zhong Q, Zhao T, Li C, Zhang T, Shen J. A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy. J Clin Endocrinol Metab. 2023 Dec 21;109(1):36-45. doi: 10.1210/clinem/dgad476.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucocorticoids in people with Thyroid Associated Ophthalmopathy, run by Jie Shen 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 4 inclusion and 8 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 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jie Shen, Doctor (13808893818, shenjiedr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment (time frame: 2years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107078, which also lists 1 linked publication.
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 2017.