Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
1 other identifier
interventional
200
1 country
1
Brief 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. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 18, 2017
April 1, 2017
3 years
March 8, 2017
April 16, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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: 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.
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: 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.
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.
2years
Study Arms (4)
Group Ia
EXPERIMENTALI: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
EXPERIMENTALI: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
EXPERIMENTALII: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
EXPERIMENTALII: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.
Interventions
Intravenous Glucocorticoids (GCs)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jie Shenlead
- The Fifth Affiliated Hospital of Southern Medical Universitycollaborator
- Huadu District People's Hospital of Guangzhoucollaborator
- Zhujiang Hospitalcollaborator
Study Sites (1)
the Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (1)
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.
PMID: 37579198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President;Doctoral Supervisor
Study Record Dates
First Submitted
March 8, 2017
First Posted
April 11, 2017
Study Start
October 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2021
Last Updated
April 18, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share