Graves Ophthalmopathy
Conditions
Keywords
Hyperthyroidism, Graves Ophthalmopathy, glucocorticoid
Brief summary
Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.
Detailed description
The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.
Interventions
DRUGmethylprednisolone(daily scheme)
0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg/day for 4 weeks and then the dose was tapered by 5 mg/day every 2-4 weeks.
DRUGmethylprednisolone(weekly scheme)
0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g/week over the following 6 weeks.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants with active moderate-to-severe GO were randomized at a ratio of 1:1 to receive glucocorticoid therapy for 12 weeks on a weekly protocol or daily scheme.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years old; 2. diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points; 3. Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment; 4. without receiving immunosuppressive therapy for thyroid eye disease before.
Exclusion criteria
(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the overall response rate at 24 week | 24 week | Response was defined as an improvement in at least two of the following four criteria were present, and the contralateral eye disease did not worsen: (1) the width of the eyelid was reduced by ≥2 mm; (2) The five scores of eyelid congestion, eyelid edema, conjunctival congestion, conjunctival edema and carunculae lacrimalis swelling in CAS decreased by ≥1 point; (3) The regression of exophthalmos ≥2 mm; (4) Increased eye movement ≥8° or improved diplopia ≥ grade I (continuous to interrupted, interrupted to brief, brief to none). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of clinical activity score (CAS) from baseline to 24 week | 24 week | changes of clinical activity score (CAS) from baseline to 24 week |
| changes of quality of life score (QoF-s) from baseline to 24 week | 24 week | changes of quality of life score (QoF-s ) |
| changes of exophthalmos from baseline to 24 week | 24 week | changes of exophthalmos from baseline to 24 week |
| changes of width of the eyelid from baseline to 24 week | 24 week | changes of width of the eyelid from baseline to 24 week |
| changes of diplopia grade from baseline to 24 week | 24 week | changes of diplopia grade from baseline to 24 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of blood pressure from baseline to 24 week | 24 week | Changes of blood pressure from baseline to 24 week |
| Changes of weight from baseline to 24 week | 24 week | Changes of weight from baseline to 24 week |
| Changes of fasting blood glucose from baseline to 24 week | 24 week | Changes of fasting blood glucose from baseline to 24 week |
| Changes of serum low density lipoprotein cholesterol | 24 week | Changes of low density lipoprotein cholesterol from baseline to 24 week |
| Changes of serum triglyceride | 24 week | Changes of serum triglyceride from baseline to 24 week |
Contacts
Primary ContactShuo Lin
Outcome results
None listed