Status:
NOT_YET_RECRUITING
A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Graves Ophthalmopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 clar...
Detailed Description
The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.
Eligibility Criteria
Inclusion
- Age 18-65 years old;
- diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;
- Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;
- without receiving immunosuppressive therapy for thyroid eye disease before.
Exclusion
- (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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06510114
Start Date
July 1 2024
End Date
December 1 2026
Last Update
July 19 2024
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