A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment for Graves orbitopathy, a condition that can cause eye problems due to thyroid disease. Researchers want to find out if giving patients intravenous methylprednisolone (a type of steroid) every day is as effective and safe as giving it once a week. They will compare these two treatment schedules to see which one helps patients feel better and have fewer side effects.

To participate in this trial, you need to be between 18 and 65 years old and have been diagnosed with moderate to severe thyroid eye disease. It's important that your thyroid has been stable for at least two months, and you shouldn't have received certain other treatments recently. If you join the study, you will receive either the daily or weekly treatment, and the team will monitor your progress closely. This trial is not yet recruiting participants, but it aims to clarify the best way to use this therapy for people with Graves orbitopathy.

Gender

ALL

Eligibility criteria

• 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