Enrolling by invitation
Not applicable
Multi-center Prospective Clinical Study on Glucocorticoid Pulse Therapy for Graves' Ophthalmopathy (GO)
Condition(s) studied
Graves Ophthalmopathy
Investigational drug(s) / intervention(s)
High-Dose MethylprednisoloneLow-Dose Methylprednisolone
High-Dose Methylprednisolone: Methylprednisolone 500mg, administered intravenously once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
Low-Dose Methylprednisolone: Methylprednisolone is administered at a dose of 1mg/kg, given as an intravenous injection once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
Study summary
This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the efficacy and safety of the two groups. Additionally, this study will extend the follow-up to 48 weeks to observe the recurrence rate after treatment in both groups, exploring the heterogeneity of the active course of Graves' ophthalmopathy.
Eligibility
Inclusion Criteria:
1. Voluntarily accept the study and sign the informed consent form.
2. Age between 25 and 70 years old at the time of enrollment, both males and females are eligible.
3. Newly diagnosed Graves' ophthalmopathy, moderate to severe active patients. The criteria for moderate to severe GO are: ① eyelid retraction ≥2mm; ② moderate to severe involvement of orbital soft tissues; ③ proptosis ≥20mm; ④ periodic or persistent diplopia. Meeting one of the above four criteria is sufficient.
The criteria for active GO are: CAS score ≥4 points. Scoring criteria: ① spontaneous retro-ocular pain; ② pain on eye movement; ③ conjunctival congestion; ④ eyelid congestion; ⑤ chemosis of the conjunctiva; ⑥ swelling of the caruncle; ⑦ eyelid edema. One point is recorded for each of the above seven symptoms if present, and zero if absent.
4. The onset of Graves' ophthalmopathy does not exceed 12 months, and those who have not been treated with glucocorticoids or other immunosuppressive agents.
5. Women of childbearing age must use effective contraceptive measures.
6. At the time of screening, hyperthyroidism in the study subjects should be basically controlled. Thyroid function should be normal or only mildly abnormal, defined as FT4 and FT3 levels within 50% of the upper and lower limits of the normal range. Mild thyroid dysfunction should be corrected as much as possible, and a normal thyroid function state should be maintained throughout the clinical trial period.
Exclusion Criteria:
1. Pregnant women, women who are breastfeeding, or women planning to become pregnant during the trial period.
2. Severe cardiac diseases such as myocardial infarction, unstable angina, and chronic heart failure.
3. Known liver diseases, or alanine transaminase (ALT) levels more than 1.5 times the upper limit of normal.
4. Chronic kidney disease, or serum creatinine \>135 umol/L (\>1.5 mg/dL).
5. Individuals with diabetes, and HbA1c \>9.0%.
6. Individuals with a history of alcohol abuse or drug use.
7. Subjects with a white blood cell count \<4.0×10\^9/L, or a platelet count \<80×10\^9/L.
8. Significant anemia (hemoglobin levels \<110 g/L in males, \<100 g/L in females).
9. Patients with psychiatric disorders, or those who are non-cooperative.
10. Individuals with optic nerve involvement requiring orbital decompression surgery. Defined as a decrease in vision by more than two lines in the past six months, or new visual field defects, or color vision deficiencies.
11. Corneal ulcers, contraindications for glucocorticoid treatment.
Primary outcome measure(s)
- Overall Response Rate, ORR — From enrollment to the end of treatment at 24 weeks
The percentage of subjects with improvement in Graves' ophthalmopathy at week 24.
Trial sites (3)
| Facility | City | Region | Status |
| Shanghai Changzhen Hospital |
Shanghai |
Shanghai Municipality |
|
| Shanghai Changhai Hospital |
Shanghai |
Shanghai Municipality |
|
| Shanghai Longhua Hospital |
Shanghai |
Shanghai Municipality |
|
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