Multi-center Prospective Clinical Study on Glucocorticoid Pulse Therapy for Graves' Ophthalmopathy (GO)

Launched by ZOU JUNJIE · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called glucocorticoid pulse therapy for people with Graves' ophthalmopathy, a condition that affects the eyes due to thyroid disease. The trial will include patients who have recently been diagnosed with moderate to severe forms of this eye condition. Participants will be divided into two groups: one will receive a high dose of medication, and the other will get a lower dose, both for 24 weeks. The goal is to see how effective and safe each dose is, as well as to check on patients for up to 48 weeks after treatment to see if their symptoms come back.

To be eligible for the trial, participants should be between 25 and 70 years old, have active Graves' ophthalmopathy with specific eye symptoms, and must not have been treated with certain medications before. Women of childbearing age need to use birth control during the study. Those with serious health issues, such as severe heart, liver, or kidney problems, or certain eye conditions, will not be able to participate. If you join, you can expect regular visits to the clinic for treatment and check-ups, helping researchers learn more about how to manage this condition effectively.

Gender

ALL

Eligibility criteria

• 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.