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Comparison of the Effectiveness and Tolerability of Orbital Radiotherapy Associated with or without Intravenous Glucocorticoids in the Management of Moderate-Severe Graves’ Ophthalmopathy: A Prospective, Single-Blind, Randomized Clinical Study

Comparison of the Effectiveness and Tolerability of Orbital Radiotherapy Associated with or without Intravenous Glucocorticoids in the Management of Moderate-Severe Graves’ Ophthalmopathy: A Prospective, Single-Blind, Randomized Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002263
Enrollment
Unknown
Registered
2012-06-12
Start date
2012-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves’ ophthalmopathy

Interventions

Group A:Orbital Radiotherapy
Group B:Orbital Radiotherapy combined with Intravenous Glucocorticoids

Sponsors

Department of Endocrinology, Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosised as the active moderate-severe Graves’ Ophthalmopathy based on the EUGOGO-ATA diagnostic criteria; 2. age from 25-60 years old; 3. Male and female; 4. the duration of Graves’ Ophthalmopathy less than 18 months; 5. Thyroid function is under control (FT4 is normal); 6. sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Vision-threatening Graves' ophthalmopathy; 2. patients with Optic atrophy, cataracts and retinopathy; 3. CAS score70; 5. the duration of Graves’ Ophthalmopathy more than 18 months; 6. Clinical hyperthyroidism or hypothyroidism(not include normal serum free T4 levels); 7. Use of intravenous corticosteroid treatment within 12 months; 8. Use of oral corticosteroid treatment within 6 months; 9. Use of Orbital Radiotherapy treatment within 12 months; 10. Pregnancy and lactating women; 11. Abnormal liver function (Transaminase higher than 2.5 times the upper limit of normal) and abnormal renal function(blood Scr >136µmol/L); 12. Active hepatitis; 13. Severe hypertension (Grade II or more than Grade II); 14. Patients with dia 23)betic retinopathy or the use of insulin therapy or poor glycemic control (HbA1c > 8%) or acute metabolic disorders; 15. Active peptic ulcer; 16. Intraocular pressure (glaucoma or green eyelashes syndrome); 17. Active infection (especially tuberculosis); 18. Patients with a history of severe cardiovascular disease (heart failure, coronary heart disease, stroke); 19. Osteoporosis; 20. Other thyroid diseases, including: thyroid tumors (benign and malignant), Hashimoto's thyroiditis, subacute thyroiditis, primary hypothyroidism; 21. Cancer (including hematological neoplasms); 22. Moderate to severe anemia and leukopenia; 23. Cachexia, and other low resistance person; 24. Disabled use of Glucocorticoid due to other disease; 25. Reluctant to sign the informed consent or unable to complete the entire course of treatment.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms;Clinical severity assessment;Clinical activity assessment;Orbital MRI examinations;self-assessment evaluation;Safety assessment;

Countries

China

Contacts

Public ContactYaoming Xue
yaomingxue@126.com+86 020 61641631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026