A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy

Launched by UNIVERSITY OF PISA · Mar 25, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating whether combining orbital radiotherapy (a type of targeted radiation treatment) with high-dose intravenous glucocorticoids (a type of steroid medication) can improve the treatment of Graves' orbitopathy, a condition that causes eye problems due to thyroid issues. The study aims to see if this combination helps patients feel better and improves their quality of life. While high-dose steroids are already a common treatment for this condition, researchers want to find out if adding orbital radiotherapy can make the steroids work better, especially since previous studies mainly focused on oral steroids.

To be eligible for this trial, participants should be between 35 and 75 years old and have a diagnosis of Graves' disease with current eye symptoms lasting no more than a year. They must also have certain eye conditions related to Graves' orbitopathy, but cannot have had major thyroid treatments recently or any contraindications to receiving radiation. If you join the study, you'll receive both treatments and regular check-ups to monitor your progress. This trial is not yet recruiting, but it represents an important step in understanding how to better treat this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A diagnosis of Graves' disease based on the presence of hyperthyroidism (either untreated or treated with antithyroid drugs) associated with detectable anti-TSH receptor autoantibodies
• • 2. No major treatments for hyperthyroidism (thyroidectomy or radioiodine) in the last 3 months
• • 3. Euthyroidism on anti-thyroid medications or L'thyroxine (LT4) since at least 2 months
• • 4. GO symptoms lasting since no more than one year
• • 5. Active GO: CAS ≥ 3 out of 7 (worst eye)
• 6. Moderate or moderately severe GO: at least one of the following signs (worst eye):
• • Exophthalmos ≥ 22 mm
• • Eye muscle involvement with mono-ocular ductions in any direction of gaze of less than 30° or evident dismotility
• • Diplopia according to Gorman score of grades a-c
• • 7. No corticosteroids or immunosuppressive treatment for GO in the last 3 months
• • 8. No contraindication to OR: diabetes, hypertension, retinopathy of any type, glaucoma
• • 9. Male and female patients of age: 35-75 years
• • 10. Effective method of contraception during the whole trial and at least six weeks after last intake of trial drugs (only female of reproducing age)
• • 11. No mental illness that prevent patients from comprehensive, written informed consent
• • 12. Compliant patient, regular follow-up possible
• Exclusion Criteria:
• • 1. Absence of Graves' hyperthyroidism (present or past)
• • 2. Thyroidectomy or radioiodine in the last 3 months
• • 3. Uncontrolled hyperthyroidism or hypothyroidism
• • 4. GO symptoms lasting since more than one year
• • 5. CAS \<3 (worst eye)
• • 6. Optic neuropathy
• • 7. Contraindications to OR (diabetes, retinopathy of any kind)
• • 8. Pregnancy, breast-feeding women
• • 9. No informed consent
• • 10. Acute or chronic liver disease
• • 11. Relevant Malignancy
• • 12. Chronic renal failure or other diseases of any relevance to prevent steroid treatment 13) Corticosteroids or other immunosuppressive agents within last 3 months
• • 13. Recent (≤1 year) history of alcoholism or drug abuse
• • 14. Previous orbital disease other than GO, eye injuries or surgery