A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy (NCT03098225) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy
120 participantsStarted 2024-01-01
Plain-language summary
Graves' orbitopathy (GO) is a disfiguring and disabling disease that profoundly impairs the quality of life of affected patients. High dose intravenous (iv) glucocorticoids (GC) (ivGC) is a well established, widely used treatment for active GO. The use of systemic glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions, resulting in an overall beneficial effect ranging from \~35 to \~60% of patients in various studies. The intravenous route of administration has been shown to be superior to the oral route, both in terms of GO outcome and side effect profile. The combination of ivGC and orbital radiotherapy (OR) is used routinely in patients with moderate-severe, active GO, as a second-line treatment, as also recommended in the recent Guidelines published by the European Thyroid Association/European Group on Graves' Orbitopathy. Thus, the majority of studies have shown that OR increases the response rate to GC. Those studies were performed using oral GC, whereas it is not known whether OR potentiate also the effects of ivGC.
The present study is aimed at determining whether OR potentiate the effects of ivGC in the treatment of moderately severe and active GO, in terms of GO outcome and quality of life. A possible extension of the study can be foreseen, aimed at investigating the very long time GO outcome.
Who can participate
Age range35 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. No major treatments for hyperthyroidism (thyroidectomy or radioiodine) in the last 3 months
✓. Euthyroidism on anti-thyroid medications or L'thyroxine (LT4) since at least 2 months
✓. GO symptoms lasting since no more than one year
✓. Active GO: CAS ≥ 3 out of 7 (worst eye)
✓. Moderate or moderately severe GO: at least one of the following signs (worst eye):
✓. No corticosteroids or immunosuppressive treatment for GO in the last 3 months
✓. No contraindication to OR: diabetes, hypertension, retinopathy of any type, glaucoma
Exclusion criteria
✕. Absence of Graves' hyperthyroidism (present or past)
What they're measuring
1
Comparison of overall GO outcome determined using a composite evaluation