A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy - Trial NCT03098225

Timeline & Enrollment

Primary Outcome

Comparison of overall GO outcome determined using a composite evaluation

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.

ICD-10 Classifications