Combined Radiotherapy and Intravenous Steroids for Early Progressive Thyroid Eye Disease
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Thyroid eye disease is an autoimmune disorder affecting approximately 50% of individuals with
autoimmune thyroid diseases resulting in enlargement of ocular muscles and may lead to
congestion of the eyelids and ocular surface, ocular movement restriction and double vision,
and optic nerve compression and loss of vision.
First line medical therapy is oral or intravenous corticosteroids (CS), which several studies
have shown results in reduction of soft tissue congestion, but some studies suggesting that
ocular restriction or visual loss may still occur in spite of CS therapy.i
External beam radiotherapy (XRT) is second line therapy but is controversial, with some
studies suggesting benefit in preventing onset of double vision or optic nerve compression
while other studies suggest it has no benefit. Most proponents of XRT for TED believe that it
is most effective early in the disease evolution. XRT has been shown to be a safe therapy
with few side-effects, although retinopathy changes have developed in a small percentage of
diabetics and its use is avoided for diabetics.
Combined oral prednisone and XRT has been shown to be more effective in reducing soft tissue
inflammation and motility complications than either monotherapy in two different studies.
To date there have been no trials comparing combined XRT and iv CS with iv CS alone for early
progressive TED to identify potential benefit in reducing the severity of motility disorders
or preventing the onset of dysthyroid optic neuropathy. That is the purpose of this study.