Graves Ophthalmopathy Clinical Trial
Official title:
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
The purpose of this study is to examine the effects of Azithromycin (a macrolide class
antibiotic), given three times weekly, for patients with active moderate-severe, non
sight-threatening, Graves Orbitopathy.
Indices for follow-up will include:
- Clinical activity score
- Anti-TSH receptor antibody levels
- Thickening of extraocular muscles per ultrasound
- Quality of life score for Graves Orbitopathy patients
Graves Orbitopathy (GO) is an autoimmune inflammatory disorder causing visual morbidity,
cosmetic morbidity and interference with quality of life. The disease has an inflammatory
stage and a non-inflammatory, fibrotic stage.
Treatment of inflammatory stage moderate-severe GO includes steroids, as recommended by the
EUGOGO consortium. However, the length of treatment needed and the risk of steroid
side-effects may lead to multiple undesired treatment induced morbidity.
Antibiotics of the macrolide group posses known immune-modulatory effects that are separate
from their antibacterial mode of action. This mode of action has lead to the routine use of
macrolide antibiotics for delaying graft rejection following lung transplants.
We propose to test the effect of this class of antibiotics for non-sight threatening,
moderate-severe, inflammatory GO.
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