Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
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About
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
Full description
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.
Sex
Ages
Volunteers
Inclusion criteria
- Clinical diagnosis of Graves Orbitopathy
- Clinical activity score higher than 2
- Must be able to swallow tablets
Exclusion criteria
- sight-threatening Graves Orbitopathy
- Diplopia in primary gaze
- Macrolide allergy or intolerance
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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