NCT01379196

Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Graves Ophthalmopathy

Interventions

Type	Name	Description
DRUG	Azithromycin	Tab. Azithromycin 500 mg PO three times weekly for 3 months

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2011-06-23
• Last updated: 2017-04-27