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

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Azithromycin

Criteria

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