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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Graves Ophthalmopathy

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin PO three times weekly<br>Tablets Azithromycin 500 mg PO three times weekly for three months | Drug: Azithromycin<br>* Tab. Azithromycin 500 mg PO three times weekly for 3 months<br>* Other names: AZITRO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical activity score between baseline and after three months | Change in the clinical activity score between baseline and after 3 months (Clinical Activity Score is a validated index of Graves Ophthalmopathy that assigns one point to the presence of: 1.spontaneous retrobulbar pain, 2. pain on up/downgaze, 3. redness of eyelids, 4. redness of conjunctiva, 5. swelling of eyelids, 6. inflammation of caruncle/plica, 7. chemosis). The maximal clinical activity score is thus 7. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of extraocular muscle thickening | Ultrasonic measurement of extraocular muscle thickening | 3 months | 
| ANTI TSH Receptor antibody levels | Serum measurements of ANTI TSH Receptor antibody levels | 0, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graves Orbitopathy, Macrolide antibiotics, Inflammation, Clinical Activity Score