Use of Azithromycin as Immunomodulatory Therapy in Grave'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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy|
- Change in clinical activity score between baseline and after three months [ Time Frame: Three months ] [ Designated as safety issue: No ]
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.
- Measurement of extraocular muscle thickening [ Time Frame: 3 months ] [ Designated as safety issue: No ]Ultrasonic measurement of extraocular muscle thickening
- ANTI TSH Receptor antibody levels [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]Serum measurements of ANTI TSH Receptor antibody levels
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Azithromycin PO three times weekly
Tablets Azithromycin 500 mg PO three times weekly for three months
Tab. Azithromycin 500 mg PO three times weekly for 3 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379196
|Principal Investigator:||Hadas Kalish, MD||Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel|