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Patients were not interested in enrolling
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin PO three times weekly | Experimental | Tablets Azithromycin 500 mg PO three times weekly for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Tab. Azithromycin 500 mg PO three times weekly for 3 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadas Kalish, MD | Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel | Principal Investigator |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| 0, 3 and 6 months |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |