Graves Ophthalmopathy
Conditions
Keywords
Graves Orbitopathy, Macrolide antibiotics, Inflammation, Clinical Activity Score
Brief 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.
Interventions
DRUGAzithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical activity score between baseline and after three months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of extraocular muscle thickening | 3 months | Ultrasonic measurement of extraocular muscle thickening |
| ANTI TSH Receptor antibody levels | 0, 3 and 6 months | Serum measurements of ANTI TSH Receptor antibody levels |
Outcome results
None listed