Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change in clinical activity score between baseline and after three months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Graves Orbitopathy
- •Clinical activity score higher than 2
- •Must be able to swallow tablets
排除标准
- •sight-threatening Graves Orbitopathy
- •Diplopia in primary gaze
- •Macrolide allergy or intolerance
研究组 & 干预措施
Azithromycin PO three times weekly
Tablets Azithromycin 500 mg PO three times weekly for three months
干预措施: Azithromycin (Drug)
结局指标
主要结局
Change in clinical activity score between baseline and after three months
时间窗: 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.
次要结局
- ANTI TSH Receptor antibody levels(0, 3 and 6 months)
- Measurement of extraocular muscle thickening(3 months)
研究者
kalish hadas
Chief, Neuro-Ophthalmology Unit
Rabin Medical Center