Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Decreasing in macular-center thickness measured with optical coherence tomography
研究概览
简要总结
Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.
详细描述
Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.
The conventional therapy includes in first line steroid therapy of which side effects are well known. If the daily steroid dose necessary to control the intra ocular inflammation is superior to 0.3 mg/kg/d a combined therapy to immunosuppressive drug is suggested in order to do a steroid sparing effect. Immunosuppressive drugs include increased infectious risks, hematologic and sterility troubles, and secondary malignancies. Moreover immunosuppressive drugs have a own toxic effect and The classical immunosuppressive drug used in BRC the cyclosporineA has a high level of nephrotoxicity.
That is the reason why immunomodulatory drugs as interferons have been suggested in BRC.
Interferon alpha2 a has been shown efficient in uveitis in Behcet's disease. We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not make the disease worse because of the slow pathologic processus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with Birdshot Retine choroidopathy with macular edema
- •HLA A29 positive
- •Work up of infection or sarcoidosis disease negative
排除标准
- •Pregnancy
- •Alcohol addiction
- •Mood disturbance
- •Medullar, hepatic, renal deficiency
研究组 & 干预措施
A
To analyse the potential therapeutic effect of Interferon alpha2a versus Steroid therapy with a control group for a 4 months period. This short period could not expose to a worsening of the disease because of the slow pathologic processus.
干预措施: interferon alpha 2a (Drug)
A
To analyse the potential therapeutic effect of Interferon alpha2a versus Steroid therapy with a control group for a 4 months period. This short period could not expose to a worsening of the disease because of the slow pathologic processus.
干预措施: prednisone (Drug)
B
干预措施: interferon alpha 2a (Drug)
B
干预措施: prednisone (Drug)
结局指标
主要结局
Decreasing in macular-center thickness measured with optical coherence tomography
时间窗: during 4 months
次要结局
- Increasing in best corrected visual acuity(at 4 months and at the end of the study)
- Final best corrected visual acuity in ETDRS scale(at the 4 month and at the end of the study)
- Retinal vessels inflammation in fluorescein angiography(at the 4 month and at the end of the study)
- Choroidal inflammation in indocyanine green angiography(at the 4 month and at the end of the study)