NCT01095809终止3 期
Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- Macular Thickness Measurements Using Stratus Optical Coherence Tomography
研究概览
简要总结
The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema
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
- •adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema
- •with macular thickness > 250 micra using OCT
- •visual acuity at least 20/200
- •with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease
- •patient that can follow study's requirements
- •patient who consents to participate
排除标准
- •presence of corneal or crystalline opacity preventing observation of fundus of eye
- •patients requiring ocular surgery in next 3 months
- •pregnancy and child breastfeeding
- •previous history of glaucoma
- •on treatment woth an experimental ocular drug
- •previous thromboembolism or receiving oral anticoagulant treatment
- •vitrectomy
- •patients with proved tractional macular pathology associated to macular oedema
研究组 & 干预措施
bevacizumab
Experimental
intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
干预措施: bevacizumab (Drug)
triamcinolone acetonide
Experimental
intravitreous triamcinolone 2 mg, frequency: 3 months
干预措施: triamcinolone acetonide (Drug)
结局指标
主要结局
Macular Thickness Measurements Using Stratus Optical Coherence Tomography
时间窗: 48 weeks
次要结局
- opacity crystalline(48 weeks)
- visual acuity(48 weeks)
- intraocular pressure(48 weeks)
研究者
研究点 (5)
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