Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
研究概览
简要总结
To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -
排除标准
- •Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis
研究组 & 干预措施
Dexamethasone-implant (Group 1)
Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
干预措施: Dexamethasone implant (Drug)
Bevacizumab/Dexamethasone-implant (Group 2)
Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection.
干预措施: Dexamethasone implant (Drug)
Bevacizumab/Dexamethasone-implant (Group 2)
Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
时间窗: 12 months
次要结局
- Lens opacity(12 months)
- Central retinal thickness(12 months)
- Saftey of procedure(12 months)
研究者
Wolfgang Mayer
MD
Ludwig-Maximilians - University of Munich