Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual acuity, no of treatments, duration of efficacy
研究概览
简要总结
Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.
详细描述
Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.
In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years
排除标准
- •recent treatment with laser photocoagulation or intravitreal drugs
结局指标
主要结局
Visual acuity, no of treatments, duration of efficacy
时间窗: 12 months
次要结局
- intraocular pressure, retinal thickness(12 months)