Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in central retinal thickness
研究概览
简要总结
The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is:
How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.
详细描述
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 1 or type 2 diabetes
- •diabetic macular edema involving the foveal center with CRT >300 μm measured by OCT
- •at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF
排除标准
- •uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time
- •previous IDI
- •any condition precluding adequate fundus visualization
- •uncontrolled glaucoma
- •papillary excavation ≥ 0.7
研究组 & 干预措施
Intravitreal dexamethasone implant
All patients were included here and received one intravitreal dexamethasone implant 0.7mg
干预措施: Intravitreal dexamethasone implant (Drug)
结局指标
主要结局
Change in central retinal thickness
时间窗: Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Difference among the baseline and the posterior measurements of the CRT with OCT
次要结局
- Change in Best Corrected Visual Acuity(Prospective: from baseline to 1 month post IDI)