A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
研究概览
简要总结
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
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
- Single (Participant)
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
- •Male or female age 18 years or older
- •Type 1 or type 2 diabetes
- •BCVA score of >24 and <78 letters
- •Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns
排除标准
- •Anti-VEGF intravitreal treatment in last 4 weeks
- •Intravitreal steroid treatment in the last 8 weeks
- •PRP or Focal laser in last 4 months
- •Active iris neovascularization
研究组 & 干预措施
Bevacizumab alone
干预措施: Bevacizumab (Drug)
Combined group
Bevacizumab plus Ozurdex
干预措施: Bevacizumab (Drug)
Combined group
Bevacizumab plus Ozurdex
干预措施: dexamethasone intravitreal implant (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
时间窗: baseline to 12 month
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
OCT CST
时间窗: change in OCT CST from baseline to twelve months
change in optical coherence tomography central subfield thickness
次要结局
未报告次要终点
研究者
Raj K. Maturi, MD
PI
Maturi, Raj K., M.D., P.C.