A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline Visual Acuity at 6 Months
研究概览
简要总结
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
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
- 是
入选标准
- •male or female age 18 years or older
- •Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
- •Best correct visual acuity of greater than 24 and less than 80
- •Presence of macular edema defined as OCT central subfield thickness of >250
排除标准
- •intravitreal anti-VEGF treatment in study eye within six weeks of baseline
- •intravitreal steroid treatment in the study eye within eight weeks of baseline visit
- •PRP in the study eye within 4 month of baseline visit
- •Active iris neovascularization in study eye
- •Uncontrolled systemic disease
- •Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications
研究组 & 干预措施
Group 1
Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
干预措施: Avastin (Drug)
Group 2
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
干预措施: Osurdex (Drug)
Group 2
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
干预措施: Avastin (Drug)
结局指标
主要结局
Change From Baseline Visual Acuity at 6 Months
时间窗: 6 months
Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
次要结局
- Number of Injections Needed(baseline to 6 months)
- Change in Macular Thickness and Macular Volume(6 months)
研究者
Raj K. Maturi, MD
President
Maturi, Raj K., M.D., P.C.