A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 599
- 主要终点
- Cumulative Response Rate of 15 or More Letter Improvement
研究概览
简要总结
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older with macular edema resulting from retinal vein occlusion
- •Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- •Visual acuity in other eye no worse than 20/200
排除标准
- •Known anticipated need for ocular surgery within next 12 months
- •History of glaucoma or current high eye pressure requiring more than 1 medication
- •Diabetic retinopathy
- •Uncontrolled systemic disease
- •Known steroid-responder
- •Use of systemic steroids
- •Use of warfarin/heparin
研究组 & 干预措施
350 µg Dexamethasone followed by 700 µg Dexamethasone
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
干预措施: 350 µg Dexamethasone (Drug)
700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
干预措施: 700 µg Dexamethasone (Drug)
350 µg Dexamethasone followed by 700 µg Dexamethasone
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
干预措施: 700 µg Dexamethasone (Drug)
Sham Injection followed by 700 µg Dexamethasone
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
干预措施: 700 µg Dexamethasone (Drug)
Sham Injection followed by 700 µg Dexamethasone
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
干预措施: Sham Injection (Other)
结局指标
主要结局
Cumulative Response Rate of 15 or More Letter Improvement
时间窗: Up to 180 Days
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
次要结局
- Change From Baseline in Retinal Thickness in the Study Eye(Baseline, Day 90, Day 180)
- Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye(Day 90, Day 180)
- Percentage of Patients With a Change From Baseline in BCVA by Category(Baseline, Day 180)