A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 71
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
研究概览
简要总结
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.
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
- 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
- •Diagnosis of macular edema
- •Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye
排除标准
- •Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
- •Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
- •Any active ocular infection in either eye
研究组 & 干预措施
OZURDEX®
OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
干预措施: dexamethasone implant (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
时间窗: Baseline, Month 6
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
次要结局
- Percentage of Participants Receiving a Third Injection(12 Months)
- Time to Third Injection(12 Months)
- Change From Baseline in CRT at Month 12(Baseline, Month 12)
- Change From Baseline in CRT at Each Visit(Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Change From Baseline in Central Retinal Thickness (CRT) at Month 6(Baseline, Month 6)
- Change From Baseline in BCVA at Month 12(Baseline, Month 12)
- Change From Baseline in BCVA at Each Visit(Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA(Baseline, Months 6 and 12)
- Percentage of Participants Receiving a Second Injection(12 Months)
- Time to Second Injection(12 Months)
- Percentage of Participants Who Received Laser Treatments(12 Months)