Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 4
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
研究概览
简要总结
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
- •Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
- •Visual acuity between 20/320 and 20/40
排除标准
- •Active ocular infection
- •Contraindication to pupil dilation in either eye
- •Eye surgery including cataract surgery and/or laser of any type within 3 months
研究组 & 干预措施
700 ug dexamethasone and ranibizumab
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
干预措施: 700 ug dexamethasone (Drug)
700 ug dexamethasone and ranibizumab
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
干预措施: ranibizumab (Biological)
ranibizumab and sham
Intravitreal injection of ranibizumab and Sham into study eye
干预措施: ranibizumab (Biological)
ranibizumab and sham
Intravitreal injection of ranibizumab and Sham into study eye
干预措施: sham (Other)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
时间窗: Baseline, Month 12
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
次要结局
- The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12(Baseline, Month 12)
- Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography(Baseline, Month 12)
- Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography(Baseline, Month 12)