A 24-month, Randomized, Double-masked, Controlled, Multicenter Study Evaluating the Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With Neovascular Age Related Macular Degeneration (AMD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
研究概览
简要总结
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
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
- Triple (Participant, Investigator, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ranibizumab 0.5 mg monthly
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period
干预措施: Ranibizumab (Drug)
Ranibizumab 0.5 mg pro re nata (PRN)
PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
时间窗: Month 3 to month 4 through Month 12
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.
次要结局
- Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24(up to month 24)
- Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12(prior to month 12)
- Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24(Baseline to Month 24)
- Duration of Active Treatment Phase Prior to Month 12(Prior to month 12)
- Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24(Baseline to Month 24)
- Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More(Month 12 and 24)
- Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24(Baseline to Month 24)
- Duration of Active Treatment Phase up to Month 24(up to month 24)
- Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24(Month 3 to month 4 through Month 24)
- Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time(Baseline to 24 months)
- Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time(Baseline to Month 24)