CTRI/2013/08/003933已完成Post Marketing Surveillance
Utilizing Ranibizumab intravitreal Injection in a real world setting-A multicentre, open-label, prospective, observational study to evaluate effectiveness and safety of repeated intravitreal injections (IVI) of Lucentis® (ranibizumab) in patients with neovascular age-related macular degeneration (AMD) over a 12-month observational period in a real-world setting.
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Data of response of Ranibizumab un Indian patients with wet AMD
研究概览
简要总结
To evaluate the effectiveness of repeated IVI Lucentis® 0,5 mg in wet xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /AMD defined as mean change in BCVA (Best Corrected Visual Acuity) from Baseline to Month 3 post initiation of Lucentis treatment.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Pms
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •ï¿½Presence of exudative age-related macular degeneration.
- •ï¿½Patients for whome a therapy with Lucentis� is medically indicated.
- •ï¿½Patients who consent to have their data collected.
- •Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care.
排除标准
- •Any contra-indication according to local Summary of Product Characteristics or Prescribing Information (SmPC or PI) of Lucentis®.
结局指标
主要结局
Data of response of Ranibizumab un Indian patients with wet AMD
时间窗: At the end of three months
次要结局
- Number of injections required for vision stability(1 year)
研究者
研究点 (1)
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