NCT01318941已完成不适用
LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30,490
- 试验地点
- 1
- 主要终点
- Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
研究概览
简要总结
This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, within age limits as defined by local regulations and local product label, who have previously been treated with, who are currently being treated with or initiating treatment with ranibizumab for any approved indication included in the local product label
- •Willing and able to provide informed written consent personally or by legal proxy
排除标准
- •Simultaneous participation in a study that includes administration of any investigational drug or procedure
- •Systemic or ocular treatment with any VEGF inhibitor other than ranibizumab in the 90 days prior to enrollment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ranibizumab
干预措施: Ranibizumab (Other)
结局指标
主要结局
Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
时间窗: Defined time periods during study duration from FPFV until 30 days after LPLV
Mean visual acuity at quarterly intervals for the primary treated eye set
时间窗: Quarterly intervals from baseline visit during study duration (5 years)
Mean Visual Acuity (VA) and mean change in VA
时间窗: 3,6, and 12 months from the baseline visit, and annually thereafter
次要结局
- "National Eye Institute Visual Functioning Questionnaire-25" change from baseline(annually)
- Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination(Over time during study duration (5 years))
- Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores(Over time during study duration (5 years))
- Number of ranibizumab injections administered per patient, per eye, and per person-year(annually)
- Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the time the patient signed the informed consent until 30 days after study discontinuation)
研究者
研究点 (1)
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