Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- mean change in visual acuity
研究概览
简要总结
This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.
详细描述
The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study.
The baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion.
The study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
- •Written informed consent
排除标准
- •As described in Lucentis® SmPC
- •Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)
研究组 & 干预措施
Lucentis
Patients administered Lucentis by prescription
干预措施: Lucentis (Drug)
结局指标
主要结局
mean change in visual acuity
时间窗: Baseline, Up to month 24
Visual acuity will be measured according to the method used by each participating physician in his/her routine practice. To be able to integrate different visual acuity assessment methods for analysis, visual acuity assessments performed using Snellen or decimal notation will be converted into an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score equivalent.
mean change in central retinal thickness
时间窗: Baseline, Up to month 24
As central retinal thickness data is optional, this analysis will be performed only if data allow.
次要结局
- Time interval between treatments(Up to 24 months)
- Time interval between visits(Up to 24 months)
- Duration of treatment period(Up to 24 months)
- Maximum period of treatment extension(Up to 24 months)
- Number of retreatments(Up to 24 months)
- Reasons for retreatment(Up to 24 months)
- Number of treatments(Up to 24 months)
- Number of visits(Up to 24 months)
- Monitoring and treatment regimen - Therapy schemes(Up to 24 months)
- Reasons for choice of treatment regimen(Up to 24 months)
- Monitoring and treatment patterns as a function of health insurances(Up to 24 months)
- Number of treatments with Lucentis® vials and pre-filled syringe(Up to 24 months)