A retrospecTive and Prospective Non-Interventional Study to Assess the Clinical pracTice in Real Life for Patients With Wet AMD Refractory to raNibizumab and Switching to Aflibercept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 236
- 主要终点
- Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm))
研究概览
简要总结
The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.
The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab
详细描述
The study is both retrsopective and prospective to collect local real life data on patients under routine treatment.
The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Man or woman > 18 years old
- •Patient with wAMD previously treated with ranibizumab (for less than 12 months before initiation of Aflibercept)
- •Refractory to ranibizumab (defined by persistent fluid despite a treatment conducted according to the HAS French recommendations with at least 3 loading doses injections)
- •Patient who switched to aflibercept (Eylea) between 1st of January 2014 and 30th June 2015
- •Written informed consent given
排除标准
- •Patient who do not meet the local indication criteria for aflibercept treatment. Contraindications listed in the local SmPC (Summary of Product Characteristics) have to be considered
- •Recurrent patients with wAMD previously treated with ranibizumab and switched to aflibercept because of a high recurrence rate (recurrent patients described by Yonegawa et al.in AJO (American Journal of Ophthalmology )2013= exudation suppressed but high rate of injections)
- •Patient who have been previously treated by any macular laser Visudyne/PD (Photodynamic therapy)
- •Patient with a Visual Acuity (VA) <1/10
- •Patient with Fibrosis involving Macula
- •Patient with atrophic AMD
- •Patient with any other retinal disease as myopia, diabetic retinopathy, diabetic macular oedema,chorioretinal anastomosis (CRA),, angioid streaks
- •Patients taking part in an interventional study at the time of enrolment
研究组 & 干预措施
Group 1
According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection
干预措施: Aflibercept (EYLEA, BAY-86-5321) (Drug)
结局指标
主要结局
Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm))
时间窗: Between initial visit and 12 month follow up visit
The 12 month follow up visit is the visit 12 month after the first injection of aflibercept
次要结局
- Proportion of patients with dry-OCT(Between initial visit and up to 1 year maximum)
- Proportion of patients with less than 15 letters loss(Between initial visit and up to 1 year maximum)
- Mean change in Central retinal thickness in µm (OCT)(Between initial visit and up to 1 year maximum)
- Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters(Between initial visit and up to 1 year maximum)
- Mean duration of treatment with ranibizumab before initiation of aflibercept(Between initial visit and up to 1 year maximum)