An Observational Study to Assess the Use of Intravitreal Aflibercept Injections in a Routine "Treat and Extend" Regimen in Treatment-naïve Patients Diagnosed With Wet Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
研究概览
简要总结
The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.
详细描述
Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of wet age-related macular degeneration.
- •No prior therapy for wet age-related macular degeneration.
- •Patients for whom the decision to initiate treatment with IVT-AFL in a T&E regimen was made as per routine clinical practice.
- •Patient age >55 years of age
排除标准
- •Participation in an investigational program with therapeutical interventions outside of clinical routine practice.
- •Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
- •Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye
研究组 & 干预措施
Aflibercept
Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
结局指标
主要结局
Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
时间窗: Baseline and at 12 months
mean change in ETDRS letters
次要结局
- Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)(Baseline and at 24 months)
- Mean change in best-corrected visual acuity in relation to the number of injections administered(Baseline and at 12 months; Baseline and at 24 months)
- Mean interval between injections(At 12 and 24 months)
- Mean changes from baseline in central retinal thickness (CRT)(Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months)
- Reasons for termination of therapy (including subsequent therapy at time of discontinuation)(At 12 and 24 months)
- Severity of disease reactivation(Baseline and at 12 months; Baseline and at 24 months)
- Frequency of disease reactivation(Baseline and at 12 months; Baseline and at 24 months)
- Reasons for the interval length(At 12 and 24 months)
- Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline(Baseline and at 12 months; Baseline and at 24 months)
- Changes from baseline in retinal fluid(Baseline and at 12 months; Baseline and at 24 months)