NCT03521895已完成不适用
An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies
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
- 发起方
- Bayer
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline
研究概览
简要总结
The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS.
The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with wet AMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC)
- •Documentation of at least one Aflibercept (Eylea) injection
- •Assessment of at least one visual acuity measurement with available VA letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available VA letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection RAINBOW
- •Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
- •Patient who meet the local indication criteria for Eylea treatment
- •At least one BCVA after the 1st Eylea injection
- •BCVA at baseline
- •Patient with no history of retinal disease
- •Patient not previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye (for fellow eye allowed).
- •For patients with both eyes treated, the eye firstly treated at initial visit will be considered as study eye. If both eyes are treated during initial visit, the treated eye with worst Best-Corrected Visual Acuity (BCVA) at M0 will be retained. If the two conditions are similar the study eye is the Right eye by convention
- •Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled Exclusion criteria PERSEUS
- •Exclusion criteria as listed in the local SPC
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- •All patients previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye will additionally be excluded for this integrated analysis
- •Any concomitant therapy with another agent to treat wet AMD in the study eye RAINBOW
- •Patient who does not meet the local indication criteria for Eylea treatment. Contraindications listed in the SmPCs must be taken into account
- •Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
- •Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
- •Patient taking part in an interventional study at the time of enrolment
排除标准
- 未提供
研究组 & 干预措施
Treatment naïve wAMD
Treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW
干预措施: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline
时间窗: At baseline and 12 months
次要结局
- Proportion of patients gaining 5, 10 or 15 or more letters(At 12 months)
- Proportion of patients with ≥70 letters VA(At 12 months)
- Mean time from diagnosis by the treating physician to start of treatment(At baseline)
- Proportion of patients with ≥73 letters VA(At 12 months)
- Proportion of patients losing 5, 10 or 15 or more letters(At 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Integrated Program for Children With Severe Acute Malnutrition in Madhya Pradesh, IndiaSevere MalnutritionNCT01917734Victor M. Aguayo2,740
尚未招募
Unknown
A Study to Evaluate the Effectiveness of Integrative Healthcare Services by Establishing a Cohort -Registry of Rheumatoid Arthritis PatientsKCT0009627Wonkwang University Hospital40
尚未招募
Unknown
A Study to Evaluate the Effectiveness of Integrative Healthcare Services by Establishing a Cohort -Registry to improve the quality of life on Fibromyalgia PatientsKCT0009626Wonkwang University Jangheung Integrative Medical Hospital40
Unknown
不适用
Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in TaiwanAcute Myocardial InfarctionStable AnginaNCT01357096Kaohsiung Medical University Chung-Ho Memorial Hospital400
Unknown
不适用
Safe Motherhood Promotion and Newborn SurvivalNeonatal DeathMaternal DeathNCT03032276International Centre for Diarrhoeal Disease Research, Bangladesh50,400