Open-label Phase-4 Study to Examine the Change of Vision-related Quality of Life in Subjects With Diabetic Macular Edema (DME) During Treatment With Intravitreal Injections of 2 mg Aflibercept According to EU Label for the First Year of Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 560
- 主要终点
- Change From Baseline to Week 52 in NEI VFQ-25 Total Score
研究概览
简要总结
To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 1 or 2 diabetes mellitus
- •Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
- •Decrease in vision determined to be primarily the result of DME in the study eye
- •BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
排除标准
- •Pregnancy and lactation
- •Mismatch with inclusion criteria
研究组 & 干预措施
Arm 1 / Quality of Life
Aflibercept treatment in subjects with diabetic macular edema (DME)
干预措施: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Change From Baseline to Week 52 in NEI VFQ-25 Total Score
时间窗: Baseline, Week 52
National eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the "NEI VFQ-25 Scoring Algorithm - August 2000". The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.
次要结局
- Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)(Baseline, Week 52)
- Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale(Baseline, Week 52)
- Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale(Baseline, Week 52)
- Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP)(Baseline, Week 52)
- Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score])(Baseline, Week 52)