A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 466
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The following is an abbreviated list of inclusion criteria:
- •Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- •Decrease in vision determined to be primarily the result of DME in the study eye
- •BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
排除标准
- •The following is an abbreviated list of exclusion criteria:
- •Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
- •Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
- •Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
- •Active proliferative diabetic retinopathy (PDR) in the study eye
- •Uncontrolled diabetes mellitus
- •Only 1 functional eye even if that eye is otherwise eligible for the study
研究组 & 干预措施
Macular Laser Photocoagulation Treatment (Control)
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
干预措施: Macular Laser Photocoagulation (Procedure)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
干预措施: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) (Drug)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
干预措施: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
时间窗: Baseline and Week 52
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
次要结局
- Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF(Baseline and Week 52)
- Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF(Baseline and Week 52)
- Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF(Baseline and Week 52)
- Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF(Baseline and Week 52)
- Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF(Baseline and Week 52)
- Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF(Baseline and Week 52)