A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 73
- 主要终点
- Change From Baseline in BCVA (Best Corrected Visual Acuity) 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
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects 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
- •Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- •Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye
- •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
- •Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
- •More than 2 previous macular laser treatments in the study eye
- •Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
- •Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
- •Active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
- •Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
- •Only 1 functional eye even if that eye is otherwise eligible for the study
研究组 & 干预措施
Intravitreal Aflibercept Injection 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
干预措施: VEGF Trap-Eye (BAY86-5321) (Biological)
Intravitreal Aflibercept Injection 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
干预措施: VEGF Trap-Eye (BAY86-5321) (Biological)
Macular Laser Photocoagulation (Control)
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
干预措施: Macular Laser Photocoagulation (Control) (Procedure)
结局指标
主要结局
Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
时间窗: Baseline up to Week 52
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
次要结局
- 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 up to 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 up to Week 52)
- 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 up to Week 52)
- Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF(Baseline up to 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 up to 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 up to Week 52)