A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 主要终点
- Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
研究概览
简要总结
This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
详细描述
Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up
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
- Quadruple (Participant, Care Provider, 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
- •Patients with clinically significant DME with central involvement
- •Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
- •ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
排除标准
- •History of vitreoretinal surgery in the study eye
- •Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
- •Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
- •Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
- •Ocular disorders in the study eye, other than DME, that may confound interpretation of study results
研究组 & 干预措施
Intravitreal Aflibercept Injection .5Q4
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
干预措施: Intravitreal Aflibercept Injection (Drug)
Intravitreal Aflibercept Injection 2Q4
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
干预措施: Intravitreal Aflibercept Injection (Drug)
Intravitreal Aflibercept Injection 2Q8
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
干预措施: Intravitreal Aflibercept Injection (Drug)
Intravitreal Aflibercept Injection 2PRN
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
干预措施: Intravitreal Aflibercept Injection (Drug)
Laser Photocoagulation
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
干预措施: Laser Photocoagulation (Procedure)
结局指标
主要结局
Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
时间窗: At week 24
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
次要结局
- Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF(At week 24 and week 52)
- Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF(At week 24 and week 52)
- Number of Focal Laser Treatments(Week 1 to week 48)
- Change in BCVA From Baseline to Week 52 - LOCF(At week 52)