A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
研究概览
简要总结
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
详细描述
Patients attended 14 scheduled study visits during 12 months.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The reading center was masked for treatment assignment in order to ensure unbiased evaluation of the primary, secondary and exploratory objectives that were determined by SDOCT, autofluorescence imaging, and microperimetry and multifocal ERG (where available).
When communicating with the reading center study centers had to be vigilant not to unblind the reading center to the treatment.
Site staff performing the assessments of BCVA, contrast sensitivity (where possible), VFQ25 and IReST (reading speed) were also masked to the identity of the treatment.
The central laboratory used for analysis of all specimens collected for biomarker assessment were blinded to the identity of the treatment.
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
- •Visual impairment predominantly due to neovascular AMD Active
- •Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion
排除标准
- •Stroke or myocardial infarction less than 3 Months prior to study entry
- •Active injection or inflammation of either eye at the time of study entry
- •Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
研究组 & 干预措施
Ranibizumab
1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
干预措施: Ranibizumab (Drug)
Aflibercept
1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months
干预措施: Aflibercept (Drug)
结局指标
主要结局
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
时间窗: Month 3, Month 4, Month 5, Month 6
The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.
次要结局
- Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12(Month 12)
- IREST at Month 12(Month 12)
- National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12(Month 12)
- Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)(Month 3 to Month 6, Month 12)