A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,240
- 主要终点
- Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
研究概览
简要总结
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
详细描述
Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Men and women >/=50 years of age.
- •Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA) in the study eye.
- •ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters.
- •Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- •Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
排除标准
- •Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
- •Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
- •Any prior treatment with anti-VEGF agents in the study eye.
- •Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
- •Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
- •Scar or fibrosis making up >50% of the total lesion in the study eye.
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- •Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- •History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
- •Presence of other causes of CNV in the study eye.
- •Prior vitrectomy in the study eye.
- •History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- •Any history of macular hole of stage 2 and above in the study eye.
- •Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
- •History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
研究组 & 干预措施
Ranibizumab 0.5mg Q4
Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
干预措施: Ranibizumab (Drug)
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
干预措施: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) (Biological)
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
干预措施: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) (Biological)
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
干预措施: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) (Biological)
结局指标
主要结局
Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
时间窗: At week 52
Maintenance of vision was defined as a loss of \< 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
次要结局
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF(Baseline and at week 52)
- Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF(At week 52)
- Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF(Baseline and at week 52)
- Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF(Baseline and at week 52)