NCT00509795已完成3 期
A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,217
- 试验地点
- 188
- 主要终点
- Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
研究概览
简要总结
This study is a phase 3, 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 the US and Canada.
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 FA in the study eye.
- •Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) of: letter score of 73 to 25 (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. See Appendix J.4) 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, except dietary supplements or vitamins.
- •Any prior treatment with anti-VEGF agents in the study eye.
- •Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- •Subretinal hemorrhage 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 270 degrees by visible CNV.)
- •Scar or fibrosis, making up > 50% of total lesion in the study eye.
- •Scar, fibrosis, or atrophy involving the center of the fovea.
- •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.
- •History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either 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 its unlikely to interfere with the injection.
研究组 & 干预措施
aflibercept injection 2.0mg Q4
Experimental
干预措施: aflibercept injection (VEGF Trap-Eye, BAY86-5321) (Biological)
aflibercept injection 2.0mg Q8
Experimental
干预措施: aflibercept injection (VEGF Trap-Eye, BAY86-5321) (Biological)
aflibercept injection 0.5mg Q4
Experimental
干预措施: aflibercept injection (VEGF Trap-Eye, BAY86-5321) (Biological)
结局指标
主要结局
Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
时间窗: Baseline and at week 52
Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.
次要结局
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF(Baseline and 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 Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF(Baseline and at Week 52)
- Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.(Baseline and at week 52)
研究者
研究点 (188)
Loading locations...
相似试验
已完成
3 期
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)Macular DegenerationNCT00637377Bayer1,240
已完成
3 期
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)Macular Edema Secondary to Central Retinal Vein OcclusionNCT00943072Regeneron Pharmaceuticals189
已完成
2 期
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMDMacular DegenerationNCT00527423Regeneron Pharmaceuticals157
已完成
3 期
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)Retinal Vein OcclusionNCT01012973Bayer177
已完成
3 期
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)Macular EdemaNCT01512966Bayer73