Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 287
- 主要终点
- Change in BCVA as Measured by the ETDRS Letter Score
研究概览
简要总结
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
详细描述
The T&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.
To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T&E regimen with intravitreal aflibercept in subjects with nAMD.
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
- None
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
- •Men and women ≥ 50 years of age.
- •Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
- •ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
- •The area of CNV must occupy at least 50% of the total lesion.
排除标准
- •Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
- •Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
- •Prior treatment with anti-VEGF agents as follows:
- •Prior treatment with anti-VEGF therapy in the study eye is not allowed
- •Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
- •Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
- •Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- •Subretinal hemorrhages that are 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.
研究组 & 干预措施
Early-start T&E / Arm 1
Early-start T&E arm: test group, early treatment individualization
干预措施: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
Late-start T&E / Arm 2
Late-start T&E arm; per label, control group, treatment individualization after Year 1
干预措施: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Change in BCVA as Measured by the ETDRS Letter Score
时间窗: From Week 16 to Week 104
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
次要结局
- Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline(at Week 104)
- Change in Central Retinal Thickness (CRT)(From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104)
- Duration of Last Treatment Interval(Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination)
- Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval(at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks)
- Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104(At Week 52 and Week 104)
- Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52(from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52)
- Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline(At week 52)
- Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline(At Week 52 and Week 104)