Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,011
- 试验地点
- 235
- 主要终点
- Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
研究概览
简要总结
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
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)
盲法说明
Up to Week 108: Participant and Investigator masked. Week 108 to Week 156: Participant and Investigator unmasked to treatment intervals.
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
- •Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
- •Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
- •BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
- •Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
- •Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
- •Other protocol-specified inclusion criteria.
- •Additional inclusion criteria for Year 3:
- •At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
- •Participant is enrolled at a site that participates in the extension period.
排除标准
- •Causes of CNV other than nAMD in the study eye.
- •Scar, fibrosis, or atrophy involving the central subfield in the study eye.
- •Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
- •Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
- •History of idiopathic or autoimmune uveitis in the study eye.
- •Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
- •History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
- •Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
- •Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
- •Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
- •Other protocol-specified exclusion criteria
研究组 & 干预措施
Aflibercept 2q8
In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)
干预措施: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) (Drug)
Aflibercept 2q8
In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)
干预措施: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) (Drug)
Aflibercept HDq12
Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
干预措施: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) (Drug)
Aflibercept HDq16
Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
干预措施: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) (Drug)
结局指标
主要结局
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
时间窗: At baseline and Week 48
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
次要结局
- Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60(At baseline and Week 60)
- Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16(At Week 16)
- Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48(At baseline and Week 48)
- Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48(At Week 48)
- Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48(At baseline and Week 48)
- Change in Total Lesion Area From Baseline to Week 48(At baseline and Week 48)
- Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48(At Week 48)
- Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48(At baseline and Week 48)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48(At baseline and Week 48)
- Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48(Up to Week 48)
- Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response(Up to week 96)