NCT07064759招募中3 期
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 95
- 主要终点
- Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52
研究概览
简要总结
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
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
- •≥50 years of age at time of consent
- •MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
- •Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
- •Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
- •Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center
- •Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
- •BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
- •CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center
排除标准
- •Ocular Conditions:
- •MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)
- •History of retinal detachment in the study eye
- •History of or presence of active inflammation in either eye
- •Glaucoma or intraocular hypertension requiring more than 2 topical medications for control
- •Ocular Treatments/Interventions:
- •Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye
- •Systemic Conditions and Considerations:
- •Major illness or major surgical procedure in the 28 days prior to the Screening Visit
- •Uncontrolled blood pressure
- •Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
- •History of autoimmune condition that may predispose to the development of uveitis
研究组 & 干预措施
4D-150 IVT (3E10 vg/eye)
Experimental
干预措施: 4D-150 IVT (3E10 vg/eye) (Biological)
Aflibercept (AFLB) 2 mg IVT
Active Comparator
干预措施: EYLEA® (aflibercept) Injection 2 mg (0.05mL) (Biological)
结局指标
主要结局
Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52
时间窗: 52 Weeks
次要结局
- Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104(104 Weeks)
- Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104(104 Weeks)
- Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm(104 Weeks)
- Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104(104 Weeks)
- Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104(104 Weeks)
- Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104(104 Weeks)
- Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm(104 Weeks)
- Mean change from baseline in Central Subfield Thickness (CST) over time through Weeks 52 and 104(104 Weeks)
- Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104(104 Weeks)
研究者
研究点 (95)
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