NCT06795048进行中（未招募）4 期
A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 274
- 试验地点
- 67
- 主要终点
- Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
研究概览
简要总结
This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.
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
- •Overtly healthy as determined by medical evaluation that includes medical history and physical examination
- •Agreement to adhere to the contraception requirements described in the protocol
- •Ocular Inclusion Criteria for Study Eye:
- •Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
- •BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study [ETDRS] protocol and addressed at the initial testing distance of 4 meters on Day 1)
- •Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
排除标准
- •Ocular Exclusion Criteria for Study Eye:
- •MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
- •Retinal pigment epithelial tear involving the macula on Day 1
- •Current vitreous hemorrhage on Day 1
- •Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor [VEGF], or complement inhibitor medication) for other retinal diseases
- •Ocular Exclusion Criteria for Fellow (Non-Study) Eye:
- •Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits
- •Ocular Exclusion for Both Eyes:
- •History of idiopathic or autoimmune associated uveitis in either eye
- •Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1
研究组 & 干预措施
Arm A: Faricimab Early Treat & Extend Regimen
Experimental
干预措施: Faricimab (Drug)
Arm B: Faricimab Modified Treat & Extend Regimen
Experimental
干预措施: Faricimab (Drug)
结局指标
主要结局
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
时间窗: Baseline and average of Weeks 44, 48, and 52
次要结局
- Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100(Baseline and average of Weeks 92, 96, and 100)
- Incidence and Severity of Non-Ocular Adverse Events(From first study treatment to Week 100)
- Change from Baseline in BCVA Score Over Time(From Baseline to Week 100)
- Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time(From Baseline to Week 100)
- Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time(From Baseline to Week 100)
- Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time(From Baseline to Week 100)
- Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52(Baseline and average of Weeks 44, 48, and 52)
- Change from Baseline in CST Averaged Over Weeks 92, 96, and 100(Baseline and average of Weeks 92, 96, and 100)
- Change from Baseline in CST Over Time(From Baseline to Week 100)
- Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100(Weeks 52 and 100)
- Incidence and Severity of Ocular Adverse Events(From first study treatment to Week 100)
研究者
研究点 (67)
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