2024-517545-13-00招募中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 (CONSTANCE)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 24
- 主要终点
- Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters
研究概览
简要总结
To evaluate the efficacy of intravitreal (IVT) injections of faricimab in the study eye following the regimen in each of the treatment arms as change from baseline in best corrected visual acuity (BCVA) averaged over Weeks 44, 48, and 52
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase Iiib/iv Open Label Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥50 years at the time of signing Informed Consent Form
- •Overtly healthy as determined by medical evaluation that includes medical history and physical examination.
- •Agreement to adhere to the contraception requirements described
- •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 OCT.
- •Ocular Inclusion Criteria for Study Eye: 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).
- •Ocular Inclusion Criteria for Study Eye:Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
排除标准
- •Macular neovascularization due to causes other than AMD, 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 will be excluded from study entry
- •Ocular Exclusion for Both Eyes Potential participants are excluded from the study if any of the following criteria apply: – 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
结局指标
主要结局
Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters
Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters
次要结局
- Change from baseline in BCVA averaged over Weeks 92, 96, and 100
- Change from baseline in BCVA over time
- Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52
- Change from baseline in CST averaged over Weeks 92, 96, and 100
- Change from baseline in CST over time
- Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100
- Incidence and severity of ocular adverse events
- Incidence and severity of non-ocular adverse events
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (24)
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