A Multiple Dose, Two-cohort Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous LFG316 in Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)
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
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active choroidal neovascular AMD in at least one eye.
排除标准
- •Retinal disease other than AMD that, in the investigator's opinion, would interfere with safety or study conduct.
- •Choroidal neovascularization due to a cause other than AMD.
- •In the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct.
- •Any disease or concomitant (or recent) medication expected to cause systemic immunosuppression.
- •History of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis.
- •History of hospitalization for pneumococcal pneumonia within the past 3 years.
- •History of serious systemic infection within the past 12 months.
- •Any of the following treatments to the study eye within 7 days prior to study drug dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
LFG316: 10 mg/kg (2 doses in cohort 1)
干预措施: LFG316 (Drug)
LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).
干预措施: LFG316 (Drug)
结局指标
主要结局
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
时间窗: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Number of retreatments with anti-VEGF treatments will be recorded.
Number and percentage of patients with adverse events.
时间窗: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Adverse events will be determined based on descriptive analyses of vital signs, ECG evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.Will be tabulated by body system and preferred term with a breakdown by treatment.
次要结局
- Effect of LFG316 on visual acuity(Day 1 to Day 113)
- Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.(Day 1 to Day 113)
- Serum concentrations of total LFG316 versus time(Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.)
- Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time(screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).)