NCT01535950已完成2 期
A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 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
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time
研究概览
简要总结
This study will assess the safety and efficacy of LFG316 in patients with 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
- Single (Participant)
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
- •Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
- •An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
- •History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.
排除标准
- •History of recurrent non-response to anti-VEGF therapy in the study eye.
- •In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
- •Choroidal neovascularization due to a cause other than AMD.
- •In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
- •History of infectious uveitis or endophthalmitis in either eye.
- •Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.
- •Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye
研究组 & 干预措施
LFG316
Experimental
干预措施: LFG316 (Drug)
Sham
Sham Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time
时间窗: Day 1 to 113
Number or retreatments with anti-VEGF treatments will be recorded
次要结局
- Effect of LFG316 on visual acuity(Day 1 and 113)
- Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable(Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study))
- The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.(Day 1 and 113)
- Number of patients with adverse events(Day 113)
- Serum concentrations of total LFG316 versus time(Days 1, 8, 15, 29, 43, 57, 71, 85 and 113)
研究者
研究点 (1)
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