NCT03452527终止2 期
A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Change in Choroidal Neovascularization (CNV) Over Time
研究概览
简要总结
The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet 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
- 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
- •Males or females of any race, ≥50 years of age
- •Active primary CNV secondary to AMD in the study eye
排除标准
- •Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
- •Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
- •Vitrectomy in the study eye
研究组 & 干预措施
ICON-1 maintenance therapy
Experimental
ICON-1 maintenance therapy after initial aflibercept treatment
干预措施: ICON-1 (Biological)
ICON-1 combination therapy
Experimental
ICON-1 combination therapy with aflibercept treatment
干预措施: aflibercept (Biological)
ICON-1 combination therapy
Experimental
ICON-1 combination therapy with aflibercept treatment
干预措施: ICON-1 (Biological)
ICON-1 maintenance therapy
Experimental
ICON-1 maintenance therapy after initial aflibercept treatment
干预措施: aflibercept (Biological)
结局指标
主要结局
Change in Choroidal Neovascularization (CNV) Over Time
时间窗: Month 9
Mean change from baseline in CNV area in the study eye
次要结局
- Change in Best Corrected Visual Acuity (BCVA) Over Time(Month 9)
研究者
研究点 (8)
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