NCT05637255已完成2 期
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
Sylentis, S.A.17 个研究点 分布在 3 个国家目标入组 99 人开始时间: 2022年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 17
- 主要终点
- Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
研究概览
简要总结
The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Active subfoveal or juxtafoveal choroidal neovascularization secondary to AMD
- •Best Corrected Visual Acuity (BCVA) between 70-25 letters (ETDRS) at Screening
- •Intraretinal or subretinal fluid
- •Central Subfield Thickness > 300 µm
排除标准
- •Pregnant or breastfeeding females or those with a positive pregnancy test.
- •Females of childbearing potential who will not use a medically acceptable contraceptive method
- •Current, previous chronic or recurrent condition according to the investigator's judgement.
- •Concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications
- •Concurrent disease in the study eye
- •Previous treatment with systemic anti-Vascular Endothelial Growing Factor (Anti-VEGF) drugs or pro-VEGF treatments
- •Concurrent disease in the study eye, other than AMD
研究组 & 干预措施
SYL1801 ophthalmic solution Low Dose once daily
Experimental
42 treatment days
干预措施: SYL1801 (Drug)
SYL1801 ophthalmic solution Middle Dose once daily
Experimental
42 treatment days
干预措施: SYL1801 (Drug)
SYL1801 ophthalmic solution High Dose once daily
Experimental
42 treatment days
干预措施: SYL1801 (Drug)
结局指标
主要结局
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
时间窗: 42 days after first administration
ETDRS chart
次要结局
- Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level(42 days after first administration)
- Change from Baseline on intraocular pressure (IOP)(42 days after first administration)
- Proportion of subjects within each cohort who needed rescue medication at any point of the study(Through study completion, up to 42 days)
- Change from Screening on leakage area on Day 42 after last instillation of the assigned(43 days after first administration)
- Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level(Through study completion, up to 42 days)
- Change from Baseline on flow area on Day 42 after last instillation of the assigned(42 days after first administration)
- Adverse Event Evaluation(Through study completion, up to 42 days)
研究者
研究点 (17)
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