NCT07587515招募中1 期
Open-Label, Multiple Ascending Dose Phase 1b/2a Study of the Safety and Tolerability of Intravitreal (IVT) EYC-0305 in Patients With Neovascular Age-Related Macular Degeneration
Eyconis INC.6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月19日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 6
研究概览
简要总结
This Phase 1b/2a study will primarily investigate the safety and tolerability of EYC-0305 delivered by intravitreal (IVT) injection every 24 weeks in patients with neovascular (wet) age-related macular degeneration (AMD). The pharmacokinetics (PK) and immunogenicity of EYC-0305, and the effect on disease activity and vision will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Men or women 50 years and older with neovascular (wet) AMD meeting all study-specified eligibility criteria
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Known hypersensitivity or known allergy that would preclude study drug administration
- •Inability to obtain ophthalmic imaging, eg, due to media opacity, inadequate pupillary dilation, allergy to fluorescein dye or lack of venous access
- •Uncontrolled diabetes mellitus
- •History of cerebrovascular accident (CVA) or myocardial infarction within 180 days of the Day 1 visit
- •Renal failure, dialysis, or history of renal transplant
- •Concurrent psychiatric or medical condition that in the opinion of the Investigator will interfere with study participation or completion
- •Pregnant or breastfeeding women
研究组 & 干预措施
EYC-0305 Dose Level 2
Experimental
干预措施: EYC-0305 (Biological)
EYC-0305 Dose Level 1
Experimental
干预措施: EYC-0305 (Biological)
EYC-0305 Dose Level 3
Experimental
干预措施: EYC-0305 (Biological)
EYC-0305 Dose Level 4
Experimental
干预措施: EYC-0305 (Biological)
研究者
研究点 (6)
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