2025-524894-17-00招募中3 期
A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited106 个研究点 分布在 10 个国家目标入组 250 人开始时间: 2026年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 106
- 主要终点
- Mean change in best-corrected visual acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS]) letter score from baseline to Year 1
研究概览
简要总结
The primary objective is to demonstrate that EYE201/MK-8748 is non-inferior to aflibercept with respect to mean change in BCVA (ETDRS letters) from baseline to Year 1
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye)
- •The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment
- •Has a decrease in vision in the study eye that has been determined by the Investigator to be primarily the result of NVAMD
排除标准
- •Has uncontrolled blood pressure at screening
- •History of any prior macular laser photocoagulation in the study eye
- •History of uveitis in either eye
- •History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study
- •Has uncontrolled glaucoma in the study eye
- •Has active retinal disease other than the condition under investigation in the study eye
- •Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye
研究组 & 干预措施
AFLIBERCEPT
Comparator
干预措施: AFLIBERCEPT (Drug)
FLUORESCEIN
Auxiliary
干预措施: FLUORESCEIN (Drug)
结局指标
主要结局
Mean change in best-corrected visual acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS]) letter score from baseline to Year 1
Mean change in best-corrected visual acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS]) letter score from baseline to Year 1
次要结局
未报告次要终点
研究者
Loni Da Silva
Scientific
Eyebiotech Limited
研究点 (106)
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