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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 71
- 主要终点
- Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1
研究概览
简要总结
Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD).
Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD.
The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.
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
- Triple (Participant, Care Provider, Investigator)
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
- •The main inclusion criteria include but are not limited to the following:
- •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
排除标准
- •include but are not limited to the following
- •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
- •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
Tiespectus Low Dose
Participants receive 3 initial administrations of tiespectus low dose every 4 weeks (Q4W), then continue to receive tiespectus low dose every 8weeks (Q8W) until week 48. After week48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92.
干预措施: Tiespectus (Drug)
Aflibercept 2 mg
Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
干预措施: Aflibercept (Drug)
Tiespectus High Dose
Participants receive 3 initial administrations of tiespectus high dose Q4W, then continue to receive tiespectus high dose Q8W until week48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92
干预措施: Tiespectus (Drug)
结局指标
主要结局
Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1
时间窗: Baseline and Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to Year 1 will be assessed.
次要结局
- Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1(Up to Year 1)
- Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1(Year 1)
- Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1(Year 1)
- Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1(Year 1)
- Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1(Year 1)
- Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1(Year 1)
- Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1(Year 1)
- Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1(Baseline and Year 1)
- Number of Participants who Experience One or More Systemic Adverse Events (AEs)(Up to approximately 96 weeks)
- Number of Participants who Experience One or More Ocular AEs(Up to approximately 96 weeks)