A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Change in central retinal thickness (CRT)
研究概览
简要总结
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)
详细描述
This study is a double-blind, parallel, multicenter-phase 2a study to evaluate the safety and efficacy of EB-203 in patients with nAMD.
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Final subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio into Group A(EB-203 2%, 4 times a day) and Group B (EB-203 4%, 4 times a day).
Randomization will be performed using the study institution (hereinafter "institution") as a stratification factor.
Subjects will receive the investigational products according to the group to which they are randomized.
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
- Double (Participant, 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
- •Adults aged 50 years or older
- •Subjects with a best corrected visual acuity (BCVA) score between 25 and 73, measured by the Early Treatment of Diabetic Retinopathy Study(ETDRS) chart, at a distance of 4 m during the screening (equivalent to 20/40 to 20/320 in the Snellen chart)
- •Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study
排除标准
- •Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)
- •Subjects who have received ocular or systemic treatment, such as photodynamic therapy (PDT) or laser photocoagulation, or have undergone a surgical operation for nAMD (however, health functional foods, vitamin supplements, etc., are excluded)
- •Subjects whose study eye has been treated with anti-vascular endothelial growth factor (anti-VEGF) drugs (e.g. ranibizumab, bevacizumab, aflibercept, etc.) or a combination therapy for the treatment of nAMD prior to screening
- •Subjects who have received intravitreal treatment using steroids
- •Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area
- •Subjects with vitreous hemorrhage in the study eye
- •Subjects who have undergone vitrectomy
- •Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment
- •Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
- •Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
研究组 & 干预措施
Group A
EB-203 2% QID
干预措施: EB-203 (Drug)
Group B
EB-203 4% QID
干预措施: EB-203 (Drug)
结局指标
主要结局
Change in central retinal thickness (CRT)
时间窗: Week 12
Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline.
次要结局
- Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid(Weeks 4, 8, 12)
- Change in BCVA(Weeks 4, 8, 12)
- Change Proportion (%) in BCVA(Weeks 4, 8, 12)
- Proportion (%) of subjects who received rescue medication(Weeks 4, 8, 12)