jRCT2073240017招募中不适用
[M23-409] A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AbbVie GK
- 入组人数
- 14
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 50age old over 至 89age old under（—）
- 性别
- All
入选标准
- •Age >= 50 years and <= 89 years
- •An ETDRS BCVA letter score between 78 and 40 in the study eye
- •Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
- •Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
- •Willing and able to provide written, signed informed consent for this study
- •Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
排除标准
- •CNV or macular edema in the study eye secondary to any causes other than AMD
- •Subfoveal fibrosis or atrophy in the study eye
- •Any condition in the investigator's opinion that could limit VA improvement in the study eye
- •Active or history of retinal detachment or current retinal tear in the study eye
- •Advanced glaucoma or history of secondary glaucoma in the study eye
- •Myocardial infarction, cerebrovascular accident, or transient ischemic attach within the past 6 months.
- •History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1
- •History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit
- •Prior treatment with gene therapy.
结局指标
主要结局
-
Mean change from baseline in Best Corrected Visual Acuity (BCVA) [Time Frame: At Week 54]
次要结局
未报告次要终点
研究者
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