NCT04640272已完成2 期
A Multi-Center, Open Label, TOFU Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Visual Acuity - Continuous
研究概览
简要总结
This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- •Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures.
- •Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
- •Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline.
- •Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
- •Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.
- •BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.
- •Reasonably clear media and some fixation in the study eye to allow for good quality SD-OCT and fundus photography.
排除标准
- •Subjects whose vision have improved >15 BCVA letters at exit visit of previous study over its baseline
- •Subjects who experienced any drug related serious adverse event during previous study
研究组 & 干预措施
RBM-007 injectable solution
Experimental
intravitreal injection
干预措施: RBM-007 (Drug)
结局指标
主要结局
Visual Acuity - Continuous
时间窗: Month 4
Mean change in Best Corrected Visual Acuity from Baseline
次要结局
- Visual Acuity - Categorical(Month 4)
- Change From Baseline in Central Macular Subfield Thickness(Month 4)
研究者
研究点 (6)
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