A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of RBM-007 Monotherapy and RBM-007 in Combination With Eylea® Compared to Eylea® Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 8
- 主要终点
- Visual Acuity - Continuous
研究概览
简要总结
This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).
详细描述
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity
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
- 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.
- •Male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures.
- •Diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography.
- •Presence of macular edema or subretinal fluid.
- •Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye.
- •Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.
- •Visual acuity of 24 letters (20/320) or better in the fellow eye.
- •Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography
排除标准
- •Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
- •Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).
- •Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
- •Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study.
- •Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study.
- •Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6 mmHg) in the study eye.
- •Evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study
- •History of vitrectomy in the study eye.
- •Need for ocular surgery in the study eye during the course of the study.
- •YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.
- •Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.
研究组 & 干预措施
Sham + RBM-007
Sham + RBM-007 intravitreal injection
干预措施: RBM-007 Injectable Solution (Drug)
Sham + RBM-007
Sham + RBM-007 intravitreal injection
干预措施: Sham (Drug)
RBM-007 + Aflibercept
RBM-007 + Aflibercept intravitreal injection
干预措施: RBM-007 Injectable Solution (Drug)
RBM-007 + Aflibercept
RBM-007 + Aflibercept intravitreal injection
干预措施: Aflibercept (Drug)
Sham + Aflibercept
Sham + Aflibercept intravitreal injection
干预措施: Aflibercept (Drug)
Sham + Aflibercept
Sham + Aflibercept intravitreal injection
干预措施: Sham (Drug)
结局指标
主要结局
Visual Acuity - Continuous
时间窗: Week 16
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
次要结局
- Fibrosis Change(Week 16)
- Macular Thickness Change(Week 16)
- Safety - Ocular(Week 20)
- Visual Acuity - Categorical(Week 16)
- Macular Volume Change(Week 16)