A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 主要终点
- Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
研究概览
简要总结
This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
- •ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye
排除标准
- •Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
- •Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
- •CRVO disease duration > 9 months from date of diagnosis
- •Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
- •Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
研究组 & 干预措施
VEGF Trap-Eye
Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
干预措施: VEGF Trap-Eye 2.0mg (Biological)
Sham
Monthly Sham IVT injection until Week 24 Primary Endpoint
干预措施: Sham (Drug)
结局指标
主要结局
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
时间窗: Baseline and at Week 24
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
次要结局
- Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)(Baseline and at Week 24)
- Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF(Baseline and at Week 24)
- Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks(Baseline to Week 24)
- Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)(Baseline and at Week 24)