Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 243
- 主要终点
- Injection Free Interval
研究概览
简要总结
The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
- •Visual Acuity between 20/40 and 20/400 in the study eye
排除标准
- •Any intraocular surgery within 3 months
- •High eye pressure
- •Uncontrolled systemic disease
研究组 & 干预措施
sham and ranibizumab
Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
干预措施: ranibizumab (Biological)
dexamethasone and ranibizumab
Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
干预措施: dexamethasone (Drug)
dexamethasone and ranibizumab
Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
干预措施: ranibizumab (Biological)
sham and ranibizumab
Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
干预措施: sham (Other)
结局指标
主要结局
Injection Free Interval
时间窗: Week 1 to Week 25
The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
次要结局
- Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25(Baseline, Week 25)
- Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye(Baseline, Week 25)
- Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye(Screening (-Week 28), Week 25)