Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 307
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
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
- Single (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
- •Diagnosis of branch retinal vein occlusion in at least one eye
- •Visual acuity between 20/400 to 20/40
排除标准
- •Active eye infection
- •Ocular hypertension which is not controlled on monotherapy (one medication)
- •Anticipated need for eye surgery during the study
- •Cataract surgery in either eye within 3 months
- •Eye surgery including laser of any type within 6 months
- •Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
- •Use of ocular steroids within 3 months
- •Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study
研究组 & 干预措施
Ozurdex®
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
干预措施: dexamethasone intravitreal implant (Drug)
Lucentis®
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
干预措施: ranibizumab (Biological)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: Baseline, Month 12
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
次要结局
- Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)(Baseline, Month 12)
- Percentage of Patients With 15-or-More Letter Improvement in BCVA(Baseline, Month 12)
- Percentage of Patients With a 15-or-More Letter Decrease in BCVA(Baseline, Month 12)
- Time to BCVA Improvement of 15-or-More Letters(12 Months)
- Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure(12 Months)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)(Baseline, Month 12)