A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline
研究概览
简要总结
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with visual impairment due to macular edema following BRVO
- •Diagnosis of BRVO at maximum 6 months prior to Screening
- •BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
排除标准
- •Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
- •Central retinal thickness (CRT) < 250 µm in the study eye
- •Prior episode of RVO in the study eye
- •Active formation of new vessels in the study eye
- •Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
- •IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
- •Improvement of > 10 letters on BCVA between Screening and Baseline
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
干预措施: Ranibizumab (Drug)
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
干预措施: Dexamethasone Implant (Other)
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
干预措施: Sham injection (Other)
结局指标
主要结局
Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline
时间窗: Baseline, month 6
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6
次要结局
- Rate of the Internal Ocular Pressure (IOP)(Baseline, month 6)
- Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment(Baseline, 6 month)
- Time to Achieve a Significant Improvement ≥ 15 Letters(Baseline, month 6)
- Change Over Time in BCVA(baseline, month 6)
- Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires(Baseline, month 6)
- Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6(Baseline, month 6)
- Change Over Time of the Central Retinal Thickness (CRT)(Baseline, month 6)
- Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires(Baseline, month 6)
- Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires(Baseline, month 6)