NCT01377597已完成3 期
A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
研究概览
简要总结
The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
- •Best-corrected visual acuity (BCVA):
- •CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
- •BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2
排除标准
- •Pregnant or nursing women
- •History of stroke
- •Uncontrolled blood pressure
- •Active ocular infection or intraocular inflammation in either eye
- •Uncontrolled glaucoma in either eye
- •Neovascularization of the iris or neovascular glaucoma in either eye
- •Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
- •Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
- •Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
- •Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
- •Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
- •Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
- •Use of any intra-ocular corticosteroid implants in the study eye
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ranibizumab intravitreal injection
Experimental
干预措施: ranibizumab (Drug)
结局指标
主要结局
Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
时间窗: 3 months
次要结局
- Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3(3 months)
- Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3(3 months)
- Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit(3 months)
- Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3(3 months)
- Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events(3 months)
研究者
研究点 (1)
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