NCT01976338已完成3 期
A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Branch Retinal Vein Occlusion (BRVO) [Blossom]
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
- 283
- 试验地点
- 1
- 主要终点
- Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6
研究概览
简要总结
Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to 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
- Double (Participant, 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
- •Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.
排除标准
- •Pregnant or nursing women or women of child bearing potential without unless using an effective contraception
- •Stroke or myocard infarction within 3 months prior to study
- •History of malignancy within the past 5 years
- •Uncontrolled hypertension
- •Active infection or inflammation in any eye
- •use of corticosteroids for at least 30 days in the last 6 months
- •treatment with anti-angiogenic drugs in any eye within last 3 months
- •Panretinal or focal/drid laser photocoagulation within the last few months
研究组 & 干预措施
Ranibizumab 0.5 mg
Experimental
PRN Intravitreal injection
干预措施: Ranibizumab 0.5 mg (Drug)
Sham injection
Sham Comparator
As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
干预措施: Sham injection (Other)
结局指标
主要结局
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6
时间窗: Baseline to Month 1 through Month 6
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.
次要结局
- Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12(Baseline to Month 1 through Month 12)
- Best Corrected Visual Acuity (BCVA) Change Over Time(Month 1 through Month 12)
- Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time(Baseline to month 12)
- Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye(Baseline to 12 months)
- Change in Central-Sub-Field- Thickness (CSFT) Over Time(Month 1 to month 12)
- Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time(month 3, 6 and 12)
- Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time(Months 3, 6 and 12)
- Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time(Months 3, 6 and 12)
- Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12(Baseline, months 3, 6 and 12)
研究者
研究点 (1)
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