NCT01846299已完成3 期
A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
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
- 181
- 试验地点
- 1
- 主要终点
- Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
研究概览
简要总结
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
- •BCVA must be between ≥ 24 and ≤ 83 letters;
- •Visual loss should be mainly due to the presence of any eligible types of ME.
排除标准
- •Women of child-bearing potential,
- •Active malignancies;
- •History of stroke less than 6 months prior to screening;
- •Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
- •Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- •Any type of advanced, severe or unstable ocular disease or its reatment;
- •ME with a high likelihood of spontaneous resolution.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Ranibizumab
Experimental
A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
干预措施: Ranibizumab (Drug)
Sham control
Sham Comparator
Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
干预措施: Sham control (Other)
结局指标
主要结局
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
时间窗: Baseline, Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
次要结局
- Average Change From Baseline in BCVA(Baseline (BL), month 1 through month 6, month 1 through month 12)
- Number of Participants Requiring Rescue Treatment at Month 1(Month 1)
- Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline(Month 2, Month 6, Month 12)
- Change From Baseline in Central Subfield Volume (CSFV) in Study Eye(Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Number of Participants With Re-treatments(Month 6, month 12)
- Change From Baseline in BCVA in Study Eye up to Month 2(Baseline, Month 1, Month 2)
- Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline(Month 2, Month 6, Month 12)
- Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Number of Participants With Presence of Active Macular Edema (ME) Leakage(Month 2)
- Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss(Month 2, Month 6, Month 12)
- Number of Primary Reasons for Decision to Treat by Investigator(12 months)
- Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters(Month 2, Month 6 , Month 12)
- Number of Participants With Ranibizumab Treatments(Month 12)
研究者
研究点 (1)
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