A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
研究概览
简要总结
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
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 CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
- •BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
- •Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
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;
- •Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- •CNV- conditions with a high likelihood of spontaneous resolution;
- •History of intravitreal treatment with steroids;
- •History of laser photocoagulation;
- •History of intraocular treatment with any anti-angiogenic drugs.
研究组 & 干预措施
Ranibizumab
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 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 could switch 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 to Month 2
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. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
次要结局
- Change From Baseline in BCVA in Study Eye up to Month 2(Baseline, Month 1, Month 2)
- 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)
- Change From Baseline in Central Subfield Volume (CSFV) in Study Eye(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline(Baseline, Month 2, Month 6, Month 12)
- Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline(Baseline, Month 2, Month 6, Month 12)
- Number of Participants With Presence of Active Chorioretinal Leakage(Baseline, Month 2, Month 6, Month 12)
- Number of Participants With Ranibizumab Treatments in Study Eye(Month 12)
- Average Change From Baseline in BCVA(Baseline (BL), Month 1 through Month 6, Month 1 through Month 12)
- 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 > 1, > 5, > 10 and > 15 Letters Loss(Month 2, Month 6, Month 12)
- Number of Participants With Requirement for Rescue Treatment at Month 1(Month 1)
- Number of Participants With Re-treatments(Month 12)
- Number of Primary Reasons for Decision to Treat by Investigator(Month 12)