A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual impairment due to choroidal neovascularization (CNV) secondary to PM
- •Best corrected visual acuity (BCVA) in the study eye > 24 and < 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
- •High myopia (> -6D), anterior-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia
- •Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal
排除标准
- •Patients with uncontrolled systemic or ocular diseases
- •Blood pressure > 150/90 mmHg
- •History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
- •Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ranibizumab driven by disease activity
Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
干预措施: Ranibizumab (Drug)
Ranibizumab driven by disease activity
Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
干预措施: Sham Ranibizumab (Drug)
Ranibizumab driven by disease activity
Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
干预措施: Sham verteporfin PDT (Drug)
Ranibizumab driven by stabilization criteria
Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
干预措施: Ranibizumab (Drug)
Ranibizumab driven by stabilization criteria
Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
干预措施: Sham Ranibizumab (Drug)
Ranibizumab driven by stabilization criteria
Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
干预措施: Sham verteporfin PDT (Drug)
Verteporfin PDT
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
干预措施: Ranibizumab (Drug)
Verteporfin PDT
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
干预措施: Verteporfin PDT (Drug)
Verteporfin PDT
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
干预措施: Sham Ranibizumab (Drug)
Verteporfin PDT
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
干预措施: Sham verteporfin PDT (Drug)
结局指标
主要结局
Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye
时间窗: Baseline, Month 1 through Month 3
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.
次要结局
- Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye(Baseline and Month 1 through Month 12)
- Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3(Month 3)
- Number of Ranibizumab Injections Received Prior to Month 3(Day 1 and prior to month 3)
- Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye(Baseline and Month 6)
- Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3(Month 3)
- Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period(Day 1 prior to month 6 and prior to month 12)
- Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12(Months 6 and 12)
- Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye(Baseline and Month 12)
- Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12(Months 6 and 12)
- Change From Baseline in Central Retinal Thickness of the Study Eye Over Time(Baseline, Month 3, Month 6 and Month 12)
- Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period(Month 3 up to month 12)