A 24-month, Phase IIIb, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline
研究概览
简要总结
The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female patients ≥ 18 years of age
- •Diagnosis of visual impairment exclusively due to ME secondary to CRVO
- •BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400)
排除标准
- •Uncontrolled blood pressure defined as systolic value of > 160 mm Hg or diastolic value of > 100 mm Hg at Screening or Baseline.
- •Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- •Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
- •Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
研究组 & 干预措施
Ranibizumab arm
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
干预措施: Ranibizumab 0.5 mg/0.05 ml (Drug)
结局指标
主要结局
Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline
时间窗: Baseline to month 12
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
次要结局
- Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline(Baseline to Month 24)
- Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24(Baseline and Month 1 to 12 or Month 24)
- Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24(Month 12 and Month 24)
- Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline(Baseline, Month 12 and Month 24)
- Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24(Month 12 and Month 24)
- Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye(Month 12 and Month 24)
- Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline(Month 12 and Month 24)