A Phase IIIb, Open-label, Multi-center 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of Ranibizumab (0.3 mg and/or 0.5 mg) in Patients With Subfoveal Choroidal Neovasculariza-tion Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 531
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
研究概览
简要总结
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 50 years of age
- •Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
- •The total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area
- •The total lesion area must be <= 12 disc areas
- •Patients who have a BCVA (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic Retinopathy Study) grading charts (approximately 20/40 to 20/320)
排除标准
- •Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
- •Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1
- •Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Ranibizumab
Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on re-treatment criteria described in the protocol. For patients who had participated in the ANCHOR study, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met re-treatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
时间窗: Baseline through end of study (12 month treatment period)
Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.
Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye
时间窗: Baseline through end of study (12 month treatment period)
Grade 3 targeted AEs included: * 4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days * ≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection * sustained (\>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a \>20 mm Hg change in IOP persisting longer than 14 days * new retinal tear or detachment involving the macula * new vitreous hemorrhage \>2+ severity not resolving within 14 days * new or increase of previous retinal hemorrhage \>1 disc area in size and involving the fovea
次要结局
- Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3(Baseline and Month 3)
- Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12(Baseline and Month 12)
- Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3(Baseline and Month 3)
- Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12(Baseline and Month 12)
- Time to the First Retreatment After Month 2(Month 2 to Month 11)
- Total Number of Treatments(Baseline (Month 0) to Month 11)