Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 62
- 主要终点
- Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8
研究概览
简要总结
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
- •Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
- •Study eye must:
- •Have active leakage on Fluorescein Angiogram involving the fovea
- •Have edema involving the fovea
- •Be free of scarring, fibrosis, or atrophy involving the central foveal zone
排除标准
- •Previous subfoveal focal laser photocoagulation in the study eye
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
- •Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
- •Active intraocular inflammation (grade trace or above) in the study eye
- •Current vitreous hemorrhage in the study eye
- •Polypoidal choroidal vasculopathy (PCV) in the study eye
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
- •Premenopausal women not using adequate contraception
- •Current treatment for active systemic infection
- •Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment
研究组 & 干预措施
ONS-5010 bevacizumab
干预措施: bevacizumab (Biological)
ranibizumab
干预措施: ranibizumab (Biological)
结局指标
主要结局
Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8
时间窗: Baseline, 8 weeks
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Evaluate the Effectiveness of Intravitreal Injections of ONS-5010 Compared to Ranibizumab in Preventing Vision Loss, as Measured by the Mean Change in Baseline Best Correct Visual Acuity (BCVA) at Week 8
时间窗: Baseline, 8 weeks
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
次要结局
未报告次要终点