NCT03834753已完成3 期
A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 51
- 主要终点
- Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
研究概览
简要总结
This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
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
- Double (Participant, 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 25-67 letters read (20/50 to 20/320 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 haemorrhage 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
bevacizumab
Experimental
ONS-5010
干预措施: bevacizumab (Biological)
ranibizumab
Active Comparator
干预措施: ranibizumab (Biological)
结局指标
主要结局
Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
时间窗: Baseline, 11 months
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.
Proportion of Subjects Who Gain 15 or More Letters in Best Corrected Visual Acuity (BCVA)
时间窗: 11 months
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
- Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse(Baseline, 11 months)
- Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities(11 months, 12 months)
- Mean change in the best corrected visual acuity(Baseline, monthly to 11 months)
- Proportion of participants who gain at least 10 letters in the best corrected visual acuity(Baseline, 11 months)
- Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity(Baseline, 11 months)
- Proportion of participants who gain at least 5 letters in the best corrected visual acuity(Baseline, 11 months)
- Mean Change in the Best Corrected Visual Acuity(11 months)
- Proportion of Participants Who Gain at Least 10 Letters in the Best Corrected Visual Acuity(11 months)
- Proportion of Participants Who Gain at Least 5 Letters in the Best Corrected Visual Acuity(11 months)
- Proportion of Participants Who Lose Fewer Than 15 Letters in the Best Corrected Visual Acuity(11 months)
- Proportion of Participants With Visual-acuity Snellen Equivalent of 20/200 or Worse(11 months)
研究者
研究点 (51)
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