NCT03345082已完成2 期
A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 110
- 主要终点
- Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)
研究概览
简要总结
A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.
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
- Quadruple (Participant, Care Provider, 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 subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
- •An ETDRS BCVA score between 60 and 25 (inclusive) letters
排除标准
- •Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
- •Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
- •Poorly controlled diabetes mellitus (defined as HbA1c>7%)
- •Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study
结局指标
主要结局
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)
时间窗: Baseline to Week 24
次要结局
- Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)(Baseline to Week 24)
- Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)(Baseline to Week 24)
- Proportion of participants gaining 15 or more ETDRS BCVA letters(Baseline to Week 24)
- Area under the ETDRS BCVA over time curve(Baseline to Week 24)
- Change in intra-retinal fluid and sub-retinal fluid on SD-OCT(Baseline to Week 24)
研究者
研究点 (110)
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