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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 108
- 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
研究组 & 干预措施
0.5 mg ranibizumab with 2.0 mg OPT-302
Experimental
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
干预措施: ranibizumab (Biological)
0.5 mg ranibizumab with sham
Sham Comparator
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
干预措施: sham intravitreal injection (Other)
0.5 mg ranibizumab with sham
Sham Comparator
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
干预措施: ranibizumab (Biological)
0.5 mg ranibizumab with 0.5 mg OPT-302
Experimental
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
干预措施: ranibizumab (Biological)
0.5 mg ranibizumab with 0.5 mg OPT-302
Experimental
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
干预措施: OPT-302 (Biological)
0.5 mg ranibizumab with 2.0 mg OPT-302
Experimental
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
干预措施: OPT-302 (Biological)
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 (108)
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