A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 986
- 试验地点
- 4
- 主要终点
- Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
研究概览
简要总结
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
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 CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
- •An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
排除标准
- •Any previous treatment for neovascular AMD.
- •Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
- •Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
- •additional inclusion/exclusion criteria may apply
研究组 & 干预措施
0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
干预措施: 2.0 mg OPT-302 (Biological)
0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
干预措施: 0.5 mg ranibizumab (Biological)
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
干预措施: 2.0 mg OPT-302 (Biological)
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
干预措施: 0.5 mg ranibizumab (Biological)
0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals.
干预措施: 0.5 mg ranibizumab (Biological)
0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals.
干预措施: Sham (Procedure)
结局指标
主要结局
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
时间窗: Baseline to Week 52
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)
次要结局
- Participants Gaining 15 or More ETDRS BCVA Letters(Baseline to Week 52)
- Participants Gaining 10 More ETDRS BCVA Letters(Baseline to Week 52)
- Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)(Baseline to Week 52)
- Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT(at Week 52)