2024-512879-13-00已完成3 期
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 Neovascular Age-related Macular Degeneration (nAMD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 39
- 主要终点
- Mean change from Baseline to Week 52 in ETDRS BCVA letters
研究概览
简要总结
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 AMD.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female participants at least 50 years of age.
- •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, in the investigator's opinion, interfere with assessment of BCVA, assessment of safety, or fundus imaging.
结局指标
主要结局
Mean change from Baseline to Week 52 in ETDRS BCVA letters
Mean change from Baseline to Week 52 in ETDRS BCVA letters
次要结局
- Efficacy: - Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52 - Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52
- - Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52 - Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52
研究者
Clinical Trial Information
Scientific
Opthea Limited
研究点 (39)
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