NCT04989699已完成1 期
A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
详细描述
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
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
- Triple (Participant, Care Provider, Investigator)
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
- •Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
- •The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
- •Must have received at least 3 anti-VEGF injections in the past year.
- •Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
- •BCVA ETDRS score between 24 and 83 letters (~20/25 to ~20/320 Snellen equivalent)
排除标准
- •Have evidence of a scar, fibrosis or atrophy of >50% of the total lesion in the study eye
- •Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
- •Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
研究组 & 干预措施
OTX-TKI
Active Comparator
干预措施: OTX-TKI/Sham (Drug)
Aflibercept
Active Comparator
干预措施: Aflibercept/Sham (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Through study completion, an average of 1 year
Incidence and severity of treatment emergent adverse events
次要结局
- BCVA changes(Through study completion, an average of 1 year)
- Central subfield thickness changes(Through study completion, an average of 1 year)
- Rescue Therapy(Through study completion, an average of 1 year)
- Absence of Fluid(Through study completion, an average of 1 year)
- Number of injections(Through study completion, an average of 1 year)
研究者
研究点 (1)
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