NCT07516132招募中3 期
A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 8
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144
研究概览
简要总结
Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96
- •Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging
- •Are able and willing to comply with all study requirements and visits
- •Have provided written informed consent
排除标准
- •Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1
- •History of intraocular inflammation in the study eye
- •Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular
- •Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results
- •Female participants who are pregnant (had a positive urine test at the Baseline visit [Day 1]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144
时间窗: from Baseline (Day 1) through Week 144
Number of events
Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144
时间窗: from Baseline (Day 1) through Week 144
Percentage
次要结局
未报告次要终点
研究者
研究点 (8)
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