NCT06223958进行中（未招募）3 期
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 344
- 试验地点
- 105
- 主要终点
- Best corrected visual acuity (BCVA)
研究概览
简要总结
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) 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
- 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
- •Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.
- •Are at least older than 50 years of age at Day
- •Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA
排除标准
- •Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening.
- •Have evidence of a scar, fibrosis, or atrophy of > 50% of the total lesion in the study eye.
研究组 & 干预措施
OTX-TKI (axitinib implant)
Experimental
干预措施: OTX-TKI (axitinib implant) (Drug)
Control
Other
干预措施: Aflibercept (Drug)
结局指标
主要结局
Best corrected visual acuity (BCVA)
时间窗: Up to 36 Weeks
Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss
次要结局
未报告次要终点
研究者
研究点 (105)
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相关资讯
Ocular Therapeutix Clears FDA Pre-NDA Meeting for AXPAXLI in Wet AMD, NDA Submission on Track for Q4 2026- Ocular Therapeutix completed a positive Pre-NDA meeting with the FDA for AXPAXLI (OTX-TKI) in wet age-related macular degeneration, confirming the planned NDA package.
- The NDA will rest on Week 52 efficacy and safety data from the Phase 3 SOL-1 trial, interim safety data from SOL-R, and supporting confirmatory evidence.
- Submission remains on track for the fourth quarter of 2026 under the 505(b)(2) pathway, which could shorten FDA review by up to 60 days.
- If approved, AXPAXLI could become the first tyrosine kinase inhibitor marketed for wet AMD, with commercial readiness accelerating ahead of a potential 2027 launch.yesterdayOTX-TKI Implant Shows Promise in Reducing Injection Frequency for Wet AMD- A phase I study of OTX-TKI, an intravitreal implant containing axitinib, demonstrated a significant reduction in injection frequency for wet AMD patients.
- The OTX-TKI implant resulted in a nearly 90% reduction in injection burden compared to aflibercept over a 12-month period.
- Visual acuity and central subfield thickness outcomes were stable with OTX-TKI, showing comparable efficacy to aflibercept.
- Phase III trials (SOL-1 and SOL-R) are underway to assess the durability, safety, and efficacy of repeat dosing of OTX-TKI.last year