CTRI/2025/04/085831招募中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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 825
- 试验地点
- 20
- 主要终点
- Mean change in best corrected visual acuity (BCVA)
研究概览
简要总结
This study consists of a 24-week screening and run-in period prior to Day 1,
followed by an active study treatment period from Day 1 to Week 40 (Visit 17),
with a follow-up period through Week 48 (Visit 19). The primary analysis is at
Week 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with a diagnosis of active macular choroidal neovascularization (MNV) secondary to nAMD, who are at least 50 years of age, whose study eye either is treatment naive, or was diagnosed with nAMD within 4 months prior to screening and received 1 to 3 consecutive monthly (approximately every 4 weeks) anti-VEGF injections (except Beovu®) prior to Screening.
排除标准
- •Presence of a disease other than CNV due to AMD in the study eye that could affect vision or safety assessments.
结局指标
主要结局
Mean change in best corrected visual acuity (BCVA)
时间窗: Change from baseline to Week 48
次要结局
- Change in letters on ETDRS at Week 48(Week 48)
研究者
Dr Saurendra Das
PFC Pharma Focus India Pvt Ltd
研究点 (20)
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