A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 38
- 主要终点
- Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
研究概览
简要总结
Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.
Clinical Hypotheses:
- NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD
- NT-503-3 ECT has an acceptable safety profile
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, 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
- •Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
- •Prior Intravitreal Anti-VEGF injections
排除标准
- •Significant subretinal hemorrhage
- •Significant Scar and/or, fibrosis
- •Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
- •Inadequate response to anti-VEGF therapy
研究组 & 干预措施
NT-503-3 ECT implantation
干预措施: NT-503-3 ECT implantation (Drug)
Eylea® injected intravitreally every 8 weeks
Eylea® injected intravitreally every 8 weeks
干预措施: Eylea® injected intravitreally administered every 8 weeks (Drug)
结局指标
主要结局
Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
时间窗: Week 52 and Week 108
次要结局
- Change from baseline in best corrected visual acuity (BCVA)(Week 52)
- Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy(Up to Week 108)
- Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)(Up to Week 108)