A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 178
- 主要终点
- Time to reach tumor progression
研究概览
简要总结
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
详细描述
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Subject, Assessor, and Sponsor masked trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- •Have no evidence of metastatic disease confirmed by imaging
- •Be treatment naive for IL/CM (subjects who received PDT may be eligible)
排除标准
- •Have known contraindications or sensitivities to the study drug or laser
- •Active ocular infection or disease
研究组 & 干预措施
High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
干预措施: Suprachoroidal Microinjector (Device)
High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
干预措施: Infrared Laser (Device)
Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
干预措施: Suprachoroidal Microinjector (Device)
Sham control arm & sham laser
Sham injection + sham laser
干预措施: Sham Infrared Laser (Device)
Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
干预措施: Infrared Laser (Device)
Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
干预措施: Bel-sar (Drug)
High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
干预措施: Bel-sar (Drug)
Sham control arm & sham laser
Sham injection + sham laser
干预措施: Sham Microinjector (Device)
结局指标
主要结局
Time to reach tumor progression
时间窗: 65 weeks
Tumor Progression
次要结局
- Time to composite endpoint(65 weeks)