CTIS2023-504655-27-00进行中（未招募）1 期
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 - AU-011-301
Aura Biosciences Inc.0 个研究点目标入组 267 人开始时间: 2023年11月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 267
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) with documented early growth, Have no evidence of metastatic disease confirmed by imaging, Be treatment naïve for their IL/CM (Note: eligibility for subjects who have received treatment with photodynamic therapy >12 months prior to enrollment should be discussed with the medical monitor for approval prior to enrollment).
排除标准
- •Any active eye infection or ocular disease in the study eye (other than IL/CM), Have known contraindications or sensitivities to the study drug or laser, Have a history of any ocular surgery/procedure that could alter the SCS and affect the SC administration of study drug (e.g., scleral buckle, laser retinopexy, macular laser, or panretinal photocoagulation).
研究者
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