NCT07402876招募中3 期
A Prospective, Randomized, Double-masked, Dosing-frequency-controlled, Multicenter Clinical Trial Evaluating the Safety and Activity of Intravitreally Injected ADX-2191 (Methotrexate Injection USP) in Patients With Primary Vitreoretinal Lymphoma
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment
研究概览
简要总结
A prospective, randomized, double-masked, dosing-frequency-controlled, multicenter clinical trial evaluating the safety and activity of intravitreally injected ADX-2191 (methotrexate injection USP) in patients with primary vitreoretinal lymphoma
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years old or older; of any gender
- •Biopsy proven primary vitreoretinal lymphoma
- •Presence of lymphomatous vitreous cells at the Screening Visit and/or any eye that has been vitrectomized to confirm the diagnosis of primary vitreoretinal lymphoma
- •Willingness to participate in the clinical trial as evidenced by signing of an informed consent
排除标准
- •Known allergy or hypersensitivity to methotrexate
- •Planned eye surgery during the clinical trial
- •Women of childbearing potential who are pregnant or lactating
- •Pre-existing ocular or non-ocular conditions or diseases that, in the opinion of the investigator, could interfere with the conduct or interpretation of the clinical trial
- •Use of systemic methotrexate within one week prior to treatment
研究组 & 干预措施
Induction/Consolidation/Maintenance (ICM) ADX-2191 injection
Experimental
干预措施: ICM ADX-2191 injection (Drug)
Monthly ADX-2191 injection
Active Comparator
干预措施: Monthly ADX-2191 injection (Drug)
结局指标
主要结局
Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment
时间窗: Eight weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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