A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
详细描述
AIV007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (VEGFR 1, -2 & -3); fibroblast growth factor receptors (FGFR-1, -2, -3 & -4); and platelet-derived growth factor receptors (PDGFR-α & β)1. Lenvatinib is the active pharmaceutical ingredient in AIV007 formulation that is FDA-approved for oral administration for patients with advanced renal cell carcinoma (RCC), differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced endometrial carcinoma (Lenvima USPI 2021; NDA 206947). AIV007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. This monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. A single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subjects aged ≥ 50 years
- •Subjects must provide written informed consent before any study-related procedures are performed
- •Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent
- •BCVA in the study eye
- •Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse
- •All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent)
- •Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging
排除标准
- •Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy
- •Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline
- •Presence of diabetic retinopathy or glaucoma in either eye
- •Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery)
- •Presence of active infection or inflammation within 30 days prior to screening
- •Presence of contraindications to anti-VEGF treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline
- •Uncontrolled hypertension or diabetes mellitus
研究组 & 干预措施
AIV007 Treatment Dose 1
Intravitreal, Dose 1
干预措施: AIV007 (Drug)
AIV007 Treatment Dose 2
Intravitreal, Dose 2
干预措施: AIV007 (Drug)
AIV007 Treatment Dose 3
Intravitreal, Dose 3
干预措施: AIV007 (Drug)
结局指标
主要结局
Adverse Events
时间窗: approximately 224 days
Incidence of adverse events
次要结局
- Mean change from baseline in BCVA(approximately 224 days)
- Mean change from baseline in central subfield thickness as measured by optical coherence tomography(approximately 224 days)
- Mean time to rescue medication (administration of anti-VEGF medication)(approximately 224 days)