A Phase 1/2 Multicenter, Multidose, Dose Escalation Study to Evaluate the Safety, Tolerability and Clinical Activity of RXI-109 Administered by Intravitreal Injection to Reduce the Progression of Subretinal Fibrosis in Subjects With Advanced Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results
研究概览
简要总结
This study is designed to evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration (NVAMD).
详细描述
Evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple doses of RXI-109 when administered by intravitreal injection. Evaluate the clinical activity of single and multiple doses of RXI-109 when administered by intravitreal injection. Study participation is intended to be seven months from time of initial treatment with RXI-109.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/100 potentially due to subretinal fibrosis involving the fovea
- •BCVA ≥20/800 in the contralateral eye and better than the study eye
- •≥50 years of age
- •Subfoveal choroidal neovascularization (CNV) of any type
排除标准
- •Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis
- •Evidence of inflammation (Grade 1 or higher) in the anterior or posterior chamber
研究组 & 干预措施
RXI-109
Intravitreal injections of RXI-109 in one eye given on Day 1 and at monthly intervals through Month 3 for a total of four doses
干预措施: RXI-109 (Drug)
结局指标
主要结局
Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results
时间窗: Seven (7) months
Assess severity and frequency of reported adverse events graded by CTCAE, ophthalmological exams to assess clinically relevant changes in ocular health, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel, and monitoring for any change in best corrected visual acuity (BCVA)
Pharmacokinetic profile of RXI-109 in blood
时间窗: Four (4) months
Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections
次要结局
- Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.(Seven (7) months)
- Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart(Seven (7) months)