A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.
详细描述
In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB-102 compared with aflibercept.
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)
盲法说明
Masking is relevant to Phase 2 only
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
- •Males or females of any race, ≥ 50 years of age
- •Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
- •Evidence of increased vascular permeability and/or loss of visual acuity
排除标准
- •History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
- •Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism
- •Chronic renal disease
- •Abnormal liver function
- •Women who are pregnant or lactating
研究组 & 干预措施
Experimental: Phase 1 - GB-102
Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102.
干预措施: GB-102 (Drug)
Experimental: Phase 2 - GB-102
Low dose or high dose injected every 6 months
干预措施: GB-102 (Drug)
Active Comparator: Phase 2 - Aflibercept
Aflibercept 2 mg injected every 2 months
干预措施: Aflibercept (Drug)
结局指标
主要结局
Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
时间窗: 8 months
Number of adverse events in total and number of subjects with an adverse event
Phase 2: Change from baseline in best corrected visual acuity by ETDRS
时间窗: Baseline, Month 9
Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)
次要结局
- Phase 1: Systemic exposure to sunitinib measured in plasma level(8 months)
- Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS(12 months)
- Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS(12 months)
- Phase 2: Change from baseline in BCVA by ETDRS(12 months)
- Phase 1: Change from baseline in BCVA by ETDRS(8 months)
- Phase 2: Occurrence of ocular and nonocular adverse events (AEs)(12 months)
- Phase 2: Systemic exposure to sunitinib measured in plasma level(12 months)
- Phase 2: Change from baseline in sub-retinal thickness(12 months)
- Phase 2: Rescue medication(12 months)
- Phase 1: Change from baseline in sub-retinal thickness(8 months)
- Phase 1: Change from baseline in retinal fluid by SD-OCT(8 months)
- Phase 1: Change from baseline in total lesion area by FA/CFP(8 months)
- Phase 1: Change from baseline in CNV lesion area by FA/CFP(8 months)
- Phase 1: Rescue medication(8 months)
- Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height(8 months)
- Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT(12 months)
- Phase 1: Change from baseline in fluorescein leakage area by FA/CFP(8 months)