A Phase 2a Multicenter Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Sunitinib Malate Depot Formulation (GB-102) in Subjects With Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Occurrence of Adverse Events (AEs) Across All Study Visits
研究概览
简要总结
Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion
详细描述
Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels (1 mg and 2 mg) of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion who have received prior treatment with anti-vascular endothelial growth factor (VEGF)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study design
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
- •Males or females ≥ 21 years of age
- •Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
- •Demonstrated response to prior anti-VEGF treatment since diagnosis
- •BCVA of 31 letters or better
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 or IOP
- •Chronic renal disease
研究组 & 干预措施
GB-102 Dose 1 (1 mg)
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
干预措施: GB-102 (Drug)
GB-102 Dose 2 (2 mg)
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
干预措施: GB-102 (Drug)
结局指标
主要结局
Occurrence of Adverse Events (AEs) Across All Study Visits
时间窗: Baseline through Month 6
Number of subjects with an adverse event across all study visits
次要结局
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits(Baseline to Month 6)
- Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits(Baseline to Month 6)
- Time to Rescue Treatment(Baseline through Month 6)