A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 33
- 主要终点
- Time to First Rescue Treatment
研究概览
简要总结
Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.
详细描述
Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)
Extension Study:
To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit
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
- Single (Outcomes Assessor)
盲法说明
Visual examiner-masked
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 ≥ 50 years of age
- •Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).
- •Demonstrated response to prior anti-VEGF treatment since diagnosis
- •Best-corrected visual acuity (BCVA) of 35 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 intraocular pressure (IOP)
- •Chronic renal disease
- •Abnormal liver function
- •Women who are pregnant or lactating
研究组 & 干预措施
Aflibercept 2 mg
Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Time to First Rescue Treatment
时间窗: Baseline through 12 months
Kaplan-Meier estimate of the median time to first rescue treatment.
次要结局
- Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study(Baseline through 12 months)
- Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits(Baseline through 12 months)
- Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits(Baseline through 12 months)
- Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits(Baseline through 12 months)
- Number of Times That at Least One Rescue Criterion is Met(Baseline through 12 months)
- Time to Fulfillment of at Least One Rescue Criterion(6 months through 12 months)
- Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits(Baseline through 12 months)
- Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits(Baseline through 12 months)