OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy 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
- 27
- 试验地点
- 9
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)
详细描述
Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration
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
- •Diagnosis of neovascular age-related macular degeneration in the study eye.
- •Active subfoveal choroidal neovascularization (CNV) secondary to AMD
- •Two or more prior anti-VEGF intravitreal injections
- •EDTRS BCVA score ≤ 75 and ≥ 20 letters
排除标准
- •Any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than nAMD
- •Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for CNV
- •IOP ≥ 25mmHg or cup-to-disc ratio >0.8
- •Uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, CVA or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of GI perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study
- •Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit
研究组 & 干预措施
Cohort 3 (High-mid Dose)
Subjects will receive a high-mid dose of 0.50 mg CLS-AX
干预措施: CLS-AX (Drug)
Cohort 1 (Low Dose)
Subjects will receive a low dose of 0.03 mg CLS-AX
干预措施: CLS-AX (Drug)
Cohort 1 (Low Dose)
Subjects will receive a low dose of 0.03 mg CLS-AX
干预措施: Anti-VEGF (Drug)
Cohort 2 (Low-mid Dose)
Subjects will receive a low-mid dose of 0.10 mg CLS-AX
干预措施: CLS-AX (Drug)
Cohort 2 (Low-mid Dose)
Subjects will receive a low-mid dose of 0.10 mg CLS-AX
干预措施: Anti-VEGF (Drug)
Cohort 3 (High-mid Dose)
Subjects will receive a high-mid dose of 0.50 mg CLS-AX
干预措施: Anti-VEGF (Drug)
Cohort 4 (High Dose)
Subjects will receive a high-mid dose of 1.0 mg CLS-AX
干预措施: CLS-AX (Drug)
Cohort 4 (High Dose)
Subjects will receive a high-mid dose of 1.0 mg CLS-AX
干预措施: Anti-VEGF (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Day 1 to Week 12
Number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Number of Participants With Serious Adverse Events
时间窗: Day 1 to Week 12
Number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
次要结局
- Maximum Plasma Concentration [Cmax] of Axitinib(Day 1 to Week 12)
- Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections(From Day 1 to Week 12)
- Mean Change From Baseline (Visit 2) in Central Subfield Thickness (CST) in the Study Eye(Weeks 4, 8 and 12)
- Mean Change From Baseline in Pre Injection Intraocular Pressure (IOP)(Weeks 4, 8 and 12.)
- Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections(Day 1 to Week 12)
- Mean Change From Baseline (Visit 2) in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye(Weeks 4, 8 and 12)