A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Incidence of targeted adverse events occurring in the study eye
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.
详细描述
Following a single administration, patients will be followed for 6 months postinjection.
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
- Double (Participant, Outcomes Assessor)
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
- •Willing to give written informed consent, make the required study visits and follow instructions;
- •The study eye:
- •must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD;
- •lesion must be no larger than 30 mm2;
- •must have edema measuring greater than 340 μm;
- •must have a visual score between 73 and 34 letters, inclusive;
- •must be able to have clear picture taken of the back of the eye;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •The study eye must not have been treated for exudative AMD previously;
- •The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye;
- •The study eye must not have uncontrolled glaucoma;
- •The study eye must not be missing a lens;
- •Must not be taking any medication that is toxic to the lens;
- •Must not be taking oral or ocular corticosteroids;
- •Must not have an unstable or progressive condition that would interfere with study visits;
- •Must not have allergies to any component of the test article or sensitivity to fluorescein dye;
- •If female, must not be pregnant or nursing and must agree to adequate birth control;
- •Must not be participating in another drug or device study within 30 days of screening for this study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-39324 Concentration Level A
AL-39324 ophthalmic suspension, single intravitreal injection
干预措施: AL-39324 ophthalmic suspension (Drug)
AL-39324 Concentration Level B
AL-39324 ophthalmic suspension, single intravitreal injection
干预措施: AL-39324 ophthalmic suspension (Drug)
AL-39324 Concentration Level C
AL-39324 ophthalmic suspension, single intravitreal injection
干预措施: AL-39324 ophthalmic suspension (Drug)
AL-39324 Concentration Level D
AL-39324 ophthalmic suspension, single intravitreal injection
干预措施: AL-39324 ophthalmic suspension (Drug)
AL-39324 Concentration Level E
AL-39324 ophthalmic suspension, single intravitreal injection
干预措施: AL-39324 ophthalmic suspension (Drug)
Lucentis
Ranibizumab 10 mg/mL solution, single intravitreal injection
干预措施: Ranibizumab 10 mg/mL (Drug)
结局指标
主要结局
Incidence of targeted adverse events occurring in the study eye
时间窗: Up to Day 7 after injection
次要结局
- Mean change from baseline in central foveal thickness (CFT) at Month 1(Baseline (Day 0), Month 1)