NCT04370379已完成1 期
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
研究概览
简要总结
This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
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
- 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
- •Inclusion criteria
- •Male or female patient ≥ 50 yrs. of age.
- •Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- •Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- •Exclusion criteria
- •Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
- •Presence of active intraocular or periocular inflammation or infection;
- •History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- •Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
- •Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;
排除标准
- 未提供
研究组 & 干预措施
low dose of IBI302
Experimental
干预措施: IBI302 (the first dose level) (Drug)
high dose of IBI302
Experimental
干预措施: IBI302 (the second dose level) (Drug)
2mg aflibercept
Active Comparator
干预措施: Aflibercept (Drug)
结局指标
主要结局
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
时间窗: Baseline to Day140
Incidence of adverse events
时间窗: Baseline to Day140
次要结局
- Changes in central subfield thickness by OCT compared with baseline(Baseline to Day140)
- Changes in CNV characteristics and CNV area by FA compared with baseline(Baseline to Day140)
- Changes in BCVA compared with baseline(Baseline to Day140)
- the area under the curve at the time of 0-infinity of IBI302(Baseline to Day140)
- Positive rate of anti-drug antibody and neutralizing antibody of IBI302(Baseline to Day140)
- the area under the drug-time curve from 0 to time t of IBI302(Baseline to Day140)
- The peak concentration of IBI302(Baseline to Day140)
- The peak time of IBI302(Baseline to Day140)
- Clearance rate of IBI302(Baseline to Day140)
- Half-life of IBI302(Baseline to Day140)
- VEGF concentration(Baseline to Day140)
- Concentration of complement fragments(Baseline to Day140)
研究者
研究点 (1)
Loading locations...
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