NCT03814291已完成1 期
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Wet Age-related Macular Degeneration (AMD)
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
- 31
- 试验地点
- 1
- 主要终点
- Safety evaluation indicators
研究概览
简要总结
This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Male or female patient ≥ 50 yrs. of age.
- •Active subfoveal CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
- •BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
- •Central macular sub-field thickness according to OCT of at least 250 micron.
- •Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
- •Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.
- •Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
排除标准
- •Presence of other causes of CNV other than wet AMD in the study eye.
- •Presence of active diabetic retinopathy in the study eye.
- •Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
- •Prior retinal detachment in the study eye.
- •Prior any treatment of following in the study eye:
- •Anti-VEGF therapy within 6 months prior to screening;
- •Anti-complement therapy;
- •Laser photocoagulation;
- •Photodynamic therapy;
- •Transpupillary thermotherapy
- •Intraocular surgery;
- •Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;
- •Presence of any non-AMD disease that may affect visual acuity in the study eye
- •Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
- •Oral steroid drugs within 1 month before study drug administration.
- •Presence of active intraocular or periocular inflammation or infection.
- •Diabetic patients have any of the following conditions:
- •Microvascular and macrovascular complications;
- •HbA1c>7.5% when screening;
- •Receiving more than two oral hypoglycemic agents;
- •Receiving insulin or GLP-1 receptor agonist;
- •Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);
- •Presence of any following laboratory abnormality:
- •PLT<100×109/L, INR≥1.5ULN, APTT≥ 10 seconds more than ULN;
- •ALT or AST >2ULN;
- •Cr or Ur>1.5ULN;
- •Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.
研究组 & 干预措施
cohort 1 IBI302 treated with first dose level of IBI302
Experimental
干预措施: IBI302 (Drug)
cohort 2 IBI302 treated with second dose level of IBI302
Experimental
干预措施: IBI302 (Drug)
cohort 3 IBI302 treated with third dose level of IBI302
Experimental
干预措施: IBI302 (Drug)
cohort 4 IBI302 treated with fourth dose level of IBI302
Experimental
干预措施: IBI302 (Drug)
cohort 5 IBI302 treated with fifth dose level of IBI302
Experimental
干预措施: IBI302 (Drug)
cohort 6 IBI302 treated with sixth dose level of IBI302
Experimental
干预措施: IBI302 (Drug)
结局指标
主要结局
Safety evaluation indicators
时间窗: Baseline to Day43
Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events;
次要结局
- Clearance rate (CL)(Baseline to Day43)
- Half-life (t1/2)(Baseline to Day43)
- Efficacy evaluation indicators(Baseline to Day43)
- The area under the drug-time curve from 0 to time t (AUC0-t)(Baseline to Day43)
- The area under the curve at the time of 0-infinity (AUC0-∞)(Baseline to Day43)
- The peak time (Tmax)(Baseline to Day43)
- Immunogenicity evaluation indicators(Baseline to Day43)
- The peak concentration (Cmax)(Baseline to Day43)
- Free and total VEGF concentration(Baseline to Day43)
研究者
研究点 (1)
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