NCT04564937Unknown1 期
A Multicenter, Open-label, Multi-dose, Phase I / II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamic Characteristics of SCT510A in the Patients With Wet Age-related Macular Degeneration.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 66
- 主要终点
- Dose-Limiting toxicity(DLT)
研究概览
简要总结
Multicenter ，open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody（SCT510A）
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form;
- •Age≥45 years，≤80 years，male or femal;
- •The study eye must meet the following criteria： Diagnosis of wAMD； Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to AMD； Total area of all types of lesions ≤12 optic disc areas（30mm2）； Best-corrected visual acuity of the study eye 70 letters or worse(Snellen equivalent of 20/40 or worse)； No optometric media opacity and pupil shrinkage.
- •Best-corrected visual acuity of the fellow eye 19 letters or better（Snellen equivalent of 20/400 or better）.
排除标准
- •The study eye suffers structural damage of retinal which involves fovea，and the investigator assess that there is a risk of retinal detachment；
- •Significant afferent pupillary defect (APD) in the study eye；
- •The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens；
- •In addition to AMD，there are other obvious eye diseases/conditions，such as pseudoexfoliation syndrome，rhegmatogenous retinal detachment，macular hole，diabetic retinopathy and diabetic macular disease which need to be treated；
- •CNV caused by other causes other than wAMD, such as vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc；
- •Uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg after antiglaucoma treatment),or recevied glaucoma filtering surgery；
- •History of vitreous hemorrhage in the study eye within 2 months before the first administration；
- •Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, endophthalmitis, or uveitis，ect；
- •Previous intraocular surgery ，or laser therapy for wAMD(as photodynamic therapy,transpupillary thermotherapy,etc.) in the study eye within 3 months before the first administration；
- •Previous intraocular or periocular injection of anti-VEGF or corticosteroid drugs (such as ranibizumab, bevacizumab, conbercept, aflibercept, brolucizumab, pegaptanib sodium, anecortave acetate, triamcinolone acetonide, etc.) in either eye within 3 months before the first administration；
- •History of allergy to fluorescein sodium or indocyanine green；
- •PLT≤100×109/L；thrombin time and prothrombin time exceed the upper limit of normal range (based on the laboratory normal value of clinical trial institution), and the abnormality is clinically significant according to the evaluation of the investigators；
- •Abnormal liver and kidney function；
- •Uncontrolled blood pressure control，systolic blood pressure≥160mmhg ,or diastolic blood pressure≥100mmhg；
- •History of surgery within one month before the first administration, or current non-healing wound, ulcer, or fracture，etc；
- •Patients with any of the following serious systemic diseases，such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors, systemic immune system diseases, diabetes mellitus with uncontrolled blood sugar(HbA1c>10%), disseminated intravascular coagulation and significant bleeding tendency；
- •Suffering from systemic infectious diseases requiring oral, intramuscular or intravenous administration；
- •Pregnant, lactating women and the patients who can not take contraceptive measures.
研究组 & 干预措施
SCT510A dose level 1 treatment
Experimental
SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously
干预措施: SCT510A (Drug)
SCT510A dose level 2 treatment
Experimental
SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously
干预措施: SCT510A (Drug)
SCT510A dose level 3 treatment
Experimental
SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously
干预措施: SCT510A (Drug)
SCT510A dose level 4 treatment
Experimental
SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously
干预措施: SCT510A (Drug)
结局指标
主要结局
Dose-Limiting toxicity(DLT)
时间窗: From Day 0 up to Day 14
Incidence of dose-limiting toxicities up to the Day 14 visit
Maximum tolerated dose(MTD）
时间窗: From Day 0 up to Day 140
Maximum tolerated dose
次要结局
- PK profile(From Day 0 up to 84 days)
- Cmax(From Day 0 up to 84 days)
- Tmax(From Day 0 up to 84 days)
- Biomarker(From Day 0 up to 84 days)
- t1/2(From Day 0 up to 84 days)
- Immunogenicity(From Day 0 up to 112 days)
- central retina thickness（CRT）(From Day 0 up to 140 days)
- Macular edema volume(From Day 0 up to 140 days)
- Best corrected visual acuity（BCVA）(From Day 0 up to 140 days)
研究者
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