An Exploratory Single Site, Open Label, Randomized, Controlled Study to Evaluate Plasma Vascular Endothelial Growth Factor Levels After Intravitreal Injection of Ranibizumab (Lucentis) and Conbercept (Langmu) for nAMD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)
研究概览
简要总结
An exploratory single site, open label, randomized, controlled study evaluated plasma vascular endothelial growth factor levels after intravitreal injection of ranibizumab (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration
详细描述
This prospective, randomized, open label study enrolled patients with neovascular AMD who were naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the previous 3 months. Patients were randomized in two treatment arms for 3 months:
- Study arm 1: Three monthly injections of 0.5mg Ranibizumab
- Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum) was collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28, following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff was blinded for treatment allocation.
Plasma VEGF concentration was measured by a blinded laboratory using Quantikine® ELISA kits. Serum ranibizumab and conbercept concentration will be determined using validated ELISA assay.
The study was divided into 2 stages: the 1st initial feasibility stage with 6 patients per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to confirm the findings with justified sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Male or female patient ≥ 50 years of age.
- •Subfoveal CNV secondary to nAMD.
- •BCVA score must be between 73 and 24 letters as measured by ETDRS chart
排除标准
- •For both eyes
- •Any active periocular or ocular infection or inflammation
- •Uncontrolled glaucoma
- •Neovascularization of the iris or neovascular glaucoma. For study eye
- •Choroidal neovascularization of any other cause than wet AMD
- •Ocular disorders present that may confound interpretation of study results,
- •Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
- •Structural damage within 0.5 disc diameter of the center of the macula
- •Atrophy or fibrosis involving the center of the fovea.
- •Inability of obtaining required lab report. Ocular medical history
- •History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment
- •Any type of systemic disease or its treatment
- •Any patients diagnosed with tumor.
- •Stroke or myocardial infarction less than 3 months.
- •Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.
- •Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient
- •Patients who have participated in other investigational drug study within 60 days.
- •Pregnant or nursing (lactating) women.
- •Inability to comply with study or follow-up procedures.
研究组 & 干预措施
Ranibizumab 0.5 mg
Three monthly injections of 0.5mg Ranibizumab
干预措施: ranibizumab (Drug)
Conbercept 0.5 mg
Three monthly injections of 0.5mg Conbercept
干预措施: Conbercept (Drug)
结局指标
主要结局
Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)
时间窗: Baseline, Visit 5 (Day 8 +/- 1 day)
Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after first injection at Visit 5 (Day 8 +/- 1 day).Blood sample was collected for systemic VEGF. VEGF was measured by a blinded laboratory using ELISA kits.
次要结局
- Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)(Baseline, Visit 10 (Day 67 +/- 1 day))
- Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection(Baseline, Visit 2, 3, 4, 5, 6)
- Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection(Baseline, Visit 7, 8, 9, 10, 11)