Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
研究概览
简要总结
This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Japanese male or female patients
- •Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
排除标准
- •History of or active periocular, ocular, or intraocular infection
- •Previous use of ocular anti-angiogenic therapy within 1 month (ranibizumab), 6 weeks (pegaptanib), or 2 months (bevacizumab and aflibercept) of Day 1 for the treatment of neovascular AMD or neovascular eye diseases other than AMD
- •Macular hemorrhage that involves the center of fovea in the study eye
- •Previous use of verteporfin photodynamic therapy (PDT) or previous therapeutic radiation in the region
- •Treatment with ocular corticosteroid injections or implants within 6 months in the study eye
- •History or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months
- •AMD or neovascular eye diseases other than AMD in the non-study eye that require anti-VEGF treatment
研究组 & 干预措施
Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection
干预措施: Abicipar pegol (Drug)
结局指标
主要结局
Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
时间窗: Baseline to Week 20
Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
时间窗: Baseline to Week 20
Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
时间窗: Baseline to Week 20
Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
时间窗: Baseline to Week 20
Area Under the Serum Concentration-Time Curve from Zero to the End of the Dosing Interval "tau" (AUC0-tau) for Free and VEGF-Bound Abicipar
时间窗: Baseline to Week 20
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
时间窗: Baseline to Week 20
次要结局
- Serum Levels of Anti-abicipar Antibodies(Baseline to Week 20)
- Percentage of Participants with Treatment Emergent Adverse Events(Baseline to Week 20)
- Best Corrected Visual Acuity using an Eye Chart(Baseline to Week 20)
- Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam](Baseline to Week 20)
- Changes from Baseline in General Physical Condition as Measured through General Physical Exam(Baseline to Week 20)
- Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)(Baseline to Week 20)
- Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)(Baseline to Week 20)