Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 30
- 试验地点
- 18
- 主要终点
- Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
研究概览
简要总结
This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
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
- •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 verteporfin photodynamic therapy (PDT) or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region.
- •Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD.
- •Macular hemorrhage that involves the center of fovea in the study eye.
- •Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD in the study eye.
- •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 in the non-study eye that requires anti-VEGF treatment.
研究组 & 干预措施
Abicipar Pegol_Repeat Dose
Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. [Day 1, Weeks 4 and 8]
干预措施: Abicipar pegol (Drug)
Abicipar Pegol_Single Dose
Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.
干预措施: Abicipar pegol (Drug)
结局指标
主要结局
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
时间窗: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
时间窗: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
时间窗: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
时间窗: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
时间窗: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
次要结局
- Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)(Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12)
- Serum Levels of Anti-abicipar Antibodies(Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12)
- Best Corrected Visual Acuity using an Eye Chart(Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12)
- Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam](Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12)
- Changes from Baseline in General Physical Condition as Measured through General Physical Exam(Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12)
- Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate)(Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12)
- Percentage of Participants with Treatment Emergent Adverse Events(Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12)