Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Abicipar pegol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese male or female patients Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abicipar pegol<br>Abicipar pegol 2 mg administered to the study eye by intravitreal injection | Drug: Abicipar pegol<br>* Abicipar pegol 2 mg administered to the study eye by intravitreal injection<br>* Other names: AGN-150998;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar |  | Baseline to Week 20 | 
| Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar |  | Baseline to Week 20 | 
| Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar |  | Baseline to Week 20 | 
| Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar |  | 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 |  | Baseline to Week 20 | 
| Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar |  | Baseline to Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |