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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Abicipar pegol 2 mg administered to the study eye by intravitreal injection
Kimura Eye and Internal Medicine Hospital
Kure, Hiroshima, Japan
Musashi Dream Clinic
Tennouji-ku, Osaka, Japan
Takeuchi Eye Clinic
Taito-ku, Tokyo, Japan
Souseikai Hakata Clinic
Fukuoka, Japan
Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
Time frame: Baseline to Week 20
Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
Time frame: Baseline to Week 20
Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
Time frame: Baseline to Week 20
Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
Time frame: 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
Time frame: Baseline to Week 20
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
Time frame: Baseline to Week 20
Serum Levels of Anti-abicipar Antibodies
Time frame: Baseline to Week 20
Percentage of Participants with Treatment Emergent Adverse Events
Time frame: Baseline to Week 20
Best Corrected Visual Acuity using an Eye Chart
Time frame: 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]
Time frame: Baseline to Week 20
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Fukushima Medical University Hospital
Fukushima, Japan
Changes from Baseline in General Physical Condition as Measured through General Physical Exam
Time frame: Baseline to Week 20
Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
Time frame: Baseline to Week 20
Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
Time frame: Baseline to Week 20