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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Retinal Consultants of Arizona
Gilbert, Arizona, United States
Win Retina
Arcadia, California, United States
Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Serum Levels of Anti-abicipar Antibodies
Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Percentage of Participants with Treatment Emergent Adverse Events
Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Atlantis Retina Institute (Atlantis Eyecare)
Huntington Beach, California, United States
Jacobs Retina Center, Shiley Eye Institute, UCSD
La Jolla, California, United States
California Eye Specialists Medical Group, Inc-Private Clinic
Pasadena, California, United States
University of Miami
Coral Gables, Florida, United States
The Eye Institute of West Florida
Largo, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
East Florida Eye Insititute
Stuart, Florida, United States
...and 8 more locations
Best Corrected Visual Acuity using an Eye Chart
Time frame: 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]
Time frame: 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
Time frame: 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)
Time frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
Time frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12