Macular Degeneration
Conditions
Brief summary
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).
Interventions
DRUGAbicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Serum Levels of Anti-abicipar Antibodies | Baseline to Week 20 |
| Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) | 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 |
Countries
Japan
Outcome results
None listed