Macular Degeneration
Conditions
Brief summary
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).
Interventions
DRUGAbicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar | 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 | 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 | 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 | 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 | 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 | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Serum Levels of Anti-abicipar Antibodies | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 |
| 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 |
| Percentage of Participants with Treatment Emergent Adverse Events | 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 |
Countries
United States
Outcome results
None listed