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

• Status: Completed
• Trial end date: 2017-10-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

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.