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

• Status: Completed
• Trial end date: 2018-10-08
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Allergan

Criteria

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