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

Allergan

Status and phase

Completed

Phase 1

Conditions

Macular Degeneration

Treatments

Drug: Abicipar pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT03335852

1771-101-008

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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