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

Status:	Completed
Conditions:	Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	50 - Any
Updated:	2/10/2018
Start Date:	December 7, 2016
End Date:	October 20, 2017

Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration

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).

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.

We found this trial at

sites

Win Retina

Arcadia, California 91006

from

Arcadia, CA