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

Allergan

Status and phase: Completed; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: Abicipar pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02859766

150998-012

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Abicipar Pegol_Repeat Dose

Experimental group

Description:

Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. \[Day 1, Weeks 4 and 8\]

Treatment:

Drug: Abicipar pegol

Abicipar Pegol_Single Dose

Experimental group

Description:

Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.

Treatment:

Drug: Abicipar pegol