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

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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
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509 Southeast Riverside Drive
Stuart, Florida 34994
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Arcadia, California 91006
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Beverly Hills, California 90211
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Boston, Massachusetts 02115
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Cleveland, Ohio 44195
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Coral Gables, Florida 33146
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Gilbert, AZ
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Huntington Beach, California 92647
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Indianapolis, Indiana 46290
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9415 Campus Point Drive
La Jolla, California 92093
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Largo, Florida 33770
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Madison, Wisconsin 53716
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2619 East Colorado Boulevard
Pasadena, California 91107
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Pensacola, Florida 32503
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Portsmouth, New Hampshire 03801
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Salt Lake City, Utah 84107
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2170 Midland Road
Southern Pines, North Carolina 28387
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Winter Haven, Florida 33880
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Winter Haven, FL
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