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

Completed · Phase 1

Conditions studied: Macular Degeneration

In brief

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).

Key facts

Study ID

NCT02859766

Run by

Allergan

People needed

30

Starts

2016-12-07

Expected to finish

2017-10-20

Last updated by the study team

2018-02-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

You may not qualify if…

• 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.

Where it is running

• Retinal Consultants of Arizona — Gilbert, Arizona, United States
• Win Retina — Arcadia, California, United States
• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Atlantis Retina Institute (Atlantis Eyecare) — Huntington Beach, California, United States
• Jacobs Retina Center, Shiley Eye Institute, UCSD — La Jolla, California, United States
• California Eye Specialists Medical Group, Inc-Private Clinic — Pasadena, California, United States
• University of Miami — Coral Gables, Florida, United States
• The Eye Institute of West Florida — Largo, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• East Florida Eye Insititute — Stuart, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Raj K. Maturi, MD — Indianapolis, Indiana, United States
• Massachusetts Eye & Ear — Boston, Massachusetts, United States
• Eyesight Ophthalmic Services, PA — Portsmouth, New Hampshire, United States
• Caroline Eye Associates — Southern Pines, North Carolina, United States
• Cole Eye Institute, Cleveland Clinic — Cleveland, Ohio, United States
• Rocky Mountain Retina Consultants — Salt Lake City, Utah, United States
• Davis Duehr Dean — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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