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

Study Identifier
150998-012
CT.gov Identifier
NCT02859766
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Macular Degeneration - Other
    • Study Drug
  • Abicipar pegol
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    50+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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).

    Study Locations

    Location
    Status
    Location
    Retinal Consultants of Arizona
    Gilbert, Arizona, United States, 85296
    Status
    Not applicable
    Location
    Win Retina
    Arcadia, California, United States, 91006
    Status
    Not applicable
    Location
    Retina Vitreous Associates Medical Group
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Atlantis Retina Institute (Atlantis Eyecare)
    Huntington Beach, California, United States, 92647
    Status
    Not applicable
    Location
    Jacobs Retina Center, Shiley Eye Institute, UCSD
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    California Eye Specialists Medical Group, Inc-Private Clinic
    Pasadena, California, United States, 91107
    Status
    Not applicable
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