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

Study Identifier
1771-101-008
CT.gov Identifier
NCT03335852
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:
    * Japanese male or female patients * 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 ocular anti-angiogenic therapy within 1 month (ranibizumab), 6 weeks (pegaptanib), or 2 months (bevacizumab and aflibercept) of Day 1 for the treatment of neovascular AMD or neovascular eye diseases other than AMD * Macular hemorrhage that involves the center of fovea in the study eye * Previous use of verteporfin photodynamic therapy (PDT) or previous therapeutic radiation in the region * 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 or neovascular eye diseases other than AMD in the non-study eye that require anti-VEGF treatment

    Protocol Summary

    This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).

    Study Locations

    Location
    Status
    Location
    Kimura Eye and Internal Medicine Hospital
    Kure, Hiroshima, Japan, 737-0029
    Status
    Not applicable
    Location
    Musashi Dream Clinic
    Tennouji-ku, Osaka, Japan, 543-0027
    Status
    Not applicable
    Location
    Takeuchi Eye Clinic
    Taito-ku, Tokyo, Japan, 111-0051
    Status
    Not applicable
    Location
    Souseikai Hakata Clinic
    Fukuoka, Japan, 812-0025
    Status
    Not applicable
    Location
    Fukushima Medical University Hospital
    Fukushima, Japan, 960-1295
    Status
    Not applicable