Status:
COMPLETED
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD
Lead Sponsor:
Allergan
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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 injec...
Eligibility Criteria
Inclusion
- Japanese male or female patients
- Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Exclusion
- 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
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03335852
Start Date
November 28 2017
End Date
October 8 2018
Last Update
November 1 2018
Active Locations (5)
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1
Kimura Eye and Internal Medicine Hospital
Kure, Hiroshima, Japan, 737-0029
2
Musashi Dream Clinic
Tennouji-ku, Osaka, Japan, 543-0027
3
Takeuchi Eye Clinic
Taito-ku, Tokyo, Japan, 111-0051
4
Souseikai Hakata Clinic
Fukuoka, Japan, 812-0025