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 |
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).
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
18
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2619 East Colorado Boulevard
Pasadena, California 91107
Pasadena, California 91107
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