Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
Multicentre Open Label Non-randomized Clinical Study Evaluating Pharmacokinetics, Safety, Tolerability of Multiple Intravitreal Injections of BCD-021 (CJSC BIOCAD, Russia) in Patients With Neovascular Wet Age-related Macular Degeneration
This clinical study is a phase 1 study which carried out to to evaluate the safety, pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.
BCD-021-1 is an open label, non-comparative, non-randomized, multicenter phase 1 clinical
study evaluating pharmacokinetics, safety and tolerability of multiple intravitreal
injections of BCD-021 (bevacizumab biosimilar, CJSC BIOCAD) when given in patients with
exudative (wet) age-related macular degeneration.
The study will enrol 10 patients with confirmed neovascular wet age-related macular
degeneration. Before inclusion into the active phase of the study, patients will undergo a
diagnostic examination during the screening period with a maximum duration of 28 days.
The principal part of the study includes the period from the first intravitreal injection
and until 28 days after the third intravitreal injection. The goal of this stage is to
evaluate pharmacokinetics, the safety and tolerability of multiple intravitreal injections
of BCD-021 (CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related
macular degeneration.
Extension phase of the study (month 4 - month 12) is required to assess the long-term
effects of the therapy and get full information about the immunogenicity of the study drug.
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Intervention Model: Single Group Assignment, Masking: Open Label
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