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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Bevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A)
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to BCD-021 and appeared after the first, the second and the third intravitreal injection of BCD-021
Time frame: 85 days
Frequency of ocular and systemic AEs and SAEs related to age-related macular degeneration (AMD) therapy, appeared within the whole study period
Time frame: 12 months
Number of cases of early withdrawal from the study caused by AE or SAE
Time frame: 12 months
Area under the plasma concentration-time curve from zero (0) hours to 28 days, maximum concentration and half life of bevacizumab after the first administration of BCD-021
Time frame: 28 days
Area under the plasma concentration-time curve from 56 days to 84 days, maximum concentration and half life of bevacizumab after the third administration of BCD-021
Time frame: 28 days
Minimum concentration of bevacizumab between the first and the third administration of BCD-021
Time frame: 28 days
Number of patients who have binding and neutralizing antibodies to BCD-021 in serum at screening, after 3 intravitreal injections and after 12 intravitreal injections of BCD-021
Time frame: 12 months
Mean change in visual acuity score, measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at month 12
Time frame: 12 months
Change in fluid and foveal thickness on OCT during the study
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Time frame: 12 months
Timing of visual improvement after initiation of therapy
Time frame: 12 months