NCT02450981

Evaluation the Pharmacokinetics, Safety, Tolerability of BCD-021 in Patients With Neovascular Age-related Macular Degeneration

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Bevacizumab (BCD-021)	Bevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A)

Timeline

• Primary completion: 2016-03-01
• First posted: 2015-05-21
• Last updated: 2016-03-31