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

Sponsor
Biocad
Study ID
NCT02450981
Phase
PHASE1
Status
Withdrawn

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab (BCD-021) — DRUG
    Bevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A)

Study Details

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.

Key Dates

First listed
May 21, 2015
Status verified
Mar 2016
Primary completion
Mar 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP

Arms

  • Experimental: BCD-021 group
    BCD-021 (bevacizumab) at a dose of 1.25 mg, administered as single intravitreal injection every 28 days up to 12 months.

Primary Outcome Measure

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 ]

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