Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration

Sponsor
Biocad
Study ID
NCT02036723
Phase
PHASE3
Status
Withdrawn

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Patients will receive bevacizumab at a dose 1.25 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.
  • Ranibizumab — DRUG
    Patients will receive ranibizumab at a dose 0.50 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.

Study Details

GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021 (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related macular degeneration. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Lucentis®.

Key Dates

First listed
Jan 15, 2014
Status verified
Mar 2016
Primary completion
Mar 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BCD-021
    BCD-021 is a product code for bevacizumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm 72 patients will receive BCD-021 at a dose 1.25 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.
  • Active Comparator: Lucentis®
    Lucentis® is ranibizumab drug produced by Novartis Pharmaceuticals Canada Inc. In this arm 36 patients will receive Lucentis® at a dose 0.50 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.

Primary Outcome Measure

• Proportion of patients losing fewer than 15 letters on EDTRS chart at month 12 [ Time Frame: week 52 ]

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