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®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
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.
Hospital dos Olhos do Paraná
Curitiba, Paraná, Brazil
Universidade Estadual de Londrina
Londrina, Paraná, Brazil
Universidade Federal de Minas Gerais Hospital das Clínicas
• Proportion of patients losing fewer than 15 letters on EDTRS chart at month 12
Time frame: week 52
• Frequency of ocular and systemic adverse events (AE) and serious adverse events (SAE) that are related, in Investigator's opinion, to AMD therapy
Time frame: week 52
• Frequency of AE and SAE with toxicity level of 3-4 that are related, in Investigator's opinion, to AMD therapy
Time frame: week 52
• Number of cases of early withdrawal from the study caused by AE or SAE
Time frame: week 52
• Number of patients who have binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12
Time frame: screening, week 52
• The mean titer of binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12
Time frame: screening, week 52
• Mean change in VA score, measured on the EDTRS scale at month 12
Time frame: week 52
• Average number of injections and time before re-injection
Time frame: week 52
• Lesion size at month 6 and month 12 (by angiography)
Time frame: week 26, 52
• Lesion leakage at month 6 and month 12
Time frame: week 26, 52
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Belo Horizonte, Brazil
UERJ Hospital Universitário Pedro Ernesto
Rio de Janeiro, Brazil
Universidade Federal do Rio de Janeiro Hospital Clementino Fraga Filho
Rio de Janeiro, Brazil
Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto
São Paulo, Brazil
Universidade Federal de São Paulo Hospital São Paulo
São Paulo, Brazil
Republican Clinical Eye Hospital
Kazan', Tatarstan Republic, Russia
Scientific and Research Institute named after Helmholtz
Moscow, Russia
IRTC "Eye Microsurgery" named after academician SN Fedorov "
Saint Petersburg, Russia
...and 3 more locations
• Change in fluid and foveal thickness on OCT during the study
Time frame: week 52
• Retinal sensitivity measured by microperimetry at screening, at month 6 and month 12
Time frame: screening, week 26, 52
• Timing of visual improvement after initiation of therapy
Time frame: week 52