Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration
GALATIR
Multicentre Double Blind Randomized Clinical Study Evaluating The Efficacy and Safety of BCD-021 (CJSC BIOCAD, Russia) and Lucentis® (Novartis Pharmaceuticals Canada Inc.) in Patients With Neovascular Wet Age-related Macular Degeneration
2 other identifiers
interventional
N/A
2 countries
13
Brief Summary
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®.
Trial Health
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13 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2014
CompletedFirst Posted
Study publicly available on registry
January 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedMarch 31, 2016
March 1, 2016
January 13, 2014
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Proportion of patients losing fewer than 15 letters on EDTRS chart at month 12
week 52
Secondary Outcomes (12)
• Frequency of ocular and systemic adverse events (AE) and serious adverse events (SAE) that are related, in Investigator's opinion, to AMD therapy
week 52
• Frequency of AE and SAE with toxicity level of 3-4 that are related, in Investigator's opinion, to AMD therapy
week 52
• Number of cases of early withdrawal from the study caused by AE or SAE
week 52
• Number of patients who have binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12
screening, week 52
• The mean titer of binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12
screening, week 52
- +7 more secondary outcomes
Study Arms (2)
BCD-021
EXPERIMENTALBCD-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.
Lucentis®
ACTIVE COMPARATORLucentis® 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Having signed a written informed consent form;
- Men and women;
- Patients must be from 50;
- Wet AMD in the study eye, defined as: Not previously treated active choroidal neovascular membrane (CNV), including retinal angiomatous proliferation (RAP), with oedema involving the fovea as demonstrated with optical coherence tomography (OCT) and fluorescein angiography (FA). FA shall not be older than 14 days at randomization;
- Best corrected VA for the studied eye ranging between 20/32 (6.3/10) and 20/320 (0.6/10) with EDTRS scale;
- Size of lesion \< 12 disk area;
- In case of occult neovessels, proof required of recent development of the lesion: loss of VA of at least 5 letters EDTRS (equivalent one line) in the last 3 months OR appearance of a subretinal hemorrhage OR increase in the size of the lesion (\> 10%) using fluorescein angiography during the last month by comparison with the last 3 months OR appearance of OCT criteria of macular oedema type, serous separation of neuro-epithelium, separation of the pigmented epithelial during the last month;
- Only one eye of each study patient may be recruited into the study. If the non-study eye is being treated with anti-VEGF therapy, or develops wet AMD, then the same drug being used in the study eye shall be used in the non-study eye. Treatment must be given double-blind in the non-study eye as well;
- Patient's ability (in Investigator's opinion) to follow the protocol procedures;
- Male and female patients with normal reproductive function and their sexual partners are aware and willing to use voluntarily reliable methods of contraception during the whole period of the study including the screening period. This requirement does not apply to patients who underwent operative sterilization or those defined as post-menopausal (confirmed by medical history documentation) within last 2 years. Reliable methods of contraception suggest using 1 barrier method in combination with 1 of the following methods: spermicides, intra-uterine device etc.
You may not qualify if:
- Previous or current treatment with intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab, aflibercept or pegaptanib, etc.) in the studied eye;
- Other healing treatment in the studied eye during the last 3 months before the first injection;
- Former vitrectomy in the study eye;;
- Medical history of photocoagulation in the studied eye;
- Involvement in another clinical study (studied eye and/or the other eye);
- Subretinal haemorrhage reaching the fovea centre, with a size \> 50% of the lesion area;
- Fibrosis or retrofoveal retinal atrophy in the studied eye;
- Retinal pigment epithelial tear reaching the macula in the studied eye;
- Choroidal neovascularisation not related to a AMD in the studied eye;
- Medical history of intravitreal medical device in the studied eye;
- Active or suspected ocular or peri-ocular infection;
- Acute conjunctivitis, keratitis, scleritis, or endophthalmitis;
- Serious active intra-ocular inflammation in the studied eye;
- Macula-foramen of the studied eye;
- Myopia larger than -8 diopter;
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Sites (13)
Hospital dos Olhos do Paraná
Curitiba, Paraná, Brazil
Universidade Estadual de Londrina
Londrina, Paraná, Brazil
Universidade Federal de Minas Gerais Hospital das Clínicas
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
Municipal Advisory and Diagnostic Centre number 1
Saint Petersburg, Russia
St. Petersburg State Medical University named after academician IP Pavlova
Saint Petersburg, Russia
Regional Clinical Ophthalmic Hospital named TI Yeroshevsky
Samara, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2014
First Posted
January 15, 2014
Primary Completion
March 1, 2016
Last Updated
March 31, 2016
Record last verified: 2016-03