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Wet Age-related Macular DegenerationPhase 3GALATIRNCT02036723

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

A Phase 3 study testing Bevacizumab and Ranibizumab in people with Wet Age-related Macular Degeneration, run by Biocad at 13 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
Bevacizumab and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
13 sitesin 2 countries
Study dates
Start not givento Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Former corneal grafting of the studied eye;
  • Medical history of auto-immune or idiopathic uveitis;
  • Proved diabetic retinopathy;
  • Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments;
  • Medical history of intra-ocular surgery within 2 months before the first injection in the studied eye;
  • Aphakia or lack of lens capsule (not removed by laser) in the studied eye;
  • Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion;
  • Known hypersensitivity to ranibizumab, bevacizumab, or another drug composite of the medicinal products used; allergy to fluorescein, indocyanine green, anaesthetic eye drops;
  • Arterial hypertension that is not controlled by an appropriate treatment;
  • Previous or current treatment with systemic administration of bevacizumab;
  • Pregnancy and breast-feeding;
  • Any determined immunodeficiency;
  • Syphilis, HIV, hepatitis B, any history of hepatitis C virus;
  • Any mental disorder, including major depression and/or suicidal thoughts in anamnesis that can, in Investigator's opinion, create a risk for the patient or influence the patient's ability to follow the study protocol;
  • Drug addiction, alcoholism.
  • Presence or history of malignant neoplasm (including lymphoproliferative disease), with the exception of: Adequately treated basal cell carcinoma and cervical carcinoma in situ; Any malignancy with complete remission of more than 5 years;
  • Simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation; previous participation in this study

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Brazil7 sites

  • Universidade Federal de Minas Gerais Hospital das Clínicas

    Belo Horizonte

  • Hospital dos Olhos do Paraná

    Curitiba, Paraná

  • Universidade Estadual de Londrina

    Londrina, Paraná

  • UERJ Hospital Universitário Pedro Ernesto

    Rio de Janeiro

  • Universidade Federal do Rio de Janeiro Hospital Clementino Fraga Filho

    Rio de Janeiro

  • Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto

    São Paulo

  • Universidade Federal de São Paulo Hospital São Paulo

    São Paulo

Other trials in Brazil

Russia6 sites

  • Republican Clinical Eye Hospital

    Kazan', Tatarstan Republic

  • Scientific and Research Institute named after Helmholtz

    Moscow

  • IRTC "Eye Microsurgery" named after academician SN Fedorov "

    Saint Petersburg

  • Municipal Advisory and Diagnostic Centre number 1

    Saint Petersburg

  • St. Petersburg State Medical University named after academician IP Pavlova

    Saint Petersburg

  • Regional Clinical Ophthalmic Hospital named TI Yeroshevsky

    Samara

Other trials in Russia

About this study

Official title: 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

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®.

Keywords
Macular Degeneration, Eye Diseases, Neovascular Macular Degeneration, Choroidal Neovascularization, Geographic Atrophy
Medical subject headings
Macular Degeneration, Eye Diseases, Choroidal Neovascularization, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called BCD-021

    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.

  • RanibizumabDrug

    Also called Lucentis®

    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 groups in NCT02036723
Study groupRoleWhat they receive
BCD-021ExperimentalBCD-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.
Receives: Drug: Bevacizumab
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.
Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • Proportion of patients losing fewer than 15 letters on EDTRS chart at month 12

    Measured: week 52

Secondary outcomes (12)

  1. • Frequency of ocular and systemic adverse events (AE) and serious adverse events (SAE) that are related, in Investigator's opinion, to AMD therapy

    Measured: week 52

  2. • Frequency of AE and SAE with toxicity level of 3-4 that are related, in Investigator's opinion, to AMD therapy

    Measured: week 52

  3. • Number of cases of early withdrawal from the study caused by AE or SAE

    Measured: week 52

  4. • Number of patients who have binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12

    Measured: screening, week 52

  5. • The mean titer of binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12

    Measured: screening, week 52

  6. • Mean change in VA score, measured on the EDTRS scale at month 12

    Measured: week 52

  7. • Average number of injections and time before re-injection

    Measured: week 52

  8. • Lesion size at month 6 and month 12 (by angiography)

    Measured: week 26, 52

  9. • Lesion leakage at month 6 and month 12

    Measured: week 26, 52

  10. • Change in fluid and foveal thickness on OCT during the study

    Measured: week 52

  11. • Retinal sensitivity measured by microperimetry at screening, at month 6 and month 12

    Measured: screening, week 26, 52

  12. • Timing of visual improvement after initiation of therapy

    Measured: week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2014 (estimated)
  2. Primary completionMar 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036723
Sponsor's protocol ID
GALATIR/BCD-021-3
Other IDs
GALATIR
Acronym
GALATIR
Status last verified
Mar 2016
First submitted
13 Jan 2014
Last updated
31 Mar 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab and Ranibizumab in people with Wet Age-related Macular Degeneration, run by Biocad at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Brazil, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• Proportion of patients losing fewer than 15 letters on EDTRS chart at month 12 (time frame: week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.

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