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    Clinical Trial Results:
    Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)

    Summary
    EudraCT number
    		 2015-001961-20
    Trial protocol
    		 CZ   AT   DE   HU   ES   FR   GB   IT  
    Global end of trial date
    08 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2021
    First version publication date
    13 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FYB201-C2015-01-P3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02611778
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    bioeq GmbH
    Sponsor organisation address
    Bergfeldstraße 9, Holzkirchen, Germany, 83607
    Public contact
    Clinical Trial Information Desk, Bioeq GmbH, columbus@bioeq.com
    Scientific contact
    Clinical Trial Information Desk, Bioeq GmbH, columbus@bioeq.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate and compare functional changes in best corrected visual acuity (BCVA) after 2 months (8 weeks) of treatment with FYB201 or Lucentis, compared to baseline BCVA
    Protection of trial subjects
    The study was in compliance with regulatory requirements, the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and with the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association. Only subjects that met all inclusion criteria and no exclusion criteria were to enter the study. All patients were free to discontinue their participation in the study at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 77
    Country: Number of subjects enrolled
    Ukraine: 14
    Country: Number of subjects enrolled
    Israel: 147
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Poland: 122
    Country: Number of subjects enrolled
    Spain: 57
    Country: Number of subjects enrolled
    United Kingdom: 30
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Czech Republic: 81
    Country: Number of subjects enrolled
    France: 37
    Country: Number of subjects enrolled
    Germany: 53
    Country: Number of subjects enrolled
    Hungary: 74
    Worldwide total number of subjects
    722
    EEA total number of subjects
    542
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    82
    From 65 to 84 years
    554
    85 years and over
    86

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included male or post-menopausal or sterile female patients of 50 years or older, who suffered from newly diagnosed subfoveal neovascular age-related macular degeneration (nAMD). Between 19-Dec-2015 and 14-Jun-2017, 712 patients were screened (10 patients were rescreened) in 75 sites in 12 countries in Europe, Russia and Israel.

    Pre-assignment
    Screening details
    		 All 712 patients were screened for eligibility before participating in the active treatment phase of the study, resulting in 722 screenings due to 10 rescreenings. Subjects were not to be entered to trial treatment if any of the eligibility criteria were violated. Of the 712 distinct patients, 477 patients were randomized and treated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This study was evaluation-masked, neither the patient nor the investigator(s) who performed evaluations knew, which treatment the patient received. In each site, there were at least 2 masked staff members and 1 unmasked injector who administered the treatment and who performed ophthalmologic pre- and post-injection assessments and questionnaire administration.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FYB201
    Arm description
    		 Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
    Arm type
    		 Experimental

    Investigational medicinal product name
    FYB201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Intravitreal injection of 0.5mg FYB201 (0.05mL of a 10mg/mL solution) given monthly

    Arm title
    		 Lucentis
    Arm description
    		 Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Intravitreal injection of 0.5mg Lucentis (0.05mL of a 10mg/mL solution) given monthly

    Number of subjects in period 1 [1]
    		FYB201 Lucentis
    Started
    238
    239
    Completed
    226
    226
    Not completed
    12
    13
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    2
    8
         Adverse event, non-fatal
    1
    2
         Other
    2
    1
         Lost to follow-up
    3
    1
         Need for alternative treatment
    1
    -
         Protocol deviation
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomized after successfully completing the screening period and received at least one injection with the investigational medicinal product.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FYB201
    Reporting group description
    		 Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections

    Reporting group title
    Lucentis
    Reporting group description
    		 Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections

    Reporting group values
    		 FYB201 Lucentis Total
    Number of subjects
    		 238 239 477
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 25 19 44
        From 65-84 years
    		 181 188 369
        85 years and over
    		 32 32 64
    Age continuous
    Safety set (SAF): The safety set comprised all patients who had received at least one injection with investigational medicinal product (IMP). The safety set was used as general analysis set for all kinds of safety and tolerability data. Patients were analyzed according to the treatment they actually received irrespective of their randomized treatment. If only single injections from the wrong treatment were administered, it was to be decided on a case by case basis how the patient was to be analyzed.
    Units: years
        arithmetic mean (standard deviation)
    		 74.9 ( 8.26 ) 76.1 ( 7.84 ) -
    Gender categorical
    SAF
    Units: Subjects
        Female
    		 135 134 269
        Male
    		 103 105 208

    End points

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    End points reporting groups
    Reporting group title
    FYB201
    Reporting group description
    		 Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections

    Reporting group title
    Lucentis
    Reporting group description
    		 Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections

    Primary: Change from baseline in best corrected visual acuity (BCVA) [letters] after 8 weeks

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    End point title
    		 Change from baseline in best corrected visual acuity (BCVA) [letters] after 8 weeks
    End point description
    The primary endpoint was the change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 2 months (8 weeks) of treatment. All patients included in the full analysis set (FAS_EU) were analysed. FAS_EU: The FAS_EU was based on the intention-to-treat principle (i.e., patients were analyzed according to their randomized treatment irrespective of the treatment they actually received) and included all patients who received at least one injection of IMP and for whom BCVA results at least after 1 month were available and who had a screening BCVA between 20/40 and 20/100 Snellen equivalent in the study eye. Overall, 429 subjects were included in the FAS_EU, 215 in the FYB201 treatment group and 214 in the Lucentis treatment group. Of these, 212 patients in the FYB201 and 214 patients in the Lucentis treatment group were still in the study after 8 weeks.
    End point type
    Primary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FYB201 Lucentis
    Number of subjects analysed
    207 [1]
    209 [2]
    Units: Letters
        arithmetic mean (standard deviation)
    5.2 ( 7.75 )
    6.0 ( 8.42 )
    Notes
    [1] - FAS_EU. 5 subjects in the FYB201 group had missing data for the BCVA assessment at Week 8.
    [2] - FAS_EU. 5 subjects in the Lucentis group had missing data for the BCVA assessment at Week 8.
    Statistical analysis title
    		 Comparison of change in BCVA [letters]
    Statistical analysis description
    The hypothesis of biosimilarity of FYB201 and Lucentis was tested with a two-sided equivalence test with an equivalence margin of 3 ETDRS letters. An ANCOVA model was used with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and the country and the treatment group as fixed effects.
    Comparison groups
    FYB201 v Lucentis
    Number of subjects included in analysis
    416
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in least square means
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.8
    Notes
    [3] - The confidence interval (CI) for treatment difference (FYB201 - Lucentis) was calculated using Least Square Means. If the 95% CI was completely contained in the interval ]-3.5;3.5[ ETDRS letters, equivalence of FYB201 and Lucentis could be concluded.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    FYB201
    Reporting group description
    		 Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections

    Reporting group title
    Lucentis
    Reporting group description
    		 Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections

    Serious adverse events
    		 FYB201 Lucentis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 238 (7.98%)
    32 / 239 (13.39%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    2
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign pancreatic neoplasm
    Additional description: Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
    Additional description: Bladder cancer
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
    Additional description: Bladder neoplasm
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
    Additional description: Meningioma benign
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
    Additional description: Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
    Additional description: Peripheral artery stenosis
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
    Additional description: Thrombophlebitis superficial
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
    Additional description: Bronchiectasis
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung disorder
    Additional description: Lung disorder
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
    Additional description: Pneumonia aspiration
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    1 / 238 (0.42%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Catheterisation cardiac
    Additional description: Catheterisation cardiac
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
    Additional description: Femoral neck fracture
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
    Additional description: Thoracic vertebral fracture
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    3 / 238 (1.26%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
    Additional description: Cardiac failure chronic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
    Additional description: Cardiopulmonary failure
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congestive cardiomyopathy
    Additional description: Congestive cardiomyopathy
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    Additional description: Myocardial infarction
         subjects affected / exposed
    1 / 238 (0.42%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
    Additional description: Cerebral haemorrhage
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
    Additional description: Headache
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 238 (0.42%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
    Additional description: Transient global amnesia
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
    Additional description: Anaemia macrocytic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    0 / 238 (0.00%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iridocyclitis
    Additional description: Iridocyclitis
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
    Additional description: Gastric ulcer
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
    Additional description: Intestinal obstruction
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
    Additional description: Bile duct stone
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    2 / 238 (0.84%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydroureter
    Additional description: Hydroureter
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
    Additional description: Nephrotic syndrome
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
    Additional description: Ureterolithiasis
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
    Additional description: Urinary bladder polyp
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 238 (0.42%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    0 / 238 (0.00%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
    Additional description: Endophthalmitis
         subjects affected / exposed
    1 / 238 (0.42%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
    Additional description: Pneumonia bacterial
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
    Additional description: Postoperative wound infection
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 FYB201 Lucentis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    149 / 238 (62.61%)
    161 / 239 (67.36%)
    Investigations
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    4 / 238 (1.68%)
    5 / 239 (2.09%)
         occurrences all number
    4
    5
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    10 / 238 (4.20%)
    5 / 239 (2.09%)
         occurrences all number
    11
    5
    Intraocular pressure increased
    Additional description: Intraocular pressure increased
         subjects affected / exposed
    11 / 238 (4.62%)
    12 / 239 (5.02%)
         occurrences all number
    20
    15
    Visual acuity tests abnormal
    Additional description: Visual acuity tests abnormal
         subjects affected / exposed
    4 / 238 (1.68%)
    5 / 239 (2.09%)
         occurrences all number
    4
    6
    Injury, poisoning and procedural complications
    Fall
    Additional description: Fall
         subjects affected / exposed
    2 / 238 (0.84%)
    5 / 239 (2.09%)
         occurrences all number
    2
    5
    Vascular disorders
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    3 / 238 (1.26%)
    14 / 239 (5.86%)
         occurrences all number
    6
    25
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    1 / 238 (0.42%)
    5 / 239 (2.09%)
         occurrences all number
    1
    5
    Headache
    Additional description: Headache
         subjects affected / exposed
    4 / 238 (1.68%)
    8 / 239 (3.35%)
         occurrences all number
    5
    9
    General disorders and administration site conditions
    Pain
    Additional description: Pain
         subjects affected / exposed
    5 / 238 (2.10%)
    2 / 239 (0.84%)
         occurrences all number
    9
    2
    Eye disorders
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    1 / 238 (0.42%)
    10 / 239 (4.18%)
         occurrences all number
    1
    13
    Choroidal neovascularisation
    Additional description: Choroidal neovascularisation
         subjects affected / exposed
    6 / 238 (2.52%)
    4 / 239 (1.67%)
         occurrences all number
    6
    4
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    14 / 238 (5.88%)
    19 / 239 (7.95%)
         occurrences all number
    24
    30
    Conjunctival hyperaemia
    Additional description: Conjunctival hyperaemia
         subjects affected / exposed
    4 / 238 (1.68%)
    6 / 239 (2.51%)
         occurrences all number
    4
    6
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    9 / 238 (3.78%)
    6 / 239 (2.51%)
         occurrences all number
    14
    8
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    9 / 238 (3.78%)
    2 / 239 (0.84%)
         occurrences all number
    11
    2
    Neovascular age-related macular degeneration
    Additional description: Neovascular age-related macular degeneration
         subjects affected / exposed
    19 / 238 (7.98%)
    22 / 239 (9.21%)
         occurrences all number
    19
    24
    Punctate keratitis
    Additional description: Punctate keratitis
         subjects affected / exposed
    8 / 238 (3.36%)
    12 / 239 (5.02%)
         occurrences all number
    15
    25
    Retinal haemorrhage
    Additional description: Retinal haemorrhage
         subjects affected / exposed
    7 / 238 (2.94%)
    3 / 239 (1.26%)
         occurrences all number
    9
    3
    Retinal pigment epithelial tear
    Additional description: Retinal pigment epithelial tear
         subjects affected / exposed
    2 / 238 (0.84%)
    6 / 239 (2.51%)
         occurrences all number
    2
    6
    Visual acuity reduced
    Additional description: Visual acuity reduced
         subjects affected / exposed
    6 / 238 (2.52%)
    11 / 239 (4.60%)
         occurrences all number
    6
    13
    Vitreous detachment
    Additional description: Vitreous detachment
         subjects affected / exposed
    6 / 238 (2.52%)
    4 / 239 (1.67%)
         occurrences all number
    7
    4
    Vitreous floaters
    Additional description: Vitreous floaters
         subjects affected / exposed
    3 / 238 (1.26%)
    5 / 239 (2.09%)
         occurrences all number
    3
    5
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    2 / 238 (0.84%)
    5 / 239 (2.09%)
         occurrences all number
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
         subjects affected / exposed
    5 / 238 (2.10%)
    5 / 239 (2.09%)
         occurrences all number
    7
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    0 / 238 (0.00%)
    5 / 239 (2.09%)
         occurrences all number
    0
    5
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    5 / 238 (2.10%)
    8 / 239 (3.35%)
         occurrences all number
    5
    8
    Infections and infestations
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    8 / 238 (3.36%)
    5 / 239 (2.09%)
         occurrences all number
    8
    5
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    9 / 238 (3.78%)
    2 / 239 (0.84%)
         occurrences all number
    10
    2
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    5 / 238 (2.10%)
    2 / 239 (0.84%)
         occurrences all number
    7
    2
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    12 / 238 (5.04%)
    16 / 239 (6.69%)
         occurrences all number
    15
    17
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    8 / 238 (3.36%)
    6 / 239 (2.51%)
         occurrences all number
    10
    7
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    3 / 238 (1.26%)
    6 / 239 (2.51%)
         occurrences all number
    3
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2015
    Additional sampling points in PK Subgroup, exclusion criterion related to acute treatment need of fellow eye at Visit 1 added
    08 Mar 2017
    Harmonization of the primary EU and US endpoint, adaption of sample size, removal of interim analysis and trough level sampling
    10 May 2017
    Local protocol version for France due to comments from the French Competent Authority.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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