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    Clinical Trial Results:
    A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration

    Summary
    EudraCT number
    		 2018-002930-19
    Trial protocol
    		 EE   LT   HU   SK   LV   CZ   BG   PL   ES   RO  
    Global end of trial date
    11 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2023
    First version publication date
    02 Apr 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    XBR1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03805100
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Xbrane Biopharma
    Sponsor organisation address
    Retzius väg 8, Solna, Sweden, 171 65
    Public contact
    Clinical Affairs, Xbrane Biopharma, +46 (0) 85-590 56 00, info@xbrane.com
    Scientific contact
    Clinical Affairs, Xbrane Biopharma, +46 (0) 85-590 56 00, info@xbrane.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
    07 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate that the proposed biosimilar candidate Xlucane is equivalent to Lucentis® in subjects with wAMD as assessed by the change in BCVA from Baseline to Week 8.
    Protection of trial subjects
    Subjects were monitored onsite prior to and following each injection (for at least 60 minutes) to permit any early treatment and appropriate management if needed. Subjects were advised that the days following study medication administration, they were at risk of developing endophthalmitis. If they patient experienced red eye, sensitivity to light, pain or developed a change in vision they were instructed to seek immediate care from the study doctor or an ophthalmologist. Other medications that were considered necessary for the subject’s welfare and that were not expected to interfere with the evaluation of the study medication could be given at the discretion of the Investigator, with the exceptions: • Any systemic treatment or ocular treatment with an investigational agent • Systemic anti-VEGF therapy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Slovakia: 20
    Country: Number of subjects enrolled
    Spain: 41
    Country: Number of subjects enrolled
    Bulgaria: 36
    Country: Number of subjects enrolled
    Czechia: 49
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Hungary: 89
    Country: Number of subjects enrolled
    Latvia: 10
    Country: Number of subjects enrolled
    Lithuania: 7
    Country: Number of subjects enrolled
    India: 83
    Country: Number of subjects enrolled
    Israel: 86
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    Ukraine: 20
    Country: Number of subjects enrolled
    United States: 75
    Worldwide total number of subjects
    582
    EEA total number of subjects
    302
    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)
    69
    From 65 to 84 years
    438
    85 years and over
    75

    Subject disposition

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    Recruitment
    Recruitment details
    		 582 enrolled and randomized in a 1:1 ratio to receive either Lucentis® or Xlucane (ranibizumab; Ximluci®) in the study eye once every 4 weeks for 52 weeks.

    Pre-assignment
    Screening details
    		 Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Best Corrected Visual Acuity (BCVA) of ≤ 73 and ≥ 49 ETDRS letter score in the study eye Age ≥ 50 years at screening

    Period 1
    Period 1 title
    Overall trial (complete study duration) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lucentis
    Arm description
    		 Ranibizumab, Intravitreal injection of 0.05ml (0.5mg)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Inravitreal injection of 0.05ml (0.5mg)

    Investigational medicinal product name
    Xlucane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Intravitreal injection of 0.05ml (0.5mg)

    Arm title
    		 Xlucane
    Arm description
    		 Ranibizumab Biosimilar Registered product Ximluci®, Intravitreal injection of 0.05ml (0.5mg)
    Arm type
    		 Ranibizumab Biosimilar

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Lucentis Xlucane
    Started
    290
    292
    Completed
    241
    245
    Not completed
    49
    47
         Treatment failure, as assesed by the investigator
    1
    1
         Adverse event, serious fatal
    1
    4
         Consent withdrawn by subject
    22
    17
         Noncompliance with study drug or stude schedule
    1
    -
         Adverse event, non-fatal
    10
    5
         Unspecified
    8
    15
         Lost to follow-up
    6
    4
         Use of non permitted concurrent therapy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lucentis
    Reporting group description
    		 Ranibizumab, Intravitreal injection of 0.05ml (0.5mg)

    Reporting group title
    Xlucane
    Reporting group description
    		 Ranibizumab Biosimilar Registered product Ximluci®, Intravitreal injection of 0.05ml (0.5mg)

    Reporting group values
    		 Lucentis Xlucane Total
    Number of subjects
    		 290 292 582
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 35 34 69
        From 65-84 years
    		 220 218 438
        85 years and over
    		 35 40 75
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 74 (68 to 79) 74 (69 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 157 168 325
        Male
    		 133 124 257

    End points

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    End points reporting groups
    Reporting group title
    Lucentis
    Reporting group description
    		 Ranibizumab, Intravitreal injection of 0.05ml (0.5mg)

    Reporting group title
    Xlucane
    Reporting group description
    		 Ranibizumab Biosimilar Registered product Ximluci®, Intravitreal injection of 0.05ml (0.5mg)

    Primary: Change in BCVA letters at Week 8 compared to baseline using the ETDRS protocol

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    End point title
    		 Change in BCVA letters at Week 8 compared to baseline using the ETDRS protocol
    End point description
    All statistical analyses were performed using SAS® version 9.4. In general, data were summarised by means of summary statistics. Continuous data were presented as the number of observations, mean, standard deviation (SD), minimum, 25th percentile (Q1), median, 75th percentile (Q3), and maximum. Categorical data were presented as counts and percentages. The data were presented for each treatment group and additionally by visit (if applicable). An overall summary across treatment groups was also included for descriptive summaries.
    End point type
    Primary
    End point timeframe
    Baseline to week 8
    End point values
    		 Lucentis Xlucane
    Number of subjects analysed
    289 [1]
    292
    Units: BCVA Letter Score (Letters)
        median (inter-quartile range (Q1-Q3))
    70 (62 to 77)
    68 (59 to 75.5)
    Notes
    [1] - 290 patients randomized to the Lucentis arm. 1 patient randomized never treated.
    Statistical analysis title
    		 Mixed model for repeated measures (MMRM)
    Comparison groups
    Lucentis v Xlucane
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.009 [2]
    Method
    		 t-test, 2-sided
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [2] - To prove the products to be biosimilar, the CI (90% for United States, 95% for the rest of the world) for the LS means difference had to be within the equivalence margin of +/- 3.5 letters.

    Secondary: Change in BCVA letters at Week 52 compared to baseline using the ETDRS protocol

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    End point title
    		 Change in BCVA letters at Week 52 compared to baseline using the ETDRS protocol
    End point description
    All statistical analyses were performed using SAS® version 9.4. In general, data were summarised by means of summary statistics. Continuous data were presented as the number of observations, mean, standard deviation (SD), minimum, 25th percentile (Q1), median, 75th percentile (Q3), and maximum. Categorical data were presented as counts and percentages. The data were presented for each treatment group and additionally by visit (if applicable). An overall summary across treatment groups was also included for descriptive summaries.
    End point type
    Secondary
    End point timeframe
    Baseline to week 52
    End point values
    		 Lucentis Xlucane
    Number of subjects analysed
    289 [3]
    292
    Units: BCVA letter score (Letters)
        median (inter-quartile range (Q1-Q3))
    73 (65 to 80)
    73 (60.5 to 79)
    Notes
    [3] - 290 patients randomized to the Lucentis arm. 1 patient randomized never treated
    Statistical analysis title
    		 Mixed model for repeated measures (MMRM)
    Statistical analysis description
    To prove the products to be biosimilar, the CI (90% for United States, 95% for the rest of the world) for the LS means difference had to be within the equivalence margin of +/- 3.5 letters.
    Comparison groups
    Lucentis v Xlucane
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.183
    Method
    		 t-test, 2-sided
    Confidence interval
    Variability estimate
    Standard deviation

    Secondary: Change in Central Foveal Thickness (CFT) week 8 compared to baseline measured by OCT

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    End point title
    		 Change in Central Foveal Thickness (CFT) week 8 compared to baseline measured by OCT
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Lucentis Xlucane
    Number of subjects analysed
    289 [4]
    292
    Units: μm
        median (inter-quartile range (Q1-Q3))
    -89 (-163 to -40)
    -81 (-145 to -36)
    Notes
    [4] - 290 patients randomized to the Lucentis arm. 1 patient randomized never treated
    Statistical analysis title
    		 Mixed model for repeated measures (MMRM)
    Comparison groups
    Lucentis v Xlucane
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.828
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in Central Foveal Thickness (CFT) week 52 compared to baseline measured by OCT

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    End point title
    		 Change in Central Foveal Thickness (CFT) week 52 compared to baseline measured by OCT
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 52
    End point values
    		 Lucentis Xlucane
    Number of subjects analysed
    289 [5]
    292
    Units: μm
        median (inter-quartile range (Q1-Q3))
    -104 (-196 to -46)
    -84 (-150 to -34)
    Notes
    [5] - 290 patients randomized to the Lucentis arm. 1 patient randomized never treated
    Statistical analysis title
    		 Mixed model for repeated measures (MMRM)
    Comparison groups
    Lucentis v Xlucane
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.65
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs occuring during the study, from time of inform consent to 28 days (+/- 5 days) or receiving last dose of study drug, up to 53 weeks.
    Adverse event reporting additional description
    AEs (ocular or non-ocular) as well as injection site reactions were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Lucentis
    Reporting group description
    		 -

    Reporting group title
    Xlucane
    Reporting group description
    		 -

    Serious adverse events
    		 Lucentis Xlucane
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 290 (12.07%)
    33 / 292 (11.30%)
         number of deaths (all causes)
    3
    8
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkins disease
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulva cancer
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 292 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 292 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    3 / 292 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Artrial fibrilation
         subjects affected / exposed
    2 / 290 (0.69%)
    3 / 292 (1.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infraction
         subjects affected / exposed
    3 / 290 (1.03%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Endophthalmitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular vasospasm
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal pigment epithelial tear
         subjects affected / exposed
    1 / 290 (0.34%)
    2 / 292 (0.68%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colonic haematoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         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
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    End stage renal disease
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         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
    Athralgia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Appendiceal Abscess
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 290 (0.34%)
    5 / 292 (1.71%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 290 (0.34%)
    2 / 292 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 290 (0.00%)
    3 / 292 (1.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lucentis Xlucane
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 290 (11.38%)
    25 / 292 (8.56%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    17 / 290 (5.86%)
    10 / 292 (3.42%)
         occurrences all number
    19
    10
    Eye disorders
    Conjunctival Haemorrhage
         subjects affected / exposed
    16 / 290 (5.52%)
    15 / 292 (5.14%)
         occurrences all number
    22
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2019
    Amendment includes clarifications and updates for requests by US FDA. Addition of unmasked analysis of primary efficacy endpoint to monitor the progress of the study after all patients complete month 2 and clarification for the purpose of both the planned interim analysis. Clarification of inclusion criteria 1 and 5 and exclusion criterion 1.
    06 May 2020
    Clarifies the equivalence margin of +/- 3.5, as agreed with EMA/FDA. Updated PK substudy sample size, due to risk with Covid-19 exposure. Clarifies the aim of the unmasked analysis. Clarifies exclusion criteria 1, 5 and 6 Clarifies statistical analysis Clarification on the syringe provided with the IMP
    26 Nov 2020
    Clarification regarding maintenance of masking in connection to the interim analysis. Provision of BD needles and syringes, suspended until further notice.

    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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