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    Clinical Trial Results:
    A 52-week, two arm, randomized, open-label, multicenter study assessing the efficacy and safety of two different brolucizumab 6 mg dosing regimens for patients with suboptimal anatomically controlled neovascular age-related macular degeneration (FALCON)

    Summary
    EudraCT number
    		 2019-004767-53
    Trial protocol
    		 DE  
    Global end of trial date
    31 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2025
    First version publication date
    01 Jan 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CRTH258ADE01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04679935
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.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
    31 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective was to evaluate the difference in BCVA change from baseline for brolucizumab 6 mg with one (initial) injection followed by treatment every 12 weeks as compared to brolucizumab 6 mg with three monthly loading injections followed by treatment every 12 weeks.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jul 2021
    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
    Germany: 47
    Country: Number of subjects enrolled
    Switzerland: 5
    Worldwide total number of subjects
    52
    EEA total number of subjects
    47
    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)
    3
    From 65 to 84 years
    40
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 If both eyes were eligible as per the inclusion and exclusion criteria, the eye with the worse visual acuity should have been selected for study eye, unless the investigator deemed it more appropriate to select the eye with better visual acuity, based on medical reasons or local ethical requirements.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Brolucizumab 6 mg loading
    Arm description
    		 3 x 4-weekly initial injections followed by an injection every 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brolucizumab
    Investigational medicinal product code
    RTH258
    Other name
    Beovu
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Brolucizumab 6 mg loading

    Arm title
    		 Brolucizumab 6 mg non-loading
    Arm description
    		 One initial injection followed by treatment every 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brolucizumab
    Investigational medicinal product code
    RTH258
    Other name
    Beovu
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Brolucizumab 6 mg non-loading

    Number of subjects in period 1
    		Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Started
    25
    27
    Completed
    25
    26
    Not completed
    0
    1
         Adverse event, serious fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brolucizumab 6 mg loading
    Reporting group description
    		 3 x 4-weekly initial injections followed by an injection every 12 weeks

    Reporting group title
    Brolucizumab 6 mg non-loading
    Reporting group description
    		 One initial injection followed by treatment every 12 weeks

    Reporting group values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading Total
    Number of subjects
    		 25 27 52
    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)
    		 0 3 3
        From 65-84 years
    		 21 19 40
        85 years and over
    		 4 5 9
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 77.6 ( 6.3 ) 77.4 ( 8.3 ) -
    Sex: Female, Male
    Units:
        Female
    		 14 18 32
        Male
    		 11 9 20
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 25 27 52
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Brolucizumab 6 mg loading
    Reporting group description
    		 3 x 4-weekly initial injections followed by an injection every 12 weeks

    Reporting group title
    Brolucizumab 6 mg non-loading
    Reporting group description
    		 One initial injection followed by treatment every 12 weeks

    Primary: Week 40 to Week 52: LS mean change from baseline in best corrected visual acuity (BCVA) in the study eye

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    End point title
    		 Week 40 to Week 52: LS mean change from baseline in best corrected visual acuity (BCVA) in the study eye
    End point description
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
    End point type
    Primary
    End point timeframe
    Baseline, Week 40 to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    26
    Units: Letters read
    least squares mean (standard error)
        Week 40
    3.24 ( 1.32 )
    -0.50 ( 1.28 )
        Week 44
    3.88 ( 1.66 )
    -0.27 ( 1.60 )
        Week 48
    3.12 ( 1.71 )
    -2.23 ( 1.65 )
        Week 52
    2.76 ( 1.64 )
    -1.43 ( 1.58 )
    Statistical analysis title
    		 Brolucizumab loading v Brolucizumab non-loading
    Statistical analysis description
    Week 44
    Comparison groups
    Brolucizumab 6 mg loading v Brolucizumab 6 mg non-loading
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    		 MMRM model
    Parameter type
    		 Difference
    Point estimate
    -4.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.78
         upper limit
    		 -0.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3
    Notes
    [1] - Analysis was purely descriptive.
    Statistical analysis title
    		 Brolucizumab loading v Brolucizumab non-loading
    Statistical analysis description
    Week 40
    Comparison groups
    Brolucizumab 6 mg loading v Brolucizumab 6 mg non-loading
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    		 MMRM model
    Parameter type
    		 Difference
    Point estimate
    -3.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.47
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.84
    Notes
    [2] - Analysis was purely descriptive.
    Statistical analysis title
    		 Brolucizumab loading v Brolucizumab non-loading
    Statistical analysis description
    Week 52
    Comparison groups
    Brolucizumab 6 mg loading v Brolucizumab 6 mg non-loading
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    		 MMRM model
    Parameter type
    		 Difference
    Point estimate
    -4.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.77
         upper limit
    		 0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.28
    Notes
    [3] - Analysis was purely descriptive.
    Statistical analysis title
    		 Brolucizumab loading v Brolucizumab non-loading
    Statistical analysis description
    Mean of Week 40 to Week 52
    Comparison groups
    Brolucizumab 6 mg loading v Brolucizumab 6 mg non-loading
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    		 MMRM model
    Parameter type
    		 Difference
    Point estimate
    -4.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.56
         upper limit
    		 -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.09
    Notes
    [4] - Analysis was purely descriptive.
    Statistical analysis title
    		 Brolucizumab loading v Brolucizumab non-loading
    Statistical analysis description
    Week 48
    Comparison groups
    Brolucizumab 6 mg loading v Brolucizumab 6 mg non-loading
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    		 MMRM model
    Parameter type
    		 Difference
    Point estimate
    -5.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.13
         upper limit
    		 -0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.38
    Notes
    [5] - Analysis was purely descriptive.

    Secondary: Treatment intervals before and during the study

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    End point title
    		 Treatment intervals before and during the study
    End point description
    Treatment interval distribution. Treatment interval during the study, within 24 weeks prior to baseline and interval between the last 2 injections in the study. In the loading arm, data from the loading period was excluded.
    End point type
    Secondary
    End point timeframe
    -24 Weeks, Baseline, Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: days
    median (full range (min-max))
        within 24 weeks prior to baseline
    54.7 (40.0 to 152.0)
    68.5 (37.2 to 165.0)
        from baseline to week 52 (n=23,25)
    64.8 (47.5 to 85.3)
    77.8 (55.8 to 85.8)
        Last treatment interval during the study (n=25,25)
    56.0 (28.0 to 88.0)
    65.0 (56.0 to 91.0)
    No statistical analyses for this end point

    Secondary: Number of patients with prolonged interval

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    End point title
    		 Number of patients with prolonged interval
    End point description
    Treatment interval distribution. Prolongation was calculated by comparing the mean treatment interval in last 24 weeks prior to first brolucizumab injection (a) with the mean of the average treatment interval during the study (loading phase excluded in the loading arm) and (b) with the last treatment interval during the study. Patients with only 1 injection during the treatment period were calculated as non-responders (no prolon­gation).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        from baseline to week 52
    18
    12
        Last treatment interval during the study
    13
    10
    No statistical analyses for this end point

    Secondary: Proportion of patients who maintained on q12w regimen.

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    End point title
    		 Proportion of patients who maintained on q12w regimen.
    End point description
    Treatment interval distribution up to Week 52. Proportion of patients maintained on q12w treatment frequency in the two brolucizumab groups up to week 52. Patients who discontinued treatment before week 52 were rated as non-responders, i.e., as patients who did not maintain the q12w regimen. In the loading arm, the loading period up to week 12 was not considered in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
    8
    6
    No statistical analyses for this end point

    Secondary: Mean change in best-corrected visual acuity

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    End point title
    		 Mean change in best-corrected visual acuity
    End point description
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 16 to 28, Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Letters read
    arithmetic mean (standard deviation)
        Baseline
    72.0 ( 8.7 )
    71.6 ( 11.5 )
        Mean of weeks 16 to 28
    74.9 ( 9.2 )
    71.2 ( 12.9 )
        Week 52
    74.8 ( 9.1 )
    69.8 ( 16.1 )
    No statistical analyses for this end point

    Secondary: Distribution of patients at every 8 weeks / every 12 weeks intervals - Frequency of switches in treatment intervals between baseline and week 52

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    End point title
    		 Distribution of patients at every 8 weeks / every 12 weeks intervals - Frequency of switches in treatment intervals between baseline and week 52
    End point description
    Treatment interval distribution
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Switch q12w to q8w (overall)
    15
    19
        Switch q8w to q12w (overall)
    3
    6
    No statistical analyses for this end point

    Secondary: LS mean change in best-corrected visual acuity from Baseline at Week 52

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    End point title
    		 LS mean change in best-corrected visual acuity from Baseline at Week 52
    End point description
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    26
    Units: Letters read
        least squares mean (standard error)
    2.76 ( 1.64 )
    -1.43 ( 1.58 )
    Statistical analysis title
    		 Brolucizumab loading v Brolucizumab non-loading
    Statistical analysis description
    Week 52
    Comparison groups
    Brolucizumab 6 mg loading v Brolucizumab 6 mg non-loading
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    		 MMRM model
    Parameter type
    		 Difference
    Point estimate
    -4.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.77
         upper limit
    		 -0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.28
    Notes
    [6] - Analysis was purely descriptive.

    Secondary: Number of patients with best-corrected visual acuity >= 69 letters

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    End point title
    		 Number of patients with best-corrected visual acuity >= 69 letters
    End point description
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, up to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
    20
    19
    No statistical analyses for this end point

    Secondary: Number of patients with best-corrected visual acuity improvements of >= 5, >= 10 and >= 15 letters

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    End point title
    		 Number of patients with best-corrected visual acuity improvements of >= 5, >= 10 and >= 15 letters
    End point description
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, up to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        BCVA ≥ 5 ETDRS letters improvement during study
    9
    5
        BCVA ≥ 10 ETDRS letters improvement during study
    2
    2
        BCVA ≥ 15 ETDRS letters improvement during study
    1
    0
    No statistical analyses for this end point

    Secondary: Change in central subfield thickness from Baseline at Weeks 12, 16, 28 and 52

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    End point title
    		 Change in central subfield thickness from Baseline at Weeks 12, 16, 28 and 52
    End point description
    Change in central subfield thickness was measured by Spectral domain optical coherence tomography.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28 and 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: µm
    median (full range (min-max))
        Week 12
    -74.0 (-275 to 27)
    -8.5 (-232 to 650)
        Week 16
    -20.0 (-240 to 208)
    -51.0 (-317 to 80)
        Week 28
    -21.0 (-273 to 393)
    -53.0 (-357 to 60)
        Week 52
    -15.0 (-268 to 269)
    -49.5 (-359 to 30)
    No statistical analyses for this end point

    Secondary: Absence of intraretinal fluid in the central subfield

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    End point title
    		 Absence of intraretinal fluid in the central subfield
    End point description
    Change in fluids was measured by Spectral domain optical coherence tomography.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks from baseline up to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Baseline
    13
    16
        Week 4
    19
    22
        Week 8
    17
    16
        Week 12
    21
    16
        Week 16
    12
    21
        Week 20
    16
    20
        Week 24
    17
    18
        Week 28
    16
    20
        Week 32
    18
    17
        Week 36
    17
    17
        Week 40
    16
    21
        Week 44
    16
    19
        Week 48
    19
    19
        Week 52
    16
    21
    No statistical analyses for this end point

    Secondary: Absence of subretinal fluid in the central subfield

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    End point title
    		 Absence of subretinal fluid in the central subfield
    End point description
    Change in fluids was measured by Spectral domain optical coherence tomography.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks from baseline up to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Baseline
    5
    6
        Week 4
    13
    18
        Week 8
    18
    12
        Week 12
    20
    6
        Week 16
    8
    15
        Week 20
    3
    12
        Week 24
    13
    12
        Week 28
    9
    13
        Week 32
    11
    14
        Week 36
    11
    14
        Week 40
    10
    15
        Week 44
    8
    10
        Week 48
    10
    15
        Week 52
    9
    16
    No statistical analyses for this end point

    Secondary: Absence of sub-retinal pigment epithelium fluid in the central subfield

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    End point title
    		 Absence of sub-retinal pigment epithelium fluid in the central subfield
    End point description
    Change in fluids was measured by Spectral domain optical coherence tomography.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks from baseline up to Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Baseline
    15
    13
        Week 4
    20
    21
        Week 8
    18
    16
        Week 12
    20
    17
        Week 16
    20
    14
        Week 20
    17
    16
        Week 24
    18
    16
        Week 28
    19
    21
        Week 32
    19
    20
        Week 36
    18
    19
        Week 40
    22
    18
        Week 44
    18
    18
        Week 48
    21
    18
        Week 52
    17
    16
    No statistical analyses for this end point

    Secondary: Presence of active choroidal neovascularization leakage

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    End point title
    		 Presence of active choroidal neovascularization leakage
    End point description
    Presence of active choroidal neovascularization leakage was measured by Fluorescein angiography. CNV = choroidal neovascularization; MNV = macular neovascularization; Wk = Week
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Active CNV leakage at week 52 - Yes
    17
    15
        Active CNV leakage at week 52 - No
    7
    10
        Active CNV leakage at week 52 - missing
    1
    2
        CNV location at week 52 - Subfoveal
    11
    10
        CNV location at week 52 - Extrafoveal
    6
    5
        CNV location at week 52 - Not applicable
    7
    10
        CNV location at week 52 - Missing
    1
    2
        CNV subtype at week 52 - Type 1 MNV
    12
    9
        CNV subtype at Wk 52 - Mixed type 1 and type 2 MNV
    2
    1
        CNV subtype at week 52 -Type 3 MNV
    3
    5
        CNV subtype- Wk 52 - Not applicable
    7
    10
        CNV subtype at week 52 - Missing
    1
    2
    No statistical analyses for this end point

    Secondary: Overview of TEAEs

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    End point title
    		 Overview of TEAEs
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. Disc. = discontinuation
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Any AE
    23
    26
        Ocular AE(s) in the study eye
    17
    19
        Ocular AE(s) in the fellow eye
    4
    9
        Non-ocular AE(s)
    20
    19
        AE(s) related to injection procedure
    11
    12
        AE(s) related to study drug
    9
    12
        SAE(s)
    5
    6
        Ocular SAE(s) in the study eye
    1
    4
        Non-ocular SAE(s)
    4
    2
        Death
    0
    1
        Non-fatal SAE(s)
    5
    6
        Disc.of study treatment due to any AE(s)
    2
    5
        Disc.of study treatment due to non-serious AE(s)
    0
    4
        Disc.of study treatment due to any SAE(s)
    2
    2
    No statistical analyses for this end point

    Secondary: Ocular TEAEs in the study eye by primary system organ class

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    End point title
    		 Ocular TEAEs in the study eye by primary system organ class
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. Adm. = administration
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Total
    17
    19
        Eye disorders
    16
    17
        General disorders and adm. site conditions
    0
    1
        Infections and infestations
    2
    2
        Injury, poisoning and procedural complications
    2
    1
        Investigations
    2
    4
    No statistical analyses for this end point

    Secondary: Ocular TEAEs in the study eye by preferred term (at least 5% in any group)

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    End point title
    		 Ocular TEAEs in the study eye by preferred term (at least 5% in any group)
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Conjunctival haemorrhage
    7
    5
        Visual acuity reduced
    2
    3
        Eye inflammation
    1
    3
        Intraocular pressure increased
    1
    3
        Retinal oedema
    1
    3
        Dry Eye
    1
    2
        Neovascular age-related macular degeneration
    1
    2
        Vitreous detachment
    2
    1
        Cataract
    0
    2
        Conjunctivitis
    0
    2
        Retinal exudates
    0
    2
        Vitreous floaters
    0
    2
    No statistical analyses for this end point

    Secondary: Non-ocular TEAEs - total

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    End point title
    		 Non-ocular TEAEs - total
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
    20
    19
    No statistical analyses for this end point

    Secondary: Ocular TEAEs in the study eye of moderate or severe intensity

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    End point title
    		 Ocular TEAEs in the study eye of moderate or severe intensity
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. MD = macular degeneration int. = intensity
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        Any AE of moderate intensity
    3
    8
        Cataract - moderate intensity
    0
    2
        Conjunctival haemorrhage - moderate intensity
    0
    1
        Conjunctival irritation - moderate intensity
    1
    0
        Conjunctivitis allergic - moderate intensity
    0
    1
        Dry eye - moderate intensity
    1
    1
        Eye inflammation - moderate intensity
    0
    1
        Eye pain - moderate intensity
    0
    1
        Neovascular age-related MD - moderate intensity
    0
    1
        Retinal vasculitis - moderate intensity
    0
    2
        Subretinal fluid - moderate intensity
    0
    1
        Visual acuity reduced - moderate intensity
    1
    0
        Vital dye staining cornea present-moderate int.
    0
    1
        Vitreous opacities - moderate intensity
    0
    1
        Any AE of severe intensity
    1
    2
        Endophthalmitis - severe intensity
    1
    0
        Eye inflammation - severe intensity
    1
    1
        Intraocular pressure increased - severe intensity
    0
    1
        Retinal haemorrhage - severe intensity
    0
    1
        Retinal neovascularization - severe intensity
    0
    1
        Visual acuity reduced - severe intensity
    0
    1
    No statistical analyses for this end point

    Post-hoc: All collected deaths

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    End point title
    		 All collected deaths
    End point description
    On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 30 days after last treatment, up to a maximum timeframe of approximately 52 weeks. Post-treatment death data are reported from day 31 after last treatment to end of study (Week 52).
    End point type
    Post-hoc
    End point timeframe
    Fatality data are reported from first dose of study treatment until approximately Week 52.
    End point values
    		 Brolucizumab 6 mg loading Brolucizumab 6 mg non-loading
    Number of subjects analysed
    25
    27
    Units: Participants
        On-treatment Deaths
    0
    0
        Post-treatment Deaths
    0
    1
        Total Deaths
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Non-Loading Arm
    Reporting group description
    		 Non-Loading Arm

    Reporting group title
    Loading Arm
    Reporting group description
    		 Loading Arm

    Serious adverse events
    		 Non-Loading Arm Loading Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 27 (22.22%)
    5 / 25 (20.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chromophobe renal cell carcinoma
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Intraocular pressure increased- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ballismus
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         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
    Pyrexia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye inflammation- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iridocyclitis- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal neovascularisation- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vasculitis- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Endophthalmitis- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Non-Loading Arm Loading Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 27 (96.30%)
    23 / 25 (92.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Blepharal papilloma- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    3 / 27 (11.11%)
    3 / 25 (12.00%)
         occurrences all number
    3
    3
    Hypertensive crisis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Application site wound
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Retention cyst- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Injection site pain- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Intraocular pressure increased- Study Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    6
    1
    Vital dye staining cornea present- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Intraocular pressure increased- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Stress fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Meniscus injury
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Contusion
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Bone contusion
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Arthropod sting
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Epicondylitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Intra-ocular injection complication- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Intra-ocular injection complication- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Expired product administered- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Eye disorders
    Retinopathy hypertensive
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Corneal erosion- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Detachment of retinal pigment epithelium- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eczema eyelids- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eczema eyelids- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Episcleritis- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye inflammation- Study Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Eye irritation- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Anterior chamber cell- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Cataract- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Chalazion- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Conjunctival haemorrhage- Study Eye
         subjects affected / exposed
    5 / 27 (18.52%)
    7 / 25 (28.00%)
         occurrences all number
    5
    7
    Conjunctival hyperaemia- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Conjunctival irritation- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Corneal epithelial microcysts- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye pain- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye ulcer- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Vitreous opacities- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Vitreous haemorrhage- Fellow Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Vitreous floaters- Study Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Vitreous detachment- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Vitreal cells- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced- Study Eye
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 25 (4.00%)
         occurrences all number
    3
    2
    Visual acuity reduced- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Vision blurred- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Subretinal fluid- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    2
    Subretinal fluid- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    3
    2
    Subretinal fibrosis- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Scleritis- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Retinal vasculitis- Study Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Retinal oedema- Study Eye
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 25 (4.00%)
         occurrences all number
    4
    2
    Retinal oedema- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Retinal haemorrhage- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    2
    Retinal exudates- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Retinal cyst- Fellow Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Foreign body sensation in eyes- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Macular oedema- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Macular oedema- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Neovascular age-related macular degeneration- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 25 (12.00%)
         occurrences all number
    1
    3
    Neovascular age-related macular degeneration- Study Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Ocular hyperaemia- Fellow Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Posterior capsule opacification- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Retinal aneurysm- Fellow Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Retinal aneurysm- Study Eye
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Vitreous floaters- Bilateral
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced- Bilateral
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Retinal exudates- Bilateral
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye inflammation- Bilateral
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Dry eye- Bilateral
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Conjunctivitis allergic- Bilateral
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Cataract- Bilateral
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Blepharitis- Bilateral
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Tooth impacted
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Palmar erythema
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Incontinence
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Synovial cyst
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Muscle tightness
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Jaw cyst
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    3
    1
    Arthritis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    2
    Bronchitis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Sialoadenitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Oral herpes
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 27 (18.52%)
    6 / 25 (24.00%)
         occurrences all number
    5
    6
    Lyme disease
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Herpes virus infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    3
    1
    COVID-19
         subjects affected / exposed
    5 / 27 (18.52%)
    6 / 25 (24.00%)
         occurrences all number
    5
    6
    Hordeolum- Study Eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Conjunctivitis- Study Eye
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2021
    (1) Implementation of the Urgent Safety Measures (USM) described in the 10-Aug-2021 Dear Investigator Letter into the study protocol. The USM were implemented for ongoing studies not achieving Last Patient Last Visit (LPLV) by 11-Aug-2021 and in response to the identification of a causal immune-mediated mechanism of the previously identified risk of retinal vasculitis, and/or retinal vascular occlusion, typically in the presence of intraocular inflammation.

    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
    For support, Contact us.
    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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