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    Clinical Trial Results:
    An open-label, multi-center, 6-month extension study comparing the long-term efficacy and safety of Lucentis (Ranibizumab) intravitreal injections versus Ozurdex (Dexamethasone) intravitreal implant in patients with visual impairment due to macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who have completed the respective core study (CRFB002EDE17 or CRFB002EDE18) Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2011-005045-13
    Trial protocol
    		 DE  
    Global end of trial date
    07 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2018
    First version publication date
    07 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRFB002EDE20
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01580020
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111x, trialandresults.registries@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111x, trialandresults.registries@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
    07 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the ocular and non-ocular adverse events during the 6-months study period in patients treated with Lucentis (0.5 mg) vs. treated with Ozurdex®
    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
    09 May 2012
    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: 175
    Worldwide total number of subjects
    175
    EEA total number of subjects
    175
    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)
    83
    From 65 to 84 years
    90
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 140 patients with (BRVO) completed the core study CRFB002EDE17, and 127 patients with (CRVO) completed the core study CRFB002EDE18. 92 patients with BRVO and 83 patients with CRVO were enrolled into the extension study. A total of 175 patients (113 in the ranibizumab group and 62 in the dexamethasone group) were enrolled

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ranibizumab (BRVO)
    Arm description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    RFB002
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/0.05 ml solution injected intraviterally

    Arm title
    		 Dexamethasone (BRVO)
    Arm description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravitreal implant in applicator
    Routes of administration
    Intravitreal use
    Dosage and administration details
    intravitreal implant 700ug LAR, over 6 months

    Arm title
    		 Ranibizumab (CRVO)
    Arm description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    RFB002
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/0.05 ml solution injected intraviterally

    Arm title
    		 Dexamethasone (CRVO)
    Arm description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravitreal implant in applicator
    Routes of administration
    Intravitreal use
    Dosage and administration details
    intravitreal implant 700ug LAR, over 6 months

    Number of subjects in period 1
    		Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Started
    52
    40
    61
    22
    Completed
    51
    33
    57
    20
    Not completed
    1
    7
    4
    2
         Consent withdrawn by subject
    -
    1
    1
    -
         Adverse event, non-fatal
    1
    1
    1
    1
         Administrative Problems
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -
         Lack of efficacy
    -
    5
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ranibizumab (BRVO)
    Reporting group description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

    Reporting group title
    Dexamethasone (BRVO)
    Reporting group description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

    Reporting group title
    Ranibizumab (CRVO)
    Reporting group description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally

    Reporting group title
    Dexamethasone (CRVO)
    Reporting group description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

    Reporting group values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO) Total
    Number of subjects
    		 52 40 61 22 175
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 24 21 26 12 83
        From 65-84 years
    		 28 19 33 10 90
        85 years and over
    		 0 0 2 0 2
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.5 ± 9.7 64.6 ± 9.9 66.6 ± 10.1 61.1 ± 11 -
    Gender, Male/Female
    Units: Participants
        Male
    		 18 22 31 14 85
        Female
    		 34 18 30 8 90
    Subject analysis sets

    Subject analysis set title
    Ranibizumab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

    Subject analysis set title
    Dexamethasone
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

    Subject analysis sets values
    		 Ranibizumab Dexamethasone
    Number of subjects
    113
    62
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    50
    33
        From 65-84 years
    61
    29
        85 years and over
    2
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    65.6 ± 9.9
    63.3 ± 10.3
    Gender, Male/Female
    Units: Participants
        Male
    49
    36
        Female
    64
    26

    End points

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    End points reporting groups
    Reporting group title
    Ranibizumab (BRVO)
    Reporting group description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

    Reporting group title
    Dexamethasone (BRVO)
    Reporting group description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

    Reporting group title
    Ranibizumab (CRVO)
    Reporting group description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally

    Reporting group title
    Dexamethasone (CRVO)
    Reporting group description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

    Subject analysis set title
    Ranibizumab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

    Subject analysis set title
    Dexamethasone
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

    Primary: Number of participants with adverse events as a measure of safety and tolerability

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    End point title
    		 Number of participants with adverse events as a measure of safety and tolerability [1]
    End point description
    The number of participants who experienced Adverse events, serious AE and death
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this primary outcome measure is safety, only descriptive analysis performed for this outcome measure.
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    61
    22
    Units: Participants
        Adverse event
    35
    28
    45
    16
        Serious adverse event
    2
    3
    6
    1
        Death
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Raw mean Best Corrected Visual Acuity (BCVA) by treatment group

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    End point title
    		 Raw mean Best Corrected Visual Acuity (BCVA) by treatment group
    End point description
    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months and 12 months
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    60
    22
    Units: Letters read correctly
    arithmetic mean (standard deviation)
        Baseline
    56.8 ± 10
    58.3 ± 10.8
    53.8 ± 15.7
    53.2 ± 16.1
        Month 6
    77.9 ± 10.6
    69.2 ± 11.9
    72.6 ± 13.5
    64.1 ± 24
        Month 12
    79 ± 10.1
    70.6 ± 13.9
    72.6 ± 15.8
    66.6 ± 22.3
    No statistical analyses for this end point

    Secondary: Percentage of patients gaining / losing ≥ 15 / 10 / 5 letters at month 12 compared to baseline

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    End point title
    		 Percentage of patients gaining / losing ≥ 15 / 10 / 5 letters at month 12 compared to baseline
    End point description
    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline
    End point type
    Secondary
    End point timeframe
    12 month
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    60
    22
    Units: Percentage of participants
    number (not applicable)
        Gain≥15 letters
    80.8
    50
    58.3
    45.5
        Gain ≥10 letters
    88.5
    65
    75
    68.2
        Gain ≥5 letters
    100
    80
    86.7
    77.3
        Loss of ≥15 letters
    0
    7.5
    0
    4.5
        Loss of ≥10 letters
    0
    10
    0
    4.5
        Loss of ≥5 letters
    0
    10
    3.3
    4.5
    No statistical analyses for this end point

    Secondary: Change in central subfield thickness (CSRT) from baseline to month 12

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    End point title
    		 Change in central subfield thickness (CSRT) from baseline to month 12
    End point description
    High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
    End point type
    Secondary
    End point timeframe
    Baseline , Month 12
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    59
    22
    Units: um
        arithmetic mean (standard deviation)
    -288.1 ± 180.6
    -211.5 ± 199.3
    -374.6 ± 239.8
    -360.3 ± 260.2
    No statistical analyses for this end point

    Secondary: Change of Foveal Center Point thickness (FCPT) from baseline to month 12

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    End point title
    		 Change of Foveal Center Point thickness (FCPT) from baseline to month 12
    End point description
    FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    51
    39
    58
    21
    Units: um
        arithmetic mean (standard deviation)
    -341.8 ± 226.2
    -252.6 ± 197.9
    -439.4 ± 279.8
    -432.3 ± 245.8
    No statistical analyses for this end point

    Secondary: Change in mean Visual Function Questionnaire (VFQ-25)

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    End point title
    		 Change in mean Visual Function Questionnaire (VFQ-25)
    End point description
    The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 months
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    60
    22
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Overall Composite
    8.1 ± 10.6
    5.5 ± 11.3
    9.1 ± 15.5
    10 ± 15.9
        General Health
    -1.4 ± 15.2
    6.3 ± 18.6
    1.7 ± 18.9
    5.7 ± 20.3
        General Vision
    15 ± 16.7
    9.5 ± 16.3
    20 ± 17.7
    13.6 ± 23.4
        Ocular Pain
    5.3 ± 15.7
    5.3 ± 13.8
    4.2 ± 20.8
    3.4 ± 15
        Near Activities
    13.3 ± 18.9
    10.8 ± 20.6
    12.3 ± 20.5
    12.3 ± 23.2
        Distance Activities
    8.9 ± 17.5
    5.6 ± 15.3
    7.8 ± 18.3
    8.3 ± 23.4
        Social Functioning
    3.4 ± 16.8
    2.2 ± 12
    3.3 ± 16.7
    2.8 ± 21.1
        Mental Health
    10.2 ± 14.9
    2.9 ± 20.4
    10.7 ± 21.7
    15.1 ± 18.3
        Role Difficulties
    4.8 ± 26.8
    10.6 ± 20.5
    14.6 ± 29.9
    24.4 ± 27.8
        Dependency
    3.2 ± 9.2
    0.4 ± 16.6
    5.1 ± 16.7
    4.4 ± 12.8
        Driving (BRVO n=44,31) (CRVO n=42,16)
    11.7 ± 23.9
    4.8 ± 21.3
    14.2 ± 24.6
    17.7 ± 25.1
        Color Vision(BRVO n=52,39)
    0.5 ± 10.5
    1.9 ± 10.6
    0.4 ± 17.5
    -1.1 ± 14.4
        Peripheral Vision(BRVO n=51,40)
    10.3 ± 24.1
    6.9 ± 23.3
    11.7 ± 25
    14.8 ± 22.7
    No statistical analyses for this end point

    Secondary: Change in SF-36 summary scores

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    End point title
    		 Change in SF-36 summary scores
    End point description
    The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline, month 12
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    60
    22
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Physical Component(BRVO n=50,39) (CRVO n=58,20)
    1.6 ± 5
    0.2 ± 7
    -1.1 ± 8.2
    1.3 ± 7.2
        Mental Component (BRVO n=50,39) (CRVO n=58,20)
    3.3 ± 9.7
    2.1 ± 13.2
    2.1 ± 9.3
    2.4 ± 12.4
    No statistical analyses for this end point

    Secondary: Change in Euro Quality of Life Questionnaire (EQ-5D) VAS summary scores

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    End point title
    		 Change in Euro Quality of Life Questionnaire (EQ-5D) VAS summary scores
    End point description
    The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).
    End point type
    Secondary
    End point timeframe
    Baseline, month 12
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    58
    21
    Units: Score on a scale
        arithmetic mean (standard deviation)
    3.3 ± 15.2
    2.6 ± 16.9
    1.5 ± 16.4
    0.2 ± 20.4
    No statistical analyses for this end point

    Secondary: Time to the first retreatment of both treatment arms

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    End point title
    		 Time to the first retreatment of both treatment arms
    End point description
    Time to the first retreatment
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
    Number of subjects analysed
    52
    40
    61
    22
    Units: Days
        median (confidence interval 95%)
    37 (3 to 56)
    9999.9 (328 to 99999.99)
    62 (5 to 67)
    9999.9 (309 to 99999.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    BRVO- Ranibizumab
    Reporting group description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

    Reporting group title
    BRVO- Dexamethasone
    Reporting group description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required

    Reporting group title
    CRVO- Ranibizumab
    Reporting group description
    		 Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

    Reporting group title
    CRVO- Dexamethasone
    Reporting group description
    		 A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required

    Serious adverse events
    		 BRVO- Ranibizumab BRVO- Dexamethasone CRVO- Ranibizumab CRVO- Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 40 (7.50%)
    6 / 61 (9.84%)
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    SQUAMOUS CELL CARCINOMA OF SKIN
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    LUMBAR RADICULOPATHY
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    GLAUCOMA (Fellow eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GLAUCOMA (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    IRIS NEOVASCULARISATION (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MACULAR OEDEMA (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OCULAR ISCHAEMIC SYNDROME (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RETINAL DETACHMENT (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VISUAL ACUITY REDUCED (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VITREOUS HAEMORRHAGE (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    PSORIASIS
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    SUBSTANCE ABUSE
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 BRVO- Ranibizumab BRVO- Dexamethasone CRVO- Ranibizumab CRVO- Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 52 (67.31%)
    28 / 40 (70.00%)
    45 / 61 (73.77%)
    16 / 22 (72.73%)
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    INTRAOCULAR PRESSURE DECREASED (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    INTRAOCULAR PRESSURE INCREASED (Study eye)
         subjects affected / exposed
    3 / 52 (5.77%)
    10 / 40 (25.00%)
    3 / 61 (4.92%)
    4 / 22 (18.18%)
         occurrences all number
    4
    12
    8
    4
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 40 (5.00%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    2
    0
    0
    MUSCLE STRAIN
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    POST PROCEDURAL SWELLING (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    Congenital, familial and genetic disorders
    FACTOR V LEIDEN MUTATION
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 40 (5.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    2
    SCIATICA
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    2
    0
    TRIGEMINAL NEURALGIA
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    CHEST DISCOMFORT
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    PYREXIA
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    Eye disorders
    CATARACT (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 40 (7.50%)
    2 / 61 (3.28%)
    1 / 22 (4.55%)
         occurrences all number
    0
    3
    2
    1
    CONJUNCTIVAL HAEMORRHAGE (Study eye)
         subjects affected / exposed
    2 / 52 (3.85%)
    7 / 40 (17.50%)
    3 / 61 (4.92%)
    3 / 22 (13.64%)
         occurrences all number
    2
    9
    3
    3
    CONJUNCTIVAL HYPERAEMIA (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    CONJUNCTIVAL IRRITATION (Study eye)
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 40 (5.00%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    3
    0
    0
    CONJUNCTIVITIS ALLERGIC (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    DRY EYE (Fellow eye)
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    DRY EYE (Study eye)
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    1
    0
    0
    EYE PAIN (Study eye)
         subjects affected / exposed
    4 / 52 (7.69%)
    0 / 40 (0.00%)
    7 / 61 (11.48%)
    4 / 22 (18.18%)
         occurrences all number
    5
    0
    11
    4
    FOREIGN BODY SENSATION IN EYES (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    4 / 61 (6.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    5
    0
    GLAUCOMA (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    1
    LACRIMATION INCREASED (Study eye)
         subjects affected / exposed
    6 / 52 (11.54%)
    2 / 40 (5.00%)
    2 / 61 (3.28%)
    2 / 22 (9.09%)
         occurrences all number
    6
    3
    2
    2
    MACULAR FIBROSIS (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    MACULAR OEDEMA (Study eye)
         subjects affected / exposed
    9 / 52 (17.31%)
    3 / 40 (7.50%)
    14 / 61 (22.95%)
    3 / 22 (13.64%)
         occurrences all number
    13
    3
    15
    3
    OCULAR DISCOMFORT (Study eye)
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 40 (10.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences all number
    2
    4
    1
    0
    OCULAR HYPERAEMIA (Study eye)
         subjects affected / exposed
    7 / 52 (13.46%)
    3 / 40 (7.50%)
    4 / 61 (6.56%)
    3 / 22 (13.64%)
         occurrences all number
    8
    4
    6
    4
    PHOTOPSIA (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    RETINAL EXUDATES (Study eye)
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    RETINAL ISCHAEMIA (Study eye)
         subjects affected / exposed
    5 / 52 (9.62%)
    4 / 40 (10.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    5
    4
    2
    0
    RETINAL OEDEMA (Study eye)
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    VISION BLURRED (Study eye)
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    4 / 61 (6.56%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    4
    1
    VISUAL ACUITY REDUCED (Study eye)
         subjects affected / exposed
    4 / 52 (7.69%)
    4 / 40 (10.00%)
    8 / 61 (13.11%)
    1 / 22 (4.55%)
         occurrences all number
    5
    4
    9
    1
    VISUAL IMPAIRMENT (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    VITREOUS DETACHMENT (Fellow eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 40 (5.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    0
    VITREOUS DETACHMENT (Study eye)
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 40 (5.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    1
    GASTRITIS
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    2 / 61 (3.28%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 40 (2.50%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences all number
    3
    1
    1
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 40 (2.50%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences all number
    4
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 40 (5.00%)
    6 / 61 (9.84%)
    1 / 22 (4.55%)
         occurrences all number
    3
    2
    6
    1
    OSTEOARTHRITIS
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    SJOGREN'S SYNDROME
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 40 (5.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    2
    0
    CONJUNCTIVITIS (Study eye)
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 40 (2.50%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    CYSTITIS
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    GASTROINTESTINAL INFECTION
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    2 / 61 (3.28%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    HERPES ZOSTER
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    INFLUENZA
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 40 (2.50%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 52 (17.31%)
    3 / 40 (7.50%)
    12 / 61 (19.67%)
    3 / 22 (13.64%)
         occurrences all number
    12
    3
    15
    4
    PERIODONTITIS
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    1
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    RHINITIS
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    SINUSITIS
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 40 (0.00%)
    1 / 61 (1.64%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Metabolism and nutrition disorders
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 40 (0.00%)
    0 / 61 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    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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