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    Clinical Trial Results:
    Treatment of macular edema due to central retinal vein occlusion with ranibizumab (Lucentis®).

    Summary
    EudraCT number
    		 2009-017782-30
    Trial protocol
    		 AT  
    Global end of trial date
    15 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2018
    First version publication date
    20 Dec 2018
    Other versions
    Summary report(s)
    		 Summary attachment

    Trial information

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    Trial identification
    Sponsor protocol code
    Lucentis in CRVO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Graz
    Sponsor organisation address
    Auenbruggerplatz 4, Graz, Austria, 8036
    Public contact
    Weger, Martin, Ao.Univ.-Prof. Dr.med.univ., Medizinische Universität Graz, 0043 385-14086, martin.weger@medunigraz.at
    Scientific contact
    Weger, Martin, Ao.Univ.-Prof. Dr.med.univ., Medizinische Universität Graz, 0043 385-14086, martin.weger@medunigraz.at
    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
    13 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Explore whether intravitreal ranibizumab is an effective, safe and convenient treatment for patients with macular edema due to central retinal vein occlusion. Aim of the study is to increase the visual acuity by 15 EDTRS letters in 50% of the patients.
    Protection of trial subjects
    Measures taken to minimize the risk of potential adverse events associated with serial intraocular injections included e.g. aseptic technique, anesthesia, drug preparation and administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    12
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment target as defined in the protocol was achieved (20 patients).

    Pre-assignment
    Screening details
    		 There have been no screening failures in the course of the study.

    Period 1
    Period 1 title
    Baseline to first injection
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 intravitreal ranibizumab injections
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumamb
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Enrolled patients received one intravitreal injection of 0.5 mg ranibizumab (month 0). At month 1 and 2 patients received an additional intravitreal injection of 0.5 mg ranibizumab. Follow-up was performed at a monthly basis for a total of 12 months. After month 2 additional ranibizumab injections have been administered, if there was(1) a loss of 5 EDTRS letters accompanied by fluid in the macula as detected by OCT, or (2) persistent macular edema, or (3) an increase in central retinal thickness as detected by OCT. During the 12-month study period a maximum of 12 intravitreal ranibizumab injections were administered.

    Number of subjects in period 1
    		intravitreal ranibizumab injections
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    First injection to complete follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 intravitreal ranibizumab injections
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumamb
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Enrolled patients received one intravitreal injection of 0.5 mg ranibizumab (month 0). At month 1 and 2 patients received an additional intravitreal injection of 0.5 mg ranibizumab. Follow-up was performed at a monthly basis for a total of 12 months. After month 2 additional ranibizumab injections have been administered, if there was(1) a loss of 5 EDTRS letters accompanied by fluid in the macula as detected by OCT, or (2) persistent macular edema, or (3) an increase in central retinal thickness as detected by OCT. During the 12-month study period a maximum of 12 intravitreal ranibizumab injections were administered.

    Number of subjects in period 2
    		intravitreal ranibizumab injections
    Started
    20
    Completed
    19
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline to first injection
    Reporting group description
    		 -

    Reporting group values
    		 Baseline to first injection Total
    Number of subjects
    		 20 20
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        30-45 years
    		 2 2
        46-55 years
    		 3 3
        56-65 years
    		 7 7
        66-75 years
    		 2 2
        76-85
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 11 11
    Subject analysis sets

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For the quantitative analysis, only patients with complete follow-up were included. Patients with incomplete follow-up and screening failure were excluded.

    Subject analysis set title
    End data- patients after complete follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For the quantitative analysis, only patients with complete follow-up were included. Patients with incomplete follow-up and screening failure were excluded.

    Subject analysis sets values
    		 Baseline End data- patients after complete follow-up
    Number of subjects
    20
    19
    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)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
        30-45 years
    2
    2
        46-55 years
    3
    3
        56-65 years
    7
    7
        66-75 years
    2
    2
        76-85
    5
    4
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    9
    8
        Male
    11
    11

    End points

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    End points reporting groups
    Reporting group title
    intravitreal ranibizumab injections
    Reporting group description
    		 -
    Reporting group title
    intravitreal ranibizumab injections
    Reporting group description
    		 -

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For the quantitative analysis, only patients with complete follow-up were included. Patients with incomplete follow-up and screening failure were excluded.

    Subject analysis set title
    End data- patients after complete follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For the quantitative analysis, only patients with complete follow-up were included. Patients with incomplete follow-up and screening failure were excluded.

    Primary: Efficacy - increase of visual acuity by 15 EDTRS letters

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    End point title
    		 Efficacy - increase of visual acuity by 15 EDTRS letters
    End point description
    Fifteen of the 19 patients (79%) gained 15 EDTRS letters or more after intravitreal injections of ranibizumab after twelve months
    End point type
    Primary
    End point timeframe
    12 months after first treatment
    End point values
    		 intravitreal ranibizumab injections Baseline End data- patients after complete follow-up
    Number of subjects analysed
    20 [1]
    20 [2]
    19 [3]
    Units: letters
    20
    20
    19
    Notes
    [1] - 20 patients received intravitreal ranibizumab injections
    [2] - 20
    [3] - 19
    Statistical analysis title
    		 Efficacy
    Comparison groups
    Baseline v End data- patients after complete follow-up
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 ≤ 5
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [4] - All statistical analyses have been performed using STATA 13 (StataCorp LP, USA). Mean changes were evaluated using spearman’s correlation and t-test. P-values of 0.05 were considered significant.

    Secondary: Proportion of patients who gain 15 letters of BCVA

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    End point title
    		 Proportion of patients who gain 15 letters of BCVA
    End point description
    Fifteen of the 19 patients (63%) gained 15 letters of BCVA or more after intravitreal injections of ranibizumab using a pro re nata approach after six months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: letters
    20
    19
    No statistical analyses for this end point

    Secondary: patients who lose less than 15 letters of BCVA

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    End point title
    		 patients who lose less than 15 letters of BCVA
    End point description
    17 of the 19 patients (89%) lost less than 15 letters of BCVA from baseline at month 6 and all patients (100%) lost less than 15 letters of BCVA at month 12.
    End point type
    Secondary
    End point timeframe
    6 and 12 months after first treatment
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: letters
    20
    19
    No statistical analyses for this end point

    Secondary: Mean change in central retinal thickness

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    End point title
    		 Mean change in central retinal thickness
    End point description
    Mean central retinal thickness decreased from 701μm at baseline to 389μm at month 6 (p<0.01) and to 348μm at month 12 (p<0.01).
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12 after first treatment
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: μm
        number (not applicable)
    20
    19
    No statistical analyses for this end point

    Secondary: Mean change in contrast sensitivity

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    End point title
    		 Mean change in contrast sensitivity
    End point description
    Contrast sensitivity increased in the study eye from 0.91 at baseline to 1.33 at month 6 (p<0.01) and 1.41 at month 12 (p<0.01) .
    End point type
    Secondary
    End point timeframe
    Months 6 and 12 after first treatment
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: letters
    20
    19
    No statistical analyses for this end point

    Secondary: Mean number of ranibizumab injections needed for resolution of macular edema

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    End point title
    		 Mean number of ranibizumab injections needed for resolution of macular edema
    End point description
    Patients received on average 7.2 injections (SD 3.1) within one-year. Seventeen of the 19 patients showed complete resolution
    End point type
    Secondary
    End point timeframe
    12 months after first treatment
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: Number of injections
    20
    19
    No statistical analyses for this end point

    Secondary: Mean number in reading speed

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    End point title
    		 Mean number in reading speed
    End point description
    Reading speed increased in the study eye from 39.3 wpm (words per minute) at baseline to 77 wpm at month 6 (p<0.01) and 88.4 wpm at month 12 (p<0.01) .
    End point type
    Secondary
    End point timeframe
    Months 6 and 12 after first treatment
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: number of words per minute
    20
    19
    No statistical analyses for this end point

    Secondary: Mean change in arterio-venous passage time

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    End point title
    		 Mean change in arterio-venous passage time
    End point description
    Due to impaired assessability of the fluorescein angiography images this secondary variable was not analysed
    End point type
    Secondary
    End point timeframe
    6 and 12 month from baseline
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: seconds
    20
    19
    No statistical analyses for this end point

    Secondary: Mean change in quality of life scores

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    End point title
    		 Mean change in quality of life scores
    End point description
    Mean NEI VFQ-25 score improved from 82.4 at baseline to 92.5 at month 6 (p<0.01) and 94.8 at month 12 (p<0.01).
    End point type
    Secondary
    End point timeframe
    6 and 12 month compared to baseline
    End point values
    		 intravitreal ranibizumab injections Baseline End data- patients after complete follow-up
    Number of subjects analysed
    19 [5]
    20 [6]
    19 [7]
    Units: score
    19
    20
    19
    Notes
    [5] - patients with complete Follow-up
    [6] - 20
    [7] - 19
    No statistical analyses for this end point

    Secondary: Mean Change from baseline in best corrected visual acuity (BCVA) at months 6

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    End point title
    		 Mean Change from baseline in best corrected visual acuity (BCVA) at months 6
    End point description
    Mean change from baseline in BCVA was +20 letters at month 6 (p<0.01)
    End point type
    Secondary
    End point timeframe
    6 months after baseline
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: letters
    20
    19
    No statistical analyses for this end point

    Secondary: Mean Change from baseline in best corrected visual acuity (BCVA) at months 12

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    End point title
    		 Mean Change from baseline in best corrected visual acuity (BCVA) at months 12
    End point description
    Mean change from baseline in BCVA was +23 at month 12 (p<0.01).
    End point type
    Secondary
    End point timeframe
    12 monhs after baseline
    End point values
    		 Baseline End data- patients after complete follow-up
    Number of subjects analysed
    Units: letters
    20
    19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Informed Consent to 12 months after first Administration of study treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20,0
    Reporting groups
    Reporting group title
    Patients who signed Informed Consent
    Reporting group description
    		 -

    Serious adverse events
    		 Patients who signed Informed Consent
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Patients who signed Informed Consent
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 20 (40.00%)
    General disorders and administration site conditions
    Vertigo
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    hematoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Eye disorders
    Intraocular pressure increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    floaters in eye
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Corneal erosion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Meibomian gland dysfunction
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Infections and infestations
    Fever blister
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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