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    Clinical Trial Results:
    A 6-month multicenter, randomized, double-masked phase IIIb-study comparing the efficacy and safety of Lucentis (ranibizumab) intravitreal injections versus Ozurdex (dexamethasone) intravitreal implant in patients with visual impairment due to macular edema following central retinal vein occlusion (CRVO) 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
    		 2011-001020-38
    Trial protocol
    		 DE   GB   HU   CZ   PL  
    Global end of trial date
    21 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CRFB002EDE18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01396083
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Cinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    Scientific contact
    Cinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    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
    21 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to show that ranibizumab (administered in an individualized treatment regimen) has superior efficacy and safety compared to dexamethasone implant (Ozurdex®) over a 6 month period.
    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. In addition, only one eye was chosen as the study eye. If both eyes were eligible, the eye with the worse VA as assessed at the baseline visit was selected for study treatment, unless, based on medical reasons, the investigator deemed the other eye to be more appropriate for study treatment. Only the study eye was treated with either of the study drugs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    United Kingdom: 53
    Country: Number of subjects enrolled
    Germany: 176
    Country: Number of subjects enrolled
    Hungary: 5
    Worldwide total number of subjects
    243
    EEA total number of subjects
    243
    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)
    104
    From 65 to 84 years
    124
    85 years and over
    15

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Three-hundred-twenty-five patients were screened for study eligibility at 66 German and European study sites while 82 patients failed screening (multiple reasons per patient were possible). In total, 243 patients were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ranibizumab
    Arm description
    		 Randomized patients received injections of 0.5 mg ranibizumab according to the proposed European label: consecutive monthly intravitreal injections with 0.5 mg ranibizumab until visual acuity (VA) stability was achieved, followed by a PRN (pro re nata/taken as needed) re-treatment if there was a decline from stable VA levels due to macular edema. Stability could be confirmed when a patient’s VA was stable for three consecutive monthly assessments performed while on ranibizumab treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    RFB002
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/0.05 ml solution to be injected intravitreally

    Arm title
    		 Dexamethasone
    Arm description
    		 Patients randomized to dexamethasone received a single intravitreal implant (700 µg; long acting release [LAR] over 6 months) at baseline and sham-injections thereafter.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients randomized to dexamethasone received a single intravitreal implant (700 µg; long acting release (LAR) over 6 months) at baseline and sham-injections thereafter.

    Number of subjects in period 1
    		Ranibizumab Dexamethasone
    Started
    124
    119
    Completed
    113
    72
    Not completed
    11
    47
         Abnormal laboratory value(s)
    1
    -
         Consent withdrawn by subject
    4
    5
         Unsatisfactory therapeutic effect
    2
    13
         Administrative problems
    1
    -
         Adverse Event(s)
    2
    28
         Lost to follow-up
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 Randomized patients received injections of 0.5 mg ranibizumab according to the proposed European label: consecutive monthly intravitreal injections with 0.5 mg ranibizumab until visual acuity (VA) stability was achieved, followed by a PRN (pro re nata/taken as needed) re-treatment if there was a decline from stable VA levels due to macular edema. Stability could be confirmed when a patient’s VA was stable for three consecutive monthly assessments performed while on ranibizumab treatment.

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Patients randomized to dexamethasone received a single intravitreal implant (700 µg; long acting release [LAR] over 6 months) at baseline and sham-injections thereafter.

    Reporting group values
    		 Ranibizumab Dexamethasone Total
    Number of subjects
    		 124 119 243
    Age categorical
    Units: Subjects
        ≤65 years
    		 59 52 111
        >65 years
    		 65 67 132
    Age continuous
    The EMA result system autopopulates the “-“ and will not allow the entry of the mean age for the trial, which is 66.1 (standard deviation 11.9)
    Units: years
        arithmetic mean (standard deviation)
    		 65.3 ± 11.4 66.9 ± 12.4 -
    Gender categorical
    Units: Subjects
        Female
    		 52 46 98
        Male
    		 72 73 145

    End points

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    End points reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 Randomized patients received injections of 0.5 mg ranibizumab according to the proposed European label: consecutive monthly intravitreal injections with 0.5 mg ranibizumab until visual acuity (VA) stability was achieved, followed by a PRN (pro re nata/taken as needed) re-treatment if there was a decline from stable VA levels due to macular edema. Stability could be confirmed when a patient’s VA was stable for three consecutive monthly assessments performed while on ranibizumab treatment.

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Patients randomized to dexamethasone received a single intravitreal implant (700 µg; long acting release [LAR] over 6 months) at baseline and sham-injections thereafter.

    Primary: Mean Average best corrected visual acuity (BCVA) Change From Month 1 Through Month 6 to Baseline

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    End point title
    		 Mean Average best corrected visual acuity (BCVA) Change From Month 1 Through Month 6 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.
    End point type
    Primary
    End point timeframe
    The average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at Month 1 to 6.
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124 [1]
    119 [2]
    Units: letters
        least squares mean (confidence interval 95%)
    12.86 (10.24 to 15.48)
    2.96 (0.27 to 5.64)
    Notes
    [1] - Full analysis set , Last observation carried forward (LOCF)
    [2] - Full analysis set, Last observation carried forward (LOCF)
    Statistical analysis title
    		 Full Analysis Set
    Statistical analysis description
    The Full Analysis Set consisted of all patients from the Randomized Set who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. The null-hypothesis to be rejected was that there is no difference in the change of BCVA (letters), averaged over all post-baseline visits, between patients under ranibizumab and those under dexamethasone.
    Comparison groups
    Ranibizumab v Dexamethasone
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    9.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.51
         upper limit
    		 13.3
    Notes
    [3] - The primary analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment, and covariate baseline BCVA as predictors.

    Secondary: Mean BCVA Change at Month 6

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    End point title
    		 Mean BCVA Change at Month 6
    End point description
    To compare the mean BCVA change at Month 6 from Baseline in patients treated with dexamethasone versus ranibizumab.The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment, and covariate baseline BCVA as predictors.
    End point type
    Secondary
    End point timeframe
    Baseline, month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124
    119
    Units: letters
        least squares mean (confidence interval 95%)
    14.78 (11.24 to 18.32)
    -3.17 (-6.8 to 0.46)
    No statistical analyses for this end point

    Secondary: Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters

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    End point title
    		 Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
    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 number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline. This analysis is done on the full analysis set (FAS) which consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124 [4]
    119 [5]
    Units: patients
        Gain≥15 letters
    73
    22
        Loss of ≥15 letters
    1
    31
        Gain ≥10 letters
    89
    38
        Loss of ≥10 letters
    4
    35
        Gain ≥5 letters
    104
    54
        Loss of ≥5 letters
    5
    40
    Notes
    [4] - Full Analysis Set
    [5] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Time to Achieve a Significant Improvement ≥ 15 Letters

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    End point title
    		 Time to Achieve a Significant Improvement ≥ 15 Letters
    End point description
    The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts. This was based on the full analysis set (FAS), which consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. For the dexamethasone treatment group, 99999.9 represents not applicable data becasue EudraCT system is not accepting "NA" for not available/not applicable data.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124
    119
    Units: Days
        median (confidence interval 95%)
    62 (56 to 91)
    98 (63 to 99999.9)
    No statistical analyses for this end point

    Secondary: Change Over Time in BCVA (letters)

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    End point title
    		 Change Over Time in BCVA (letters)
    End point description
    The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors, for the Full Analysis Set (FAS) and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124
    119
    Units: letters
    least squares mean (confidence interval 95%)
        Month 1
    9.77 (7.27 to 12.27)
    9.54 (6.98 to 12.1)
        Month 2
    12.25 (9.59 to 14.91)
    11.04 (8.31 to 13.76)
        Month 3
    14.04 (10.92 to 17.16)
    4.99 (1.79 to 8.18)
        Month 4
    12.76 (9.48 to 16.04)
    -1.73 (-5.09 to 1.63)
        Month 5
    13.57 (10.25 to 16.89)
    -2.92 (-6.33 to 0.48)
        Month 6
    14.78 (11.24 to 18.32)
    -3.17 (-6.8 to 0.46)
    No statistical analyses for this end point

    Secondary: Change Over Time of the Central Retinal Thickness (CRT)

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    End point title
    		 Change Over Time of the Central Retinal Thickness (CRT)
    End point description
    Retinal thickness was measured using Optical Coherence Tomography (OCT). Data presented are the course of CRT (µm) over time from baseline to month 6, assessed by investigator (Full Analysis Set/Last Observation Carried Forward).
    End point type
    Secondary
    End point timeframe
    Baseline, month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124
    119
    Units: µm
    arithmetic mean (standard deviation)
        Change Over Time of the Central Retinal Thickness
    -376.7 ± 274.9
    -168.7 ± 288.3
    No statistical analyses for this end point

    Secondary: Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires

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    End point title
    		 Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
    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. An overall composite score can be calculated and is provided.
    End point type
    Secondary
    End point timeframe
    Composite score Baseline, 6 months
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    121
    118
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Changes in the NEI-VFQ 25 Questionnaire
    6 ± 12.1
    2 ± 10.9
    No statistical analyses for this end point

    Secondary: Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36) Questionnaires

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    End point title
    		 Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36) Questionnaires
    End point description
    SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health.
    End point type
    Secondary
    End point timeframe
    Baseline, month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    116
    113
    Units: Units on a scale
    arithmetic mean (standard deviation)
        SF-36 physical component (n=116,113)
    -0.7 ± 6.3
    0.4 ± 6.6
        SF-36 mental component (n=116,113)
    2.4 ± 8.7
    0.4 ± 9.2
    No statistical analyses for this end point

    Secondary: Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires

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    End point title
    		 Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
    End point description
    The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
    End point type
    Secondary
    End point timeframe
    Baseline, month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    119
    114
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Changes in QOL according to EQ-5D
    0.1 ± 13.2
    2 ± 14.8
    No statistical analyses for this end point

    Secondary: Increase Rate of Intraocular Pressure (IOP): number of patients with ≥10% increase in IOP compared to baseline (safety set)

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    End point title
    		 Increase Rate of Intraocular Pressure (IOP): number of patients with ≥10% increase in IOP compared to baseline (safety set)
    End point description
    The number of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.
    End point type
    Secondary
    End point timeframe
    Baseline, month 6
    End point values
    		 Ranibizumab Dexamethasone
    Number of subjects analysed
    124
    119
    Units: Patients
        Any post-baseline visit
    94
    105
    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
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 Randomized patients received injections of 0.5 mg ranibizumab according to the proposed European label: consecutive monthly intravitreal injections with 0.5 mg ranibizumab until visual acuity (VA) stability was achieved, followed by a PRN (pro re nata/taken as needed) re-treatment if there was a decline from stable VA levels due to macular edema. Stability could be confirmed when a patient’s VA was stable for three consecutive monthly assessments performed while on ranibizumab treatment.

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Patients randomized to dexamethasone received a single intravitreal implant (700 μg; long acting release [LAR] over 6 months) at baseline and sham-injections thereafter.

    Serious adverse events
    		 Ranibizumab Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 124 (8.06%)
    16 / 119 (13.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL CARCINOMA
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL NEOPLASM
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         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
    ASTHENIA
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    PROSTATITIS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    INTRAOCULAR PRESSURE DECREASED (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTRAOCULAR PRESSURE INCREASED (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROSTATIC SPECIFIC ANTIGEN INCREASED
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    UPPER LIMB FRACTURE
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WRIST FRACTURE
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    ADENOMATOUS POLYPOSIS COLI
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ANGINA PECTORIS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MITRAL VALVE INCOMPETENCE
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RADIAL NERVE PALSY
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 119 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    DEAFNESS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    CONJUNCTIVAL HYPERAEMIA (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORNEAL OEDEMA (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EYE PAIN (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GLAUCOMA (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    3 / 119 (2.52%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPHAEMA (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    3 / 119 (2.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IRIS NEOVASCULARISATION (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    4 / 119 (3.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MACULAR OEDEMA (Study eye)
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 119 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL ARTERY OCCLUSION (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL VEIN OCCLUSION (Study eye)
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VISUAL ACUITY REDUCED (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    3 / 119 (2.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VITREOUS HAEMORRHAGE (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL HERNIA
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRODUODENAL ULCER
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL RUPTURE
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UMBILICAL HERNIA
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    CYSTITIS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOFT TISSUE INFECTION
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.5%
    Non-serious adverse events
    		 Ranibizumab Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 124 (62.10%)
    99 / 119 (83.19%)
    Investigations
    BLOOD GLUCOSE INCREASED
         subjects affected / exposed
    4 / 124 (3.23%)
    2 / 119 (1.68%)
         occurrences all number
    4
    2
    INTRAOCULAR PRESSURE INCREASED (Fellow eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    3 / 119 (2.52%)
         occurrences all number
    0
    3
    INTRAOCULAR PRESSURE INCREASED (Study eye)
         subjects affected / exposed
    7 / 124 (5.65%)
    38 / 119 (31.93%)
         occurrences all number
    10
    41
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    5 / 124 (4.03%)
    3 / 119 (2.52%)
         occurrences all number
    6
    3
    VASCULAR SHUNT (Study eye)
         subjects affected / exposed
    1 / 124 (0.81%)
    3 / 119 (2.52%)
         occurrences all number
    1
    3
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    7 / 124 (5.65%)
    10 / 119 (8.40%)
         occurrences all number
    9
    11
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    0 / 124 (0.00%)
    3 / 119 (2.52%)
         occurrences all number
    0
    3
    Eye disorders
    ABNORMAL SENSATION IN EYE (Study eye)
         subjects affected / exposed
    6 / 124 (4.84%)
    8 / 119 (6.72%)
         occurrences all number
    8
    9
    CONJUNCTIVAL HAEMORRHAGE (Study eye)
         subjects affected / exposed
    16 / 124 (12.90%)
    13 / 119 (10.92%)
         occurrences all number
    18
    13
    DRY EYE (Fellow eye)
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 119 (0.84%)
         occurrences all number
    4
    1
    DRY EYE (Study eye)
         subjects affected / exposed
    4 / 124 (3.23%)
    4 / 119 (3.36%)
         occurrences all number
    4
    5
    EYE IRRITATION (Study eye)
         subjects affected / exposed
    4 / 124 (3.23%)
    3 / 119 (2.52%)
         occurrences all number
    5
    5
    EYE PAIN (Study eye)
         subjects affected / exposed
    15 / 124 (12.10%)
    14 / 119 (11.76%)
         occurrences all number
    22
    16
    FOREIGN BODY SENSATION IN EYES (Study eye)
         subjects affected / exposed
    6 / 124 (4.84%)
    6 / 119 (5.04%)
         occurrences all number
    6
    6
    GLAUCOMA (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    5 / 119 (4.20%)
         occurrences all number
    0
    5
    IRIS NEOVASCULARISATION (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    5 / 119 (4.20%)
         occurrences all number
    0
    5
    LACRIMATION INCREASED (Study eye)
         subjects affected / exposed
    6 / 124 (4.84%)
    8 / 119 (6.72%)
         occurrences all number
    7
    8
    MACULAR ISCHAEMIA (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    3 / 119 (2.52%)
         occurrences all number
    0
    3
    MACULAR OEDEMA (Study eye)
         subjects affected / exposed
    13 / 124 (10.48%)
    19 / 119 (15.97%)
         occurrences all number
    14
    21
    OCULAR HYPERAEMIA (Study eye)
         subjects affected / exposed
    14 / 124 (11.29%)
    15 / 119 (12.61%)
         occurrences all number
    27
    20
    OCULAR HYPERTENSION (Study eye)
         subjects affected / exposed
    0 / 124 (0.00%)
    6 / 119 (5.04%)
         occurrences all number
    0
    10
    OPTIC DISC VASCULAR DISORDER (Study eye)
         subjects affected / exposed
    5 / 124 (4.03%)
    0 / 119 (0.00%)
         occurrences all number
    5
    0
    RETINAL EXUDATES (Study eye)
         subjects affected / exposed
    2 / 124 (1.61%)
    4 / 119 (3.36%)
         occurrences all number
    2
    4
    RETINAL ISCHAEMIA (Study eye)
         subjects affected / exposed
    1 / 124 (0.81%)
    6 / 119 (5.04%)
         occurrences all number
    1
    6
    RETINAL VASCULAR DISORDER (Study eye)
         subjects affected / exposed
    2 / 124 (1.61%)
    5 / 119 (4.20%)
         occurrences all number
    2
    5
    VISUAL ACUITY REDUCED (Study eye)
         subjects affected / exposed
    8 / 124 (6.45%)
    19 / 119 (15.97%)
         occurrences all number
    10
    19
    VISUAL IMPAIRMENT (Study eye)
         subjects affected / exposed
    2 / 124 (1.61%)
    6 / 119 (5.04%)
         occurrences all number
    2
    6
    VITREOUS DETACHMENT (Study eye)
         subjects affected / exposed
    5 / 124 (4.03%)
    3 / 119 (2.52%)
         occurrences all number
    5
    3
    VITREOUS FLOATERS (Study eye)
         subjects affected / exposed
    5 / 124 (4.03%)
    11 / 119 (9.24%)
         occurrences all number
    6
    11
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    6 / 124 (4.84%)
    2 / 119 (1.68%)
         occurrences all number
    7
    2
    NAUSEA
         subjects affected / exposed
    4 / 124 (3.23%)
    3 / 119 (2.52%)
         occurrences all number
    4
    4
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    2 / 124 (1.61%)
    3 / 119 (2.52%)
         occurrences all number
    3
    3
    BACK PAIN
         subjects affected / exposed
    7 / 124 (5.65%)
    4 / 119 (3.36%)
         occurrences all number
    7
    4
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    1 / 124 (0.81%)
    3 / 119 (2.52%)
         occurrences all number
    1
    3
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 124 (7.26%)
    12 / 119 (10.08%)
         occurrences all number
    9
    16
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 124 (0.81%)
    4 / 119 (3.36%)
         occurrences all number
    1
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2011
    This amendment was introduced to include: • Addition of country-specific requirements regarding the use of contraception and pregnancy advice within the United Kingdom • Addition of the use of antimicrobial drops for 3 days before any visit when an injection was scheduled to be performed as required by local or country-specific practices, • Addition of minor changes including some typographical errors
    10 Oct 2011
    As Lucentis (ranibizumab) became commercially available in May 2011 for the treatment of RVO, the protocol amendment was made to allow for usage of both commercially available Lucentis (according to local requirements and approvals) as well as ranibizumab clinical trial stock. Furthermore, changes were made concerning the study drug preparation procedure in that for sham injections empty vials were no longer provided. In order to maintain the masking only the syringe, either empty in the case of sham-injections or pre-filled in the case of ranibizumab injections, were visible to the patient in the room of study drug administration; study drug withdrawal took place in a separate room or area, such that the patient remained masked to treatment. This procedure was in line with usual medical practice. Finally, administrative errors have been corrected. The following sections of the protocol had been changed: Investigational and control drugs, Dispensing the study drug, Assessment schedule, Treatment procedures
    12 Dec 2011
    Amendment was made to consolidate the changes made in the two previous amendments in a single amended protocol. Additionally, minor changes and corrections were made: Efficacy, Assessment schedule.

    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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