Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase IV, prospective, open-label, uncontrolled, European Study in patients with neovascular Age-related macular degeneration (nAMD), evaluating the efficacy and safety of switching from intravitreal Aflibercept to RanIbizumab 0.5 mg.

    Summary
    EudraCT number
    		 2014-001085-10
    Trial protocol
    		 DE  
    Global end of trial date
    14 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2018
    First version publication date
    30 Sep 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CRFB002AGB17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02161575
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate whether treatment with IVT ranibizumab 0.5 mg was associated with improvement (i.e. reduction at Day 90 from baseline) in central subfield retinal thickness (CSRT), as determined by OCT after 3 monthly injections of ranibizumab.
    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
    28 Aug 2014
    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
    United Kingdom: 87
    Country: Number of subjects enrolled
    Germany: 16
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    6
    From 65 to 84 years
    84
    85 years and over
    13

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited from 22 sites located in the United Kingdom and 6 sites located in Germany. A total of 103 patients received at least 1 dose of study drug.

    Pre-assignment
    Screening details
    		 Of the 103 patients who received at least 1 dose of study drug, 3 patients did not have any post-baseline safety or CSRT assessments and were therefore excluded from the SAF and FAS, in accordance with the analysis set definitions. Therefore, 100 patients were included in the SAF and FAS.

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

    Arms
    Arm title
    		 Ranibizumab
    Arm description
    		 All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    RFB002
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraocular use
    Dosage and administration details
    Intraveal injections of 0.5mg ranibizumab

    Number of subjects in period 1 [1]
    		Ranibizumab
    Started
    100
    Full Analysis Set (FAS) Population
    100
    Safety (SAF) Population
    100
    Completed
    92
    Not completed
    8
         Adverse event, non-fatal
    2
         Protocol deviation
    5
         Lack of efficacy
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 103 patients who received at least 1 dose of study drug, 3 patients did not have any post-baseline safety or CSRT assessments and were therefore excluded from the SAF and FAS.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.

    Reporting group values
    		 Ranibizumab Total
    Number of subjects
    		 100 100
    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)
    		 6 6
        From 65-84 years
    		 81 81
        85 years and over
    		 13 13
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 77 ( 6.51 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 55 55
        Male
    		 45 45
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian|
    		 99 99
        Asian|
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.

    Primary: Change in Central Subfield Retinal Thickness (CSRT) from Baseline to Day 90.

    		 Close Top of page
    End point title
    		 Change in Central Subfield Retinal Thickness (CSRT) from Baseline to Day 90. [1]
    End point description
    Measurement of the change in CSRT, determined by high definition optical coherence tomography (HD-OCT) after 3 monthly injections of ranibizumab. OCT is a non-invasive technique which can determine and measure thickness of the retina. A negative change from Baseline indicates an improvement (less retinal fluid and lower disease activity). Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Primary
    End point timeframe
    Baseline and Day 90
    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: No statistical analyses provided as it was a single arm trial.
    End point values
    		 Ranibizumab
    Number of subjects analysed
    97
    Units: micrometer
    median (full range (min-max))
        Baseline|
    384.00 (154.0 to 975.0)
        Day 90|
    318.00 (170.0 to 832.0)
        Change from Baseline to Day 90|
    -30.75 (-386.0 to 78.0)
    No statistical analyses for this end point

    Secondary: Change in Subfoveal Retinal Thickness (SRT) from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in Subfoveal Retinal Thickness (SRT) from Baseline to Day 180
    End point description
    Measurement of change in SRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: micrometer
    median (full range (min-max))
        SRT at Baseline|
    346.00 (69.0 to 944.5)
        SRT at Day 180|
    302.00 (41.5 to 876.5)
        SRT change from Baseline to Day 180|
    -23.50 (-464.0 to 306.5)
    No statistical analyses for this end point

    Secondary: Change in Central Subfield Retinal Thickness (CSRT) from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in Central Subfield Retinal Thickness (CSRT) from Baseline to Day 180
    End point description
    Measurement of change in CSRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: micrometer
    median (full range (min-max))
        CSRT at Baseline|
    384.00 (154.0 to 975.0)
        CSRT at Day 180|
    343.00 (194.0 to 842.0)
        CSRT change from Baseline to Day 180|
    -28.00 (-271.0 to 171.0)
    No statistical analyses for this end point

    Secondary: Change in Central Subfield Retinal Volume (CSRV) from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in Central Subfield Retinal Volume (CSRV) from Baseline to Day 180
    End point description
    Measurement of change in CSRV from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: cubic micrometer
    median (full range (min-max))
        CSRV at Baseline|
    0.3050 (0.120 to 11.600)
        CSRV at Day 180|
    0.2750 (0.115 to 11.400)
        CSRV change from Baseline to Day 180|
    -0.0200 (-1.600 to 0.135)
    No statistical analyses for this end point

    Secondary: Number of patients with Intraretinal Fluid assessed at Baseline and Day 180

    		 Close Top of page
    End point title
    		 Number of patients with Intraretinal Fluid assessed at Baseline and Day 180
    End point description
    Presence or absence of qualitative OCT parameter Intraretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        Baseline|Yes, Definitive
    32
        Day 180|Yes, Definitive
    24
        Baseline|Yes, Subtle
    11
        Day 180|Yes, Subtle
    15
        Baseline|No
    56
        Day 180|No
    55
        Baseline|Questionable
    1
        Day 180|Questionable
    0
    No statistical analyses for this end point

    Secondary: Number of patients with Subretinal Fluid assessed at Baseline and Day 180

    		 Close Top of page
    End point title
    		 Number of patients with Subretinal Fluid assessed at Baseline and Day 180
    End point description
    Presence or absence of qualitative OCT parameter Subretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        Baseline|Yes, Definitive
    83
        Day 180|Yes, Definitive
    49
        Baseline|Yes, Subtle
    5
        Day 180|Yes, Subtle
    15
        Baseline|No
    12
        Day 180|No
    30
    No statistical analyses for this end point

    Secondary: Number of patients with Intraretinal/Subretinal Fluid Within the Central Subfield Fluid assessed at baseline and Day 180

    		 Close Top of page
    End point title
    		 Number of patients with Intraretinal/Subretinal Fluid Within the Central Subfield Fluid assessed at baseline and Day 180
    End point description
    Presence or absence of qualitative OCT parameter Intraretinal/Subretinal Fluid Within the Central Subfield. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        Baseline|Yes, Definitive
    38
        Day 180|Yes, Definitive
    26
        Baseline|Yes, Subtle
    6
        Day 180|Yes, Subtle
    12
        Baseline|No
    5
        Day 180|No
    15
        Baseline|Questionable
    1
        Day 180|Questionable
    1
        Baseline|NA
    50
        Day 180|NA
    40
    No statistical analyses for this end point

    Secondary: Number of patients with Pigment Epithelial Detachments assessed at baseline and Day 180

    		 Close Top of page
    End point title
    		 Number of patients with Pigment Epithelial Detachments assessed at baseline and Day 180
    End point description
    Presence or absence of qualitative OCT parameter Pigment Epithelial Detachments. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        Baseline|Yes, Definitive
    86
        Day 180|Yes, Definitive
    80
        Baseline|Yes, Subtle
    2
        Day 180|Yes, Subtle
    4
        Baseline|No
    12
        Day 180|No
    8
        Baseline|Not gradable
    0
        Day 180|Not gradable
    2
    No statistical analyses for this end point

    Secondary: Number of patients with Dry Retina assessed at baseline and Day 180

    		 Close Top of page
    End point title
    		 Number of patients with Dry Retina assessed at baseline and Day 180
    End point description
    Presence or absence of qualitative OCT parameter Dry Retina. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        Baseline|Yes, Definitive
    0
        Day 180|Yes, Definitive
    0
        Baseline|No
    100
        Day 180|No
    94
    No statistical analyses for this end point

    Secondary: Change in Maximum PED Height from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in Maximum PED Height from Baseline to Day 180
    End point description
    Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Height. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: micrometer
    median (full range (min-max))
        Baseline|
    236.00 (66.5 to 674.0)
        Day 180|
    203.50 (63.5 to 705.0)
        Change from Baseline to Day 180|
    -2.50 (-336.5 to 131.0)
    No statistical analyses for this end point

    Secondary: Change in Maximum PED Diameter from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in Maximum PED Diameter from Baseline to Day 180
    End point description
    Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Diameter. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: micrometer
    median (full range (min-max))
        Baseline|
    2205.00 (0.0 to 4877.0)
        Day 180|
    2428.00 (471.0 to 4683.0)
        Change from Baseline to Day 180|
    59.50 (-1007.0 to 2756.0)
    No statistical analyses for this end point

    Secondary: Change in Maximum IRC Height from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in Maximum IRC Height from Baseline to Day 180
    End point description
    Change from Baseline to Day 180 in Maximum Intraretinal Cyst (IRC) Height. Data collected on the study eye were used for the evaluation of efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: micrometer
    median (full range (min-max))
        Baseline|
    121.50 (21.0 to 280.5)
        Day 180|
    105.50 (25.5 to 485.0)
        Change from Baseline to Day 180|
    0.00 (-223.5 to 235.0)
    No statistical analyses for this end point

    Secondary: Change in Best Corrected Visual Acuity (BCVA) in the Study Eye

    		 Close Top of page
    End point title
    		 Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
    End point description
    Change in overall BCVA score from Baseline to Day 180, and from Day 90 to Day 180 in the Study Eye.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 90 and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: letters
    median (full range (min-max))
        Baseline|
    71.5 (36 to 90)
        Day 90|
    74.0 (32 to 87)
        Day 180|
    75.0 (32 to 90)
        Change from Baseline to Day 180|
    1.0 (-31 to 35)
        Change from Day 90 to Day 180|
    0.0 (-25 to 24)
    No statistical analyses for this end point

    Secondary: Change in ETDRS Letters for Study Eye from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Change in ETDRS Letters for Study Eye from Baseline to Day 180
    End point description
    Number of patients gaining at least 15 letters from Baseline to Day 180
    End point type
    Secondary
    End point timeframe
    Baseline and Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        >=15 (Gain of at least 15 letters)
    11
        10 to <15
    6
        5 to <10
    17
        0 to <5
    25
        >-15 to <0
    31
        <=-15 (Loss of at least 15 letters)
    7
        NA
    3
    No statistical analyses for this end point

    Secondary: Incidence of ocular TEAEs in the Study Eye reported by ≥2% patients from Baseline to Day 180

    		 Close Top of page
    End point title
    		 Incidence of ocular TEAEs in the Study Eye reported by ≥2% patients from Baseline to Day 180
    End point description
    Incidence of ocular Treatment Emergent Adverse Events (TEAEs) in the study eye reported by ≥2% patients by preferred term.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 180
    End point values
    		 Ranibizumab
    Number of subjects analysed
    100
    Units: Participants
        Eye pain|
    3
        Visual impairment|
    3
        Blepharitis|
    2
        Posterior capsule opacification|
    2
        Intraocular pressure increased|
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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 are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Overall Ranibizumab
    Reporting group description
    		 Overall Ranibizumab

    Serious adverse events
    		 Overall Ranibizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 100 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    CATHETERISATION CARDIAC
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PROSTATIC SPECIFIC ANTIGEN INCREASED
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FALL
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    POST PROCEDURAL HAEMATOMA
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    UMBILICAL HERNIA REPAIR
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VAGINAL PROLAPSE REPAIR
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    RETINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UPPER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VOMITING
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    PROSTATOMEGALY
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    URINARY RETENTION
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.9%
    Non-serious adverse events
    		 Overall Ranibizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 100 (52.00%)
    Investigations
    BLOOD PRESSURE SYSTOLIC INCREASED
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    4 / 100 (4.00%)
         occurrences all number
    5
    HEART RATE DECREASED
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    WEIGHT DECREASED
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    INTRAOCULAR PRESSURE INCREASED
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    4
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    3
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    HEADACHE
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Eye disorders
    BLEPHARITIS
         subjects affected / exposed
    6 / 100 (6.00%)
         occurrences all number
    6
    DRY EYE
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    3
    EYE PAIN
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    3
    POSTERIOR CAPSULE OPACIFICATION
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    VISUAL IMPAIRMENT
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    7 / 100 (7.00%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    3
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Infections and infestations
    CYSTITIS
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    7 / 100 (7.00%)
         occurrences all number
    7
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 100 (9.00%)
         occurrences all number
    9
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2015
    The permitted time period for a historical OCT volume scan was changed from ≤14 days to ≤28 days before the date of first injection of aflibercept to the study eye. The definition of pathologic myopia in Exclusion Criterion 15 was changed from ≥ 8 dioptres to ≥ 6 dioptres.
    11 May 2016
    The sample size calculation was amended, and the study population was changed from 162 to 124 patients.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 16:14:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA