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    Clinical Trial Results:
    Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment.

    Summary
    EudraCT number
    		 2013-001208-12
    Trial protocol
    		 NL  
    Global end of trial date
    01 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jul 2021
    First version publication date
    26 Jul 2021
    Other versions
    Summary report(s)
    		 Manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    44122
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Philips van leydenlaan 15, Nijmegem, Netherlands,
    Public contact
    Investigator, Radboud University Nijmegen Medical Centre, f.vanasten@ohk.umcn.nl
    Scientific contact
    Investigator, Radboud University Nijmegen Medical Centre, f.vanasten@ohk.umcn.nl
    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
    01 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to examine features of treatment response on optical coherence tomography in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment.
    Protection of trial subjects
    In accordance to section 10, subsection 1, of the WMO, the investigator will inform the subjects and the reviewing accredited METC if anything occurs, on the basis of which it appears that the disadvantages of participation may be significantly greater than was foreseen in the research proposal. The study will be suspended pending further review by the accredited METC, except insofar as suspension would jeopardise the subjects’ health. The investigator will take care that all subjects are kept informed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2013
    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
    Netherlands: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    2
    From 65 to 84 years
    5
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 patients with neovascular age-related macular degeneration that have shown inadequate response to anti-VEGF treatment, defined as a persistant central retinal thickness on optical coherence tomography (OCT) of ≥300 μm

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

    Arms
    Arm title
    		 aflibercept
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    aflibercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2 mg in 0.05 mL

    Number of subjects in period 1
    		aflibercept
    Started
    9
    Completed
    9
    Period 2
    Period 2 title
    3 months
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 aflibercept
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    aflibercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2 mg in 0.05 mL

    Number of subjects in period 2
    		aflibercept
    Started
    9
    Completed
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 9 9
    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)
    		 2 2
        From 65-84 years
    		 5 5
        85 years and over
    		 2 2
    Age continuous
    75 (55-87)
    Units: years
        median (full range (min-max))
    		 75 (55 to 87) -
    Gender categorical
    male 4 female 5
    Units: Subjects
        Female
    		 5 5
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    aflibercept
    Reporting group description
    		 -
    Reporting group title
    aflibercept
    Reporting group description
    		 -

    Primary: central retinal thickness

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    End point title
    		 central retinal thickness
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    		 aflibercept aflibercept
    Number of subjects analysed
    9
    9
    Units: micrometer(s)
        number (not applicable)
    9
    9
    Statistical analysis title
    		 change in CRT
    Statistical analysis description
    The change in central retinal thickness between inclusion and one month after 3 monthly aflibercept injections will be measured on OCT imaging in μm and will be presented as the mean change in central retinal thickness from baseline (± standard deviation). In case of missing data, the patient cannot be included in the analysis. Whether change in central retinal thickness is significant will be determined by paired T-test.
    Comparison groups
    aflibercept v aflibercept
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Confidence interval
    Notes
    [1] - paired T-test

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAE: 15 days SAE life threatening: 7 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: there were no adverse events reported in this study.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27350361
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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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