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    Clinical Trial Results:
    Intravitreal Ranibizumab (Lucentis) Therapy in Patients with Diabetic Ischaemic Macular Oedema (DIME)

    Summary
    EudraCT number
    		 2013-000031-27
    Trial protocol
    		 GB  
    Global end of trial date
    04 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Mar 2019
    First version publication date
    14 Mar 2019
    Other versions
    Summary report(s)
    		 Premature end of study - no results

    Trial information

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    Trial identification
    Sponsor protocol code
    MICM1008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Moorfields Eye Hospital NHS Foundation Trust
    Sponsor organisation address
    162 City Road, London, United Kingdom, EC1V 2PD
    Public contact
    Natasha Ajraam Research Facilitator, Moorfields Eye Hospital NHS Foundation Trust, 020 72533411, natasha.ajraam@moorfields.nhs.uk
    Scientific contact
    Natasha Ajraam Research Facilitator, Moorfields Eye Hospital NHS Foundation Trust, 020 72533411, natasha.ajraam@moorfields.nhs.uk
    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
    04 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Is the use of Lucentis therapy in patients with Diabetic Ischaemic Macular Oedema (DIME) safe?
    Protection of trial subjects
    No patients were recruited in this study. 1 patient entered to allow completion of the record, however no patients were recruited.
    Background therapy
    		 0
    Evidence for comparator
    		 0
    Actual start date of recruitment
    01 Feb 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
    United Kingdom: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No recruitment, study abandoned.

    Pre-assignment
    Screening details
    		 No screening, study abandoned.

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

    Arms
    Arm title
    		 Injection
    Arm description
    		 phase III/IV non-randomised, prospective case series
    Arm type
    		 injection

    Investigational medicinal product name
    Lucentis therapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Ocular use
    Dosage and administration details
    Lucentis injections (0.5mg) will be administered monthly for 3 months then according to clinical need for a total of 12 months of follow-up. A minimum of 5 intravitreal Lucentis injections will be administered prior to a decision being taken that there is a lack of clinical response.

    Number of subjects in period 1
    		Injection
    Started
    1
    Completed
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Injection
    Reporting group description
    		 phase III/IV non-randomised, prospective case series

    Subject analysis set title
    Safety data
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    1. Macular perfusion (FAZ greatest linear dimension (GLD) and degree of perifoveal capillary loss)

    Primary: Macular perfusion (FAZ greatest linear dimension (GLD) and degree of perifoveal capillary loss)

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    End point title
    		 Macular perfusion (FAZ greatest linear dimension (GLD) and degree of perifoveal capillary loss) [1]
    End point description
    End point type
    Primary
    End point timeframe
    30 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no patients were recruited as the study was abandoned.
    End point values
    		 Injection
    Number of subjects analysed
    1 [2]
    Units: FAZ greatest linear dimension (GLD)
        number (not applicable)
    1
    Notes
    [2] - no patients recruited
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    as per protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: no patients were recruited as the study was abandoned.

    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
    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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