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    Clinical Trial Results:
    Influence of sustained-release dexamethasone on intraocular cytokines and growth factors and retinal blood vessels in retinal vein occlusion

    Summary
    EudraCT number
    		 2012-000800-13
    Trial protocol
    		 AT  
    Global end of trial date
    01 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2020
    First version publication date
    12 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Währinger Gürtel 18-20, Wien, Austria, 1090
    Public contact
    MUW, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, +43 1404007931, stefan.sacu@meduniwien.ac.at
    Scientific contact
    MUW, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, +43 1404007931, stefan.sacu@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of intravitreal Ozurdex® treatment on the anterior chamber cytokine and growth factor levels and on retinal vessel oxygenation after either CRVO or BRVO
    Protection of trial subjects
    A recent study demonstrated the safety of intravitreal Ozurdex® treatment over a 12 month period. Most of the examination techniques used in this study are non-invasive. The only invasive investigation is anterior chamber paracentesis, but this is usually well tolerated and its safety has been demonstrated in previous studies. The risk/benefit ratio is therefore acceptable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 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
    Austria: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    8
    From 65 to 84 years
    25
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 40 patients were recruited for this study; 25 with BRVO, and 15 with CRVO.

    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
    		 All patients
    Arm description
    		 -
    Arm type
    		 Intervention

    Investigational medicinal product name
    Dexamethasone intravitreal implant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0,7mg

    Number of subjects in period 1
    		All patients
    Started
    40
    Completed
    40

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 40 40
    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)
    		 8 8
        From 65-84 years
    		 25 25
        85 years and over
    		 7 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.5 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Primary: Cytokine levels

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    End point title
    		 Cytokine levels [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 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: Justification: Anova and the paired t-test was performed to investigate the longitudinal changes in cytokine levels, retinal vessel diameters, retrobulbar flow velocities and retinal blood flow. A p-value ≤0.05 is considered as statistical significant. Descriptive analysis will be performed for patient´s demographic data, furthermore, chi²-Test was used for nominal parameters.
    End point values
    		 All patients
    Number of subjects analysed
    40
    Units: pg/ml
        arithmetic mean (standard deviation)
    19.3 ( 8.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events, serious adverse events were collected by spontaneous reporting during the study period. Nonserious adverse events and SUSARs are documented on an "Adverse event" page in the case record form.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Intraocular pressure increase
    Reporting group description
    		 -

    Serious adverse events
    		 Intraocular pressure increase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intraocular pressure increase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 40 (30.00%)
    Eye disorders
    intraocular pressure increase
         subjects affected / exposed
    12 / 40 (30.00%)
         occurrences all number
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

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