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    Clinical Trial Results:
    A Phase 2, single-masked, multicentre study to evaluate the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular oedema (DME)

    Summary
    EudraCT number
    2016-002100-25
    Trial protocol
    HU   CZ   SK  
    Global end of trial date
    11 Apr 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    31 Mar 2019
    First version publication date
    31 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    THR-317-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03071068
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ThromboGenics NV
    Sponsor organisation address
    Gaston Geenslaan 1, Leuven, Belgium, 3001
    Public contact
    Global Clinical Development, ThromboGenics NV, 32 16751310, info@oxurion.com
    Scientific contact
    Global Clinical Development, ThromboGenics NV, 32 16751310, info@oxurion.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
    01 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4mg or 8mg) and to assess its efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with centre-involved DME
    Protection of trial subjects
    All study procedures, including the intravitreal injections, were performed by qualified and trained personnel. Only eligible subjects were enrolled in the study and only subjects who did not meet any withdrawal criteria received repeat injections. All subjects were supervised in the immediate post-injection period with appropriate medical treatment readily available. Subjects were followed up for 3 months after the last intravitreal injection. Adverse events were recorded throughout the study period. At each study visit, a full ophthalmic examination and BCVA assessment was performed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Dec 2016
    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
    Hungary: 11
    Country: Number of subjects enrolled
    Slovakia: 18
    Country: Number of subjects enrolled
    Czech Republic: 20
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    22
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Before enrolment in the study, a Screening Visit took place during which in- and exclusion criteria were checked.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    THR-317 4mg
    Arm description
    3 intravitreal injections of THR-317 4mg approximately 1 month apart
    Arm type
    Experimental

    Investigational medicinal product name
    THR-317 4mg
    Investigational medicinal product code
    THR-317
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    3 intravitreal injections of THR-317 4mg approximately 1 month apart

    Arm title
    THR-317 8mg
    Arm description
    3 intravitreal injections of THR-317 8mg approximately 1 month apart
    Arm type
    Experimental

    Investigational medicinal product name
    THR-317 8mg
    Investigational medicinal product code
    THR-317
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    3 intravitreal injections of THR-317 8mg approximately 1 month apart

    Number of subjects in period 1
    THR-317 4mg THR-317 8mg
    Started
    24
    25
    Completed
    23
    25
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    THR-317 4mg
    Reporting group description
    3 intravitreal injections of THR-317 4mg approximately 1 month apart

    Reporting group title
    THR-317 8mg
    Reporting group description
    3 intravitreal injections of THR-317 8mg approximately 1 month apart

    Reporting group values
    THR-317 4mg THR-317 8mg Total
    Number of subjects
    24 25 49
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.8 ( 8.40 ) 65.8 ( 8.61 ) -
    Gender categorical
    Units: Subjects
        Female
    12 14 26
        Male
    12 11 23

    End points

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    End points reporting groups
    Reporting group title
    THR-317 4mg
    Reporting group description
    3 intravitreal injections of THR-317 4mg approximately 1 month apart

    Reporting group title
    THR-317 8mg
    Reporting group description
    3 intravitreal injections of THR-317 8mg approximately 1 month apart

    Primary: Incidence of acute (up to the 7 day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject

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    End point title
    Incidence of acute (up to the 7 day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject [1]
    End point description
    End point type
    Primary
    End point timeframe
    up to 7-day follow-up visit after each injection
    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: The scope of the primary endpoint was descriptive, no statistical hypothesis test was performed.
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    24
    25
    Units: subjects
        after the first injection
    0
    1
        after the second injection
    3
    1
        after the third injection
    0
    2
        across injections
    3
    4
    No statistical analyses for this end point

    Secondary: Incidence of systemic and ocular (S)AEs up to the 30 day follow-up visit, after each injection and across injections per subject

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    End point title
    Incidence of systemic and ocular (S)AEs up to the 30 day follow-up visit, after each injection and across injections per subject
    End point description
    End point type
    Secondary
    End point timeframe
    up to 30-day follow-up visit after each injection
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    24
    25
    Units: subjects
        after the first injection
    3
    3
        after the second injection
    5
    3
        after the third injection
    3
    4
        across injections
    9
    9
    No statistical analyses for this end point

    Secondary: Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150

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    End point title
    Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
    End point description
    End point type
    Secondary
    End point timeframe
    from first injection, up to Day 90 and up to Day 150
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    24
    25
    Units: subjects
        from first injection up to Day 90
    9
    9
        from first injection up to Day 150
    9
    11
    No statistical analyses for this end point

    Secondary: Number of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit

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    End point title
    Number of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
    End point description
    End point type
    Secondary
    End point timeframe
    at Day 150
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    23
    25
    Units: subjects
        loss of ≥ 15 ETDRS letters in BCVA from Baseline
    0
    1
        loss of ≥ 10 ETDRS letters in BCVA from Baseline
    1
    1
        loss of ≥ 5 ETDRS letters in BCVA from Baseline
    2
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the first injection

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    End point title
    Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the first injection
    End point description
    End point type
    Secondary
    End point timeframe
    after the first injection
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    24
    25
    Units: subjects
        acute loss of ≥ 15 ETDRS letters in BCVA
    0
    0
        acute loss of ≥ 10 ETDRS letters in BCVA
    0
    0
        acute loss of ≥ 5 ETDRS letters in BCVA
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the second injection

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    End point title
    Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the second injection
    End point description
    End point type
    Secondary
    End point timeframe
    after the second injection
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    23
    25
    Units: subjects
        acute loss of ≥ 15 ETDRS letters in BCVA
    0
    0
        acute loss of ≥ 10 ETDRS letters in BCVA
    0
    0
        acute loss of ≥ 5 ETDRS letters in BCVA
    1
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the third injection

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    End point title
    Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the third injection
    End point description
    End point type
    Secondary
    End point timeframe
    after the third injection
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    23
    25
    Units: subjects
        acute loss of ≥ 15 ETDRS letters in BCVA
    0
    0
        acute loss of ≥ 10 ETDRS letters in BCVA
    0
    0
        acute loss of ≥ 5 ETDRS letters in BCVA
    1
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit

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    End point title
    Number of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
    End point description
    End point type
    Secondary
    End point timeframe
    at Day 90
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    23
    25
    Units: subjects
    1
    7
    No statistical analyses for this end point

    Secondary: Mean change from baseline in BCVA, by study visit

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    End point title
    Mean change from baseline in BCVA, by study visit
    End point description
    End point type
    Secondary
    End point timeframe
    at Day 90
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    23
    25
    Units: ETDRS letters
        arithmetic mean (confidence interval 95%)
    3.2 (0.4 to 6.0)
    6.8 (2.9 to 10.8)
    No statistical analyses for this end point

    Secondary: Mean change from baseline in CST, by study visit, based on SD-OCT

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    End point title
    Mean change from baseline in CST, by study visit, based on SD-OCT
    End point description
    End point type
    Secondary
    End point timeframe
    at Day 90
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    23
    25
    Units: µm
        arithmetic mean (confidence interval 95%)
    -19.0 (-56.9 to 18.9)
    -30.3 (-64.3 to 3.8)
    No statistical analyses for this end point

    Secondary: Number of subjects withdrawn from repeat injection

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    End point title
    Number of subjects withdrawn from repeat injection
    End point description
    End point type
    Secondary
    End point timeframe
    prior to the second injection and prior to the third injection
    End point values
    THR-317 4mg THR-317 8mg
    Number of subjects analysed
    24
    25
    Units: subjects
        prior to the second injection
    1
    0
        prior to the third injection
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first injection up to Day 150
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    THR-317 4mg
    Reporting group description
    3 intravitreal injections of THR-317 4mg approximately 1 month apart

    Reporting group title
    THR-317 8mg
    Reporting group description
    3 intravitreal injections of THR-317 8mg approximately 1 month apart

    Serious adverse events
    THR-317 4mg THR-317 8mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    THR-317 4mg THR-317 8mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 24 (16.67%)
    3 / 25 (12.00%)
    Eye disorders
    Visual Impairment
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2

    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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