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    Clinical Trial Results:
    Early treatment of patients with central serous retinopathy: A randomized controlled trial

    Summary
    EudraCT number
    2009-017959-98
    Trial protocol
    NL  
    Global end of trial date
    04 Jul 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Dec 2020
    First version publication date
    23 Aug 2018
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    publication

    Trial information

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    Trial identification
    Sponsor protocol code
    OZR-2009-26
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Nederlands Trial Register: NTR2261
    Sponsors
    Sponsor organisation name
    Rotterdam Eye Hospital
    Sponsor organisation address
    PO Box 70030, Rotterdam, Netherlands, 3000LM
    Public contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, 31 (0)104023449, roi@oogziekenhuis.nl
    Scientific contact
    Rotterdam Ophthalmic Institut, Rotterdam Ophthalmic Institute The Rotterdam Eye Hospital, 31 (0)104023449, roi@oogziekenhuis.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
    30 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the outcome in CSR patients comparing treatment with PDT versus observation.
    Protection of trial subjects
    No specific measures.
    Background therapy
    There is no agreement concerning the early treatment of central serous retinopathy (CSR). In literature, clinical case series using photodynamic therapy (PDT) show favorable results. In this study patients were randomized between an observational and an early PDT treatment arm. In the observational arm, patients with persistent lesions at 3 months were treated with PDT in agreement with current standard of care.
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    52
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients presenting with CSR with poor prognostic factors.

    Pre-assignment
    Screening details
    No previous history of CSR in either eye. Poor prognostic acute CSR with at least one of the following lesion characteristics: 1) initial localization within 1 disk diameter of the fovea, 2) number of lesions 3 or more, 3) total lesion surface 1 disk area or more.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Control
    Arm description
    No immediate treatment
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Active
    Arm description
    Immediate PDT.
    Arm type
    Experimental

    Investigational medicinal product name
    Photodynamic therapy (Visudyne)
    Investigational medicinal product code
    Visudyne
    Other name
    verteporfine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Body weight corrected dose, single administration

    Number of subjects in period 1
    Control Active
    Started
    26
    26
    Completed
    21
    22
    Not completed
    5
    4
         Lost to follow-up
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    No immediate treatment

    Reporting group title
    Active
    Reporting group description
    Immediate PDT.

    Reporting group values
    Control Active Total
    Number of subjects
    26 26 52
    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)
    44.5 ( 7.6 ) 43.1 ( 7.1 ) -
    Gender categorical
    Units: Subjects
        Female
    9 4 13
        Male
    17 22 39
    Visual acuity
    BCVA on ETDRS
    Units: letters
        arithmetic mean (standard deviation)
    82.0 ( 10.8 ) 84.5 ( 5.0 ) -
    Central foveal thickness
    Units: micrometers
        arithmetic mean (standard deviation)
    400 ( 124 ) 428 ( 117 ) -

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    No immediate treatment

    Reporting group title
    Active
    Reporting group description
    Immediate PDT.

    Primary: Visual acuity at 12 months

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    End point title
    Visual acuity at 12 months
    End point description
    End point type
    Primary
    End point timeframe
    Visual acuity at 12 months
    End point values
    Control Active
    Number of subjects analysed
    22
    21
    Units: letters
        arithmetic mean (standard deviation)
    89.2 ( 7.5 )
    90.5 ( 5.7 )
    Statistical analysis title
    Comparison
    Statistical analysis description
    Independent t-test
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Secondary: Visual acuity change at 3 months

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    End point title
    Visual acuity change at 3 months
    End point description
    End point type
    Secondary
    End point timeframe
    Visual acuity change from baseline to 3 months
    End point values
    Control Active
    Number of subjects analysed
    25
    24
    Units: letters
        arithmetic mean (standard deviation)
    3.2 ( 6.3 )
    4.5 ( 5.9 )
    No statistical analyses for this end point

    Secondary: Central foveal thickness change at 3 months

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    End point title
    Central foveal thickness change at 3 months
    End point description
    End point type
    Secondary
    End point timeframe
    Central foveal thickness change from baseline to 3 months
    End point values
    Control Active
    Number of subjects analysed
    25
    24
    Units: micrometers
        arithmetic mean (standard deviation)
    -133 ( 113 )
    -186 ( 127 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    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: Adverse events were not reported.

    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/32264706
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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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