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    Clinical Trial Results:
    Intravitreal Lucentis (Ranibizumab) in acute central serous Chrioretinopathy - a prospective, randomized, single blind monocentric study

    Summary
    EudraCT number
    		 2010-020902-13
    Trial protocol
    		 AT  
    Global end of trial date
    04 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2021
    First version publication date
    02 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0001-2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    RCS Studie, Chefsekretariat, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Innsbruck, +43 51250423720, bernhard.steger@i-med.ac.at
    Scientific contact
    RCS Studie, Chefsekretariat, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Innsbruck, +43 51250423720, bernhard.steger@i-med.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 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To test the safety and efficacy of intravitreal injections with Lucentis (Ranibizumab) in acute onset CSC. Primary outcome measure is the resolution of neurosensory detachment as measured by optic coherence tomography six months after study inclusion.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2011
    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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No patients were recruited for this trial. "99999" is a value for 0 participants.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Lucentis/ Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Ranibizumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects would have received intravitreal injection of 0.5mg (0.05mL) Lucentis under sterile conditions up to three times during the whole trial.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Other use
    Dosage and administration details
    Subjects would have received a "sham-injection" of 0.05mL placebo under sterile conditions up to three times during the whole trial.

    Number of subjects in period 1
    		Lucentis/ Placebo
    Started
    99999
    Completed
    99999

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 99999 99999
    Age categorical
    No patients were enrolled in this trial. "99999" is a value for 0 participants.
    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)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    No patients were enrolled in this trial. "99999" is a value for 0 participants.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    No patients were enrolled in this trial. "99999" is a value for 0 participants.
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Lucentis/ Placebo
    Reporting group description
    		 -

    Primary: Neurosensory detachment

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    End point title
    		 Neurosensory detachment [1]
    End point description
    Primary outcome measure is the resolution of neurosensory detachment as measured by optic coherence tomography six months after study inclusion.
    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: No subjects were enrolled in this trial, therefore no statistical analysis was done.
    End point values
    		 Lucentis/ Placebo
    Number of subjects analysed
    99999 [2]
    Units: µm
        number (not applicable)
    99999
    Notes
    [2] - No subjects were recruited for this trial. " 99999" is a value for 0 participants.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    01.07.2011- 04.09.2014
    Adverse event reporting additional description
    No patients were included in this trial, therefore no AEs or SAEs were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Lucentis/ Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Lucentis/ Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (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
    		 Lucentis/ Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    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 subjects were enrolled in this trial, therefore no AEs or SAEs were observed.

    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.
    No subjects were enrolled in this trial. "99999" is a value for 0 participants , as it was not possible to fill in "0" for the number of included patients.
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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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