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    Clinical Trial Results:
    Intravitreal ranibizumab in patients with retinal pigment epithelial detachments secondary to AMD

    Summary
    EudraCT number
    		 2008-004675-22
    Trial protocol
    		 DE  
    Global end of trial date
    22 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions
    Summary report(s)
    		 Manuscript - Monthly IVL in PED

    Trial information

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    Trial identification
    Sponsor protocol code
    ADM-PED08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00976222
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Bonn
    Sponsor organisation address
    Sigmund-Freud-Str. 25, Bonn, Germany, 53105
    Public contact
    Klinisches Studienzentrum, Universitätsklinikum Münster, Klinik für Augenheilkunde, 49 2518356048, augenklinik-studien@ukmuenster.de
    Scientific contact
    Klinisches Studienzentrum, Universitätsklinikum Münster, Klinik für Augenheilkunde, 49 2518356048, augenklinik-studien@ukmuenster.de
    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
    31 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD
    Protection of trial subjects
    The study medication has already been authorized for the treatment of age related macula degeneration. The investigator informed the patient about the study in detail and both undersigned the informed consent form. A patient insurance was in place. Adverse events were documented regularly. As needed and at the discretion of the ophthalmologist all patients could also be treated with Verteprofin within the scope of photodynamic therapy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2008
    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
    Germany: 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)
    5
    From 65 to 84 years
    33
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Informed consent has to be signed and Inclusion/Exclusion criteria must match. The study medication can be administered at baseline visit in consideration of the clinical investigation as well as imaging processes.

    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
    		 Ranibizumab
    Arm description
    		 Every study patient was treated with Ranibizumab 0,5
    Arm type
    		 single arm

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intraocular instillation solution
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients were treated monthly with intravitreal 0.5 mg ranibizumab injections

    Number of subjects in period 1
    		Ranibizumab
    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)
    		 5 5
        From 65-84 years
    		 33 33
        85 years and over
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who were enrolled

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    40
    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)
    5
        From 65-84 years
    33
        85 years and over
    2
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    23
        Male
    17

    End points

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    End points reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 Every study patient was treated with Ranibizumab 0,5

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who were enrolled

    Primary: Mean BCVA

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    End point title
    		 Mean BCVA [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline - Month 12
    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: See attachment
    End point values
    		 Ranibizumab
    Number of subjects analysed
    40
    Units: whole
    40
    Attachments
    		 Manuscript - Monthly IVL in PED
    No statistical analyses for this end point

    Primary: Decrease in PED height

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    End point title
    		 Decrease in PED height [2]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline - Month12
    Notes
    [2] - 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: See attachment
    End point values
    		 Ranibizumab
    Number of subjects analysed
    40
    Units: whole
    40
    Attachments
    		 Manuscript - Monthly IVL in vPED
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to completion visit (4 weeks after last administration of study medication)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Bonn/Münster
    Reporting group description
    		 All patients receiving at least one time study medication

    Reporting group title
    Munich
    Reporting group description
    		 All patients receiving at least one time study medication

    Serious adverse events
    		 Bonn/Münster Munich
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Cerebral microangiopathy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Basaliom
    Additional description: Non-study eye
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hospitalisation
    Additional description: Hospitalisation due to radioiodine therapy for thyroid hyperfunction
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bonn/Münster Munich
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    Blood and lymphatic system disorders
    Increased blood pressure
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    1
    foot edema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Immune system disorders
    Pollen allergy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye disorders
    hyposphagma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Common cold
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    1

    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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