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    Clinical Trial Results:
    Intravitreal Aflibercept treatment in RAP-Lesions, PED, hemorrhagic CNV and PCV

    Summary
    EudraCT number
    		 2014-002384-15
    Trial protocol
    		 AT  
    Global end of trial date
    30 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2019
    First version publication date
    16 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    MUW, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, +43 14040079310, stefan.sacu@meduniwien.ac.at
    Scientific contact
    MUW, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, +43 14040079310, 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
    Interim
    Date of interim/final analysis
    02 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of intravitreal Aflibercept treatment on the visual outcome in patient with exsudative maculopathies such as Rap-lesions, PED, hemorrhagic CNV and PCV.
    Protection of trial subjects
    Intravitreal aflibercept therapy is considered to be safe. As with every intravitreal form of therapy, the potential for post-injection IOP elevation, endophthalmitis, cataract, hemorrhage, rhegmatogenous retinal detachment or proliferative vitreoretinopathy must be considered. However, all of these side effects have an incidence of less than 1% of all treatments. After intravitreal injections, visual acuity of patient will be checked (e.g. hand motion, counting fingers) to avoid unacceptable IOP elevations and ensure ocular perfusion-in cases of blocked ocular perfusion (i.e. the patient is unable to recognize hand motion/finger counting), a paracentesis will be performed by the surgeon
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 2014
    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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    3
    From 65 to 84 years
    35
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Fifty patients will be enrolled in the study. The population will consist patients over 50 years of age with treatment naïve, RAP-lesions, PED, hemorrhagic CNV and polypoidal choroidal vasculopathy.

    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
    		 Evaluation of intravitreal aflibercept (Eylea®, Bayer) on oxygen saturatin and clinical outcomes in eyes with RAP-lesions, PED, hemorrhagic CNV or PCV.
    Arm type
    		 Intervention

    Investigational medicinal product name
    Intravitreal aflibercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2mg/0.05ml

    Number of subjects in period 1
    		All Patients
    Started
    50
    Completed
    43
    Not completed
    7
         Lost to follow-up
    7

    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
    		 50 50
    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 (full range (min-max))
    		 77 (60 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    All Patients
    Reporting group description
    		 Evaluation of intravitreal aflibercept (Eylea®, Bayer) on oxygen saturatin and clinical outcomes in eyes with RAP-lesions, PED, hemorrhagic CNV or PCV.

    Primary: Oxygen saturation of retinal vessels

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    End point title
    		 Oxygen saturation of retinal vessels [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 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: Anova and the paired t-test was performed to investigate the longitudinal changes in visual acuity, the central retinal thickness, 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
    50
    Units: Percentage
    95
    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 are 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
    Aflibercept
    Reporting group description
    		 ntravitreal aflibercept treatment will be performed identically under sterile conditions in the surgery room as follows: 0,5ml of 2 mg of commercially available aflibercept (Eylea®; Bayer) will be applied intravitreal through the pars plana using a 30-gauge needle

    Serious adverse events
    		 Aflibercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 50 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Palate cancer
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Apoplexy
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pacemaker
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Hemorrhage
    Additional description: Visual reduction due to new hemorraghe
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Mastectomy
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Aflibercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 50 (10.00%)
    Nervous system disorders
    Polyneuropathy
    Additional description: Polyneuropathy legs
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Eye disorders
    Visual acuity reduced
    Additional description: Visual loss due to increase of SRF and PED
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Cataract operation
    Additional description: Cataract operation both eyes
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Infections and infestations
    Antibiotic therapy
    Additional description: Antibiotic Dalcin
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    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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