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    Clinical Trial Results:
    Aflibercept (Eylea®) for macular oedema associated with underlying Retinitis Pigmentosa (AMOUR)

    Summary
    EudraCT number
    		 2015-003723-65
    Trial protocol
    		 GB  
    Global end of trial date
    20 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2019
    First version publication date
    20 Jun 2019
    Other versions
    Summary report(s)
    		 Final study report

    Trial information

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    Trial identification
    Sponsor protocol code
    MICM1014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02661711
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Moorfields Eye Hospital
    Sponsor organisation address
    162 City Road, London, United Kingdom, EC1V 2PD
    Public contact
    Gisela Barreto, Moorfields Eye Hospital, +44 02072533411, gisela.barreto@moorfields.nhs.uk
    Scientific contact
    Gisela Barreto, Moorfields Eye Hospital, +44 02072533411, gisela.barreto@moorfields.nhs.uk
    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
    20 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To report mean Central Macular Thickness (CMT) at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.
    Protection of trial subjects
    Non-study eye was treated in accordance with NHS standards of care and was monitored throughout the study.
    Background therapy
    		 Patients stopped topical and/or oral treatment for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) in the study eye whilst undertaking this study. Topical treatment in the non-study eye could be continued throughout the study if the patient wished to continue this.
    Evidence for comparator
    		 The study drug was not compared to another drug during this trial
    Actual start date of recruitment
    14 Mar 2016
    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
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients will be recruited over a 6 to 12 month period. Within a week of being approached in the medical retina clinics or by telephone and having been provided with information about the trial, our research manager will contact the patient and invite them to attend a screening appointment.

    Pre-assignment
    Screening details
    		 130 patients were found to be suitable participants. 18 could not be contacted, 1 was deceased, 32 wished to be considered for the study, and 79 others declined for various reasons.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Intravitreal aflibercept for RP-CMO
    Arm description
    		 Intravitreal aflibercept for RP-CMO
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aflibercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Eylea solution is supplied in a vial (40mg/ml). Each vial contains 100 microlitres, equivalent to 4 mg aflibercept. This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept. The dose used in this trial will be 0.05ml (2mg) per intravitreal injection.

    Number of subjects in period 1
    		Intravitreal aflibercept for RP-CMO
    Started
    30
    Completed
    29
    Not completed
    1
         Did not wish to continue in the study
    1

    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
    		 30 30
    Age categorical
    All patients in the trial were aged between 18 -64 years
    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)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Overall cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The overall cohort

    Subject analysis set title
    Responders
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients who were deemed as 'responders'

    Subject analysis sets values
    		 Overall cohort Responders
    Number of subjects
    30
    11
    Age categorical
    All patients in the trial were aged between 18 -64 years
    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)
    30
    11
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    13
    3
        Male
    17
    8

    End points

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    End points reporting groups
    Reporting group title
    Intravitreal aflibercept for RP-CMO
    Reporting group description
    		 Intravitreal aflibercept for RP-CMO

    Subject analysis set title
    Overall cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The overall cohort

    Subject analysis set title
    Responders
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients who were deemed as 'responders'

    Primary: Mean central macular thickness (CMT) on Spectral domain OCT (SDOCT) at 12 months after baseline

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    End point title
    		 Mean central macular thickness (CMT) on Spectral domain OCT (SDOCT) at 12 months after baseline [1]
    End point description
    To report the efficacy of aflibercept in RP-CME via mean central macular thickness (CMT) on Spectral domain OCT (SDOCT) at 12 months after baseline.
    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: Only descriptive statistics were used for this study
    End point values
    		 Overall cohort Responders
    Number of subjects analysed
    Units: Microns
    413
    350
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Bayer plc., 2015
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Serious adverse event
    Reporting group description
    		 -

    Serious adverse events
    		 Serious adverse event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Eye disorders
    Sub-acute reduction of vision
    Additional description: Reduction in vision most likely secondary to progression of underlying retinitis pigmentosa rather than as a consequence of ivA
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Serious adverse event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 30 (83.33%)
    Eye disorders
    Ocular adverse events
    Additional description: These included: floater, sub-conjunctival haemorrhage, blurring of vision, corneal epithelial defect, dry cornea, chalazion, grittiness, raised intra-ocular pressure, corneal abrasion and soreness.
         subjects affected / exposed
    25 / 30 (83.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2015
    We requested to analyse data at 6 months as well as at 12 months

    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.
    N/A
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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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