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    Clinical Trial Results:
    A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa

    Summary
    EudraCT number
    		 2016-002523-28
    Trial protocol
    		 GB  
    Global end of trial date
    20 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Mar 2019
    First version publication date
    14 Mar 2019
    Other versions
    Summary report(s)
    		 Suspended - no results

    Trial information

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    Trial identification
    Sponsor protocol code
    KHAK1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Moorfields Eye Hospital NHS Foundation Trust
    Sponsor organisation address
    162 City Road, London, United Kingdom, EC1V 2PD
    Public contact
    Natasha Ajraam, R&D, Moorfields Eye Hospital, 020 72533411, natasha.ajraam@moorfields.nhs.uk
    Scientific contact
    Natasha Ajraam, R&D, Moorfields Eye Hospital, 020 72533411, natasha.ajraam@moorfields.nhs.uk
    Sponsor organisation name
    Moorfields Eye Hospital NHS Foundation Trust
    Sponsor organisation address
    162 City Road, London, United Kingdom, EC1V 2PD
    Public contact
    Natasha Ajram , Natasha Ajram Moorfields Eye Hospital, 162 City Road, London, 020 72533411, moorfields.resadmin@nhs.net
    Scientific contact
    Natasha Ajram , Natasha Ajram Moorfields Eye Hospital, 162 City Road, London, 020 72533411, moorfields.resadmin@nhs.net
    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 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1. To describe the anatomical and functional changes occurring in treated and control eyes over a 36-month period. Technical outcome measures = OCT: (1) Change in area of ellipsoid zone integrity (mm2) at the macula. (2) Change in outer retinal thickness across the macula. (3) Change in subfoveal choroidal thickness (mm). FAF: (1) Change in area demonstrating “loss of AF” on standard 55° macula centred image (mm2). (2) Area within the ring of hyperautofluorescence (mm2). Visual Field: Change in size of V4e isopter area.
    Protection of trial subjects
    No patients recruited - study was suspended prior to any recruitment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    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
    United Kingdom: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No recruitment - study was suspended prior to any recruitment. 1 patient entered as recruited to satisfy data entry reporting for database.

    Pre-assignment
    Screening details
    		 No patients screened.

    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
    		 immunosuppressive therapeutic
    Arm description
    		 Administration of Iluvien
    Arm type
    		 Implant for intravitreal injection

    Investigational medicinal product name
    Illuvin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravitreal implant in applicator
    Routes of administration
    Ocular use
    Dosage and administration details
    Synthetic corticosteroid derivative. Fluocinolone acetonide is a white or almost white, microcrystalline powder, practically insoluble in water, soluble in methanol, ethanol, chloroform and acetone, and sparingly soluble in ether.

    Number of subjects in period 1
    		immunosuppressive therapeutic
    Started
    1
    Completed
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    immunosuppressive therapeutic
    Reporting group description
    		 Administration of Iluvien

    Primary: anatomical and functional changes occurring in treated and control eyes

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    End point title
    		 anatomical and functional changes occurring in treated and control eyes [1]
    End point description
    End point type
    Primary
    End point timeframe
    36 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: none specified as trial was suspended - no patients recruited.
    End point values
    		 immunosuppressive therapeutic
    Number of subjects analysed
    1 [2]
    Units: months
        number (not applicable)
    1
    Notes
    [2] - no patients recruited
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    as per protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    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: none specified as trial was suspended - no patients recruited.

    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
    For support, Contact us.
    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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