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    Clinical Trial Results:
    Ozurdex in proliferative vitreoretinopathy; a randomised control trial

    Summary
    EudraCT number
    		 2011-004498-96
    Trial protocol
    		 GB  
    Global end of trial date
    31 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Oct 2020
    First version publication date
    03 Oct 2020
    Other versions
    Summary report(s)
    		 End of study report

    Trial information

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    Trial identification
    Sponsor protocol code
    CHAD1030
    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
    City Road, London, United Kingdom, EC1V 2PD
    Public contact
    Ms Nicola Harris Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital NHS Foundation Trust, 0044 2072533411, nicola.harris@moorfields.nhs.uk
    Scientific contact
    Mr David Charteris Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital NHS Foundation Trust, 0044 2072533411, david.charteris@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
    08 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does the use of an additional anti inflammatory agent (ozurdex) given at the time of surgery in patients with established PVR (scar tissue on the retina)result in an improved surgical outcome at 6 months after the surgery?
    Protection of trial subjects
    Nil specific
    Background therapy
    		 Standard post-operative regime with topical dexamethasone qid and topical chaloamphenicaol qid
    Evidence for comparator
    		 Complete primary success in 51% of subjects in previous RCT at study centre Charteris DG, Aylward GW, Wong D, Groenewald C, Asaria RHY, Bunce C A randomised controlled trial of combined 5-fluorouracil and low molecular weight heparin in management of established proliferative vitreoretinopathy Ophthalmology. 2004 111:2240-5
    Actual start date of recruitment
    31 Oct 2011
    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: 140
    Worldwide total number of subjects
    140
    EEA total number of subjects
    140
    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)
    115
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment went as planned at the study centre - 140 subjects

    Pre-assignment
    Screening details
    		 192 subjects were screed for eligibility. Of these 29 did not meet the inclusion criteria, 20 were eligible but not enrolled and 3 were enrolled but not randomised (silicone oil not used in surgery)

    Pre-assignment period milestones
    Number of subjects started
    		 140
    Number of subjects completed
    		 140

    Period 1
    Period 1 title
    Recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The operating surgeon was not blinded as the treatment (steroid implant) is obvious at the time of surgery The subject and trial are blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 0.7-mg slow-release dexamethasone implant given at completion of surgery and at oil removal (approximately 3 months later) Standard per-operative (subconjunctival betamethasone and cefuroxime) and post operative (tapering topical dexamethasone and chloramphenicol) given
    Arm type
    		 Experimental

    Investigational medicinal product name
    Slow release dexamenthasone implant
    Investigational medicinal product code
    Other name
    Ozurdex
    Pharmaceutical forms
    Implant
    Routes of administration
    Intraocular use
    Dosage and administration details
    0.7mg given into the vitreous cavity with silicone oil

    Arm title
    		 Control
    Arm description
    		 Standard per operative and post operative medications given (sub conjunctival betamethasone and cefuroxime and tapering post-operative dexamethasone and chloramphenicol)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Treatment Control
    Started
    70
    70
    Completed
    69
    69
    Not completed
    1
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 0.7-mg slow-release dexamethasone implant given at completion of surgery and at oil removal (approximately 3 months later) Standard per-operative (subconjunctival betamethasone and cefuroxime) and post operative (tapering topical dexamethasone and chloramphenicol) given

    Reporting group title
    Control
    Reporting group description
    		 Standard per operative and post operative medications given (sub conjunctival betamethasone and cefuroxime and tapering post-operative dexamethasone and chloramphenicol)

    Reporting group values
    		 Treatment Control Total
    Number of subjects
    		 70 70 140
    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 (standard deviation)
    		 60.6 ± 14.3 61.6 ± 13.9 -
    Gender categorical
    By patient group
    Units: Subjects
        Female
    		 24 30 54
        Male
    		 46 40 86
    ETDRS visual acuity
    Units: Subjects
        ETDRS VA
    		 70 70 140
    PVR grade
    Grade of PVR
    Units: clock hours,
        median (inter-quartile range (Q1-Q3))
    		 3 (2 to 4) 4 (2 to 6) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 0.7-mg slow-release dexamethasone implant given at completion of surgery and at oil removal (approximately 3 months later) Standard per-operative (subconjunctival betamethasone and cefuroxime) and post operative (tapering topical dexamethasone and chloramphenicol) given

    Reporting group title
    Control
    Reporting group description
    		 Standard per operative and post operative medications given (sub conjunctival betamethasone and cefuroxime and tapering post-operative dexamethasone and chloramphenicol)

    Primary: primary, stable retinal reattachment

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    End point title
    		 primary, stable retinal reattachment
    End point description
    assessed clinically
    End point type
    Primary
    End point timeframe
    6 months after recruitment
    End point values
    		 Treatment Control
    Number of subjects analysed
    69
    69
    Units: subjects
    49
    46
    Statistical analysis title
    		 primary outcome
    Comparison groups
    Control v Treatment
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From recruitment start February 2012 to final follow up - February 2015
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2004
    Reporting groups
    Reporting group title
    treatment
    Reporting group description
    		 -

    Reporting group title
    control
    Reporting group description
    		 -

    Serious adverse events
    		 treatment control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 70 (10.00%)
    6 / 69 (8.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Eye disorders
    suture related abscess
    Additional description: non-IMP related infection, all other SAEs were suystemic , non-fatal and not related to the IMP
         subjects affected / exposed [1]
    7 / 7 (100.00%)
    6 / 6 (100.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The numbers are equal
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 treatment control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 70 (94.29%)
    63 / 69 (91.30%)
    Eye disorders
    raised intraocular pressure
    Additional description: Most common AE was raised IOP -
         subjects affected / exposed [2]
    66 / 66 (100.00%)
    63 / 63 (100.00%)
         occurrences all number
    66
    63
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The numbers are equal

    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.
    Retrospective

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28237428
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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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