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    Clinical Trial Results:
    A phase 3 multi-centre double-masked randomised controlled trial of adjunctive intraocular and periocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma; the adjunctive steroid combination in ocular trauma (ASCOT) trial

    Summary
    EudraCT number
    		 2014-002193-37
    Trial protocol
    		 GB  
    Global end of trial date
    30 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2021
    First version publication date
    01 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHAD1031
    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
    Hayley Boston, Moorfields Eye Hospital NHS Foundation Trust, 0044 20 7253 3411 x2937 , moorfields.resadmin@nhs.net
    Scientific contact
    Daniela Narvaez, Moorfields Eye Hospital NHS Foundation Trust, 207253341 020 7253 3411 x2937 , 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
    17 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In patients who have sustained an open globe injury (severe trauma) and are undergoing vitrectomy surgery as a result(procedure to clear the gel in the back of the eye) , does the use of a steroid injection into and around the eye improve the visual outcome at 6 months?
    Protection of trial subjects
    Trial subjects were able to access the trial team and raise any issues. trail subjects were seen and dealt with promptly by hospital vitreoretinal services which are configured to manage acute and urgent situations.
    Background therapy
    		 Standard vitreoretinal surgical care for penetrating eye injuries.
    Evidence for comparator
    		 Multiple publications on vitreoretinal surgical outcomes in trauma: Desai, P., et al., Incidence of cases of ocular trauma admitted to hospital and incidence of blinding outcome. Br J Ophthalmol, 1996. 80(7): p. 592-6. Pinna, A., et al., Epidemiology, visual outcome, and hospitalization costs of open globe injury in northern Sardinia, Italy. Ophthalmic Epidemiol, 2007. 14(5): p. 299-305. Cillino, S., et al., A five-year retrospective study of the epidemiological characteristics and visual outcomes of patients hospitalized for ocular trauma in a Mediterranean area. BMC Ophthalmol, 2008. 8: p. 6. Cardillo, J.A., et al., Post-traumatic proliferative vitreoretinopathy. The epidemiologic profile, onset, risk factors, and visual outcome. Ophthalmology, 1997. 104(7): p. 1166-73. Spiegel, D., et al., Severe ocular trauma managed with primary pars plana vitrectomy and silicone oil. Retina, 1997. 17(4): p. 275-85. Framme, C. and J. Roider, [Epidemiology of open globe injuries]. Klin Monbl Augenheilkd, 1999. 215(5): p. 287-93. Mittra, R.A. and W.F. Mieler, Controversies in the management of open-globe injuries involving the posterior segment. Surv Ophthalmol, 1999. 44(3): p. 215-25.
    Actual start date of recruitment
    01 Oct 2014
    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: 280
    Worldwide total number of subjects
    280
    EEA total number of subjects
    0
    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)
    220
    From 65 to 84 years
    45
    85 years and over
    15

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of 280 cases took place between December 2014 and March 2020

    Pre-assignment
    Screening details
    		 792 patient screened

    Period 1
    Period 1 title
    Recruitment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 Intra0cular and sub Tenons triamcinolone acetonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Kenolog
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subconjunctival use, Intraocular use
    Dosage and administration details
    steroid combination (triamcinolone acetonide) - 4mg/0.1ml into the vitreous cavity and 40mg/1ml subtenons given at the end of vitreoretinal surgery

    Arm title
    		 Control
    Arm description
    		 Standard vitreoretinal surgery
    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
    143
    137
    Completed
    130
    129
    Not completed
    13
    8
         Consent withdrawn by subject
    2
    1
         Lost to follow-up
    7
    7
         Protocol deviation
    4
    -
    Period 2
    Period 2 title
    Follow up and end point
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 Intra0cular and sub Tenons triamcinolone acetonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Kenolog
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subconjunctival use, Intraocular use
    Dosage and administration details
    steroid combination (triamcinolone acetonide) - 4mg/0.1ml into the vitreous cavity and 40mg/1ml subtenons given at the end of vitreoretinal surgery

    Arm title
    		 Control
    Arm description
    		 Standard vitreoretinal surgery
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Treatment Control
    Started
    130
    129
    Completed
    130
    129

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Recruitment
    Reporting group description
    		 -

    Reporting group values
    		 Recruitment Total
    Number of subjects
    		 280 280
    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
    Median age 43 years IQR 30 to 55 years
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 43 (30 to 55) -
    Gender categorical
    Units: Subjects
        Male
    		 246 246
        Female
    		 34 34

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Intra0cular and sub Tenons triamcinolone acetonide

    Reporting group title
    Control
    Reporting group description
    		 Standard vitreoretinal surgery
    Reporting group title
    Treatment
    Reporting group description
    		 Intra0cular and sub Tenons triamcinolone acetonide

    Reporting group title
    Control
    Reporting group description
    		 Standard vitreoretinal surgery

    Primary: Clinically meaningful change in visual acuity

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    End point title
    		 Clinically meaningful change in visual acuity
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Treatment Control
    Number of subjects analysed
    130
    129
    Units: Nunber of particupants
    61
    57
    Statistical analysis title
    		 Mixed logistic regression model
    Comparison groups
    Treatment v Control
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.994
    Method
    		 Regression, Linear
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.68

    Secondary: Change in visual acuity - continuous

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    End point title
    		 Change in visual acuity - continuous
    End point description
    Visual acuity change as a continuous measure
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment Control
    Number of subjects analysed
    130
    129
    Units: ETDRS letters
        number (not applicable)
    19.4
    19.3
    Statistical analysis title
    		 Linear mixed regression model
    Comparison groups
    Treatment v Control
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.361
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.67
         upper limit
    		 3.52

    Secondary: Stable complete retinal reattachment (without internal tamponade present) at 6 months

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    End point title
    		 Stable complete retinal reattachment (without internal tamponade present) at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment Control
    Number of subjects analysed
    126
    123
    Units: Number of paticipants
    65
    79
    Statistical analysis title
    		 Mixed logistic regression model
    Comparison groups
    Treatment v Control
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.99

    Secondary: Retinal detachment with PVR within 6 months of vitrectomy

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    End point title
    		 Retinal detachment with PVR within 6 months of vitrectomy
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment Control
    Number of subjects analysed
    124
    124
    Units: number of participants
    42
    35
    Statistical analysis title
    		 Mixed logistic regression model
    Comparison groups
    Treatment v Control
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.327
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.27

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months after trial finished recruitment
    Adverse event reporting additional description
    Adverse events were recorded with clinical symptoms and accompanied with a simple, brief description of the event, including dates as appropriate. Adverse events were reported on the eCRF. Serious adverse events were reported in an expedited manner to the Sponsor for each participant for their duration in the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Intra0cular and sub Tenons triamcinolone acetonide

    Reporting group title
    Control
    Reporting group description
    		 Standard vitreoretinal surgery

    Serious adverse events
    		 Treatment Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 130 (3.85%)
    0 / 129 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Eye disorders
    Central subretinal bleed
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elevated intraocular pressure
         subjects affected / exposed
    2 / 130 (1.54%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    loss of eye
    Additional description: due to the effects of injury
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 130 (62.31%)
    66 / 129 (51.16%)
    Eye disorders
    Elevated intraocular pressure
         subjects affected / exposed
    56 / 130 (43.08%)
    45 / 129 (34.88%)
         occurrences all number
    56
    45
    Retinal detachment
         subjects affected / exposed
    28 / 130 (21.54%)
    21 / 129 (16.28%)
         occurrences all number
    28
    21
    uveitis
         subjects affected / exposed
    6 / 130 (4.62%)
    2 / 129 (1.55%)
         occurrences all number
    6
    2
    endophthalmitis
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 129 (0.00%)
         occurrences all number
    1
    0
    hypotony
    Additional description: low intraocular pressure
         subjects affected / exposed
    29 / 130 (22.31%)
    35 / 129 (27.13%)
         occurrences all number
    29
    35

    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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