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    Clinical Trial Results:
    Triamcinolone acetonide to prevent PVR in eyes undergoing vitreoretinal surgery for open globe trauma

    Summary
    EudraCT number
    		 2007-005138-35
    Trial protocol
    		 GB  
    Global end of trial date
    30 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2019
    First version publication date
    28 Jun 2019
    Other versions
    Summary report(s)
    		 End of Study Summary Report

    Trial information

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    Trial identification
    Sponsor protocol code
    CHAD1024
    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
    Tania West (R&D office), Moorfields Eye Hospital, 020 72, moorfields.resadmin@nhs.net
    Scientific contact
    Tania West (R&D office), Moorfields Eye Hospital, 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
    01 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a pilot RCT to investigate the the effect of the use of peroperative intravitreal triamcinilone acetate in the development of proliferative vitreoretinopathy following open globe trauma.
    Protection of trial subjects
    safety and data reviewed by Moorfields internal DMC
    Background therapy
    		 Surgical repair of ocular trauma
    Evidence for comparator
    		 Eyes sustaining penetrating or open globe trauma (OGT) are a group at high risk of severe visual impairment. Retinal detachment is common in these eyes and multiple surgical interventions are often necessary 12, 13. PVR is the commonest cause of recurrent retinal detachment and visual loss in eyes with open globe trauma. It is estimated to occur in 10-45% of all OGT. 8-14 8. Cardillo JA, Stout JT, LaBree L, et al. Post-traumatic proliferative vitreoretinopathy. The epidemiologic profile, onset, risk factors, and visual outcome. Ophthalmology 1997;104(7):1166-73. 9. Spiegel D, Nasemann J, Nawrocki J, Gabel VP. Severe ocular trauma managed with primary pars plana vitrectomy and silicone oil. Retina 1997;17(4):275-85. 10. Framme C, Roider J. [Epidemiology of open globe injuries]. Klin Monbl Augenheilkd 1999;215(5):287-93. 11. Mittra RA, Mieler WF. Controversies in the management of open-globe injuries involving the posterior segment. Surv Ophthalmol 1999;44(3):215-25. 12. Stryjewski TP, Andreoli CM, Eliott D. Retinal detachment after open globe injury. Ophthalmology 2014;121(1):327-33. 13. Andreoli MT, Andreoli CM. Surgical rehabilitation of the open globe injury patient. Am J Ophthalmol 2012;153(5):856-60. 14. Desai P, MacEwen CJ, Baines P, Minassian DC. Incidence of cases of ocular trauma admitted to hospital and incidence of blinding outcome. Br J Ophthalmol 1996;80(7):592-6.
    Actual start date of recruitment
    01 Sep 2011
    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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 40 patients with open globe ocular trauma recruited between September 20111 and November 2013

    Pre-assignment
    Screening details
    		 45 patients screened for inclusion - 4 failed to meet inclusion criteria, one declined participation

    Period 1
    Period 1 title
    recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    Patient and assessor blinded Investigator - surgeon - providing treatment , (no placebo) not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 TREATMENT GROUP a. Pre-operative Treatment Guttae Prednisolone forte 2 hourly for up to one week. b. Per-operative Treatment 4mg of intravitreal triamcinolone acetonide will be injected into the vitreous cavity following injection of silicone oil at the end of procedure 40mg of triamcinolone acetonide will be given as a posterior subtenons injection prior to suturing the conjunctiva. c. Post-operative Treatment Hourly g. Predforte for 1 week followed by a tapering regimen for 3-26 weeks thereafter depending on the degree of post-operative inflammation and cystoid macular oedema. 50mg flurbiprofen orally bid for 1 week
    Arm type
    		 Experimental

    Investigational medicinal product name
    triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intraocular use
    Dosage and administration details
    Intraoperative treatment: (a) 4 mg/0.1 ml of intravitreal triamcinolone acetonide (Bristol Myers Squibb, UK) was injected into the vitreous cavity following closure of the scleral ports at the end of procedure, (b) 40 mg/1 mL of triamcinolone acetonide (Bristol Myers Squibb, UK) was administered as a posterior subtenons injection prior to suturing the conjunctiva and (c) standard subconjunctival antibiotic injection of cefuroxime 125 mg or gentamicin was administered

    Investigational medicinal product name
    prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Conjunctival use
    Dosage and administration details
    (a) Guttae prednisolone forte hourly for 1 week followed by a tapering regimen for 3–26 weeks thereafter depending on the degree of postoperative inflammation and cystoid macular oedema,

    Investigational medicinal product name
    flurbiprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg flurbiprofen orally twice daily for 1 week and

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Investigator administers treatment and there is no placebo
    Number of subjects in period 1 [2]
    		Treatment
    Started
    20
    Completed
    20
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Investigator administers treatment and sees trial medication - no placebo

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 TREATMENT GROUP a. Pre-operative Treatment Guttae Prednisolone forte 2 hourly for up to one week. b. Per-operative Treatment 4mg of intravitreal triamcinolone acetonide will be injected into the vitreous cavity following injection of silicone oil at the end of procedure 40mg of triamcinolone acetonide will be given as a posterior subtenons injection prior to suturing the conjunctiva. c. Post-operative Treatment Hourly g. Predforte for 1 week followed by a tapering regimen for 3-26 weeks thereafter depending on the degree of post-operative inflammation and cystoid macular oedema. 50mg flurbiprofen orally bid for 1 week

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 20 20
    Age categorical
    Mean age in years (SD) 44 (16) 37 (13)
    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)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    34 male and 6 female subjects recruited
    Units: Subjects
        Female
    		 2 2
        Male
    		 18 18
    Subject analysis sets

    Subject analysis set title
    treatment group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    treatment group analysed v controls

    Subject analysis set title
    control group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    analyse dv treatment group

    Subject analysis sets values
    		 treatment group control group
    Number of subjects
    20
    20
    Age categorical
    Mean age in years (SD) 44 (16) 37 (13)
    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)
    20
    20
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Mean age in years (SD) 44 (16) 37 (13)
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    34 male and 6 female subjects recruited
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 TREATMENT GROUP a. Pre-operative Treatment Guttae Prednisolone forte 2 hourly for up to one week. b. Per-operative Treatment 4mg of intravitreal triamcinolone acetonide will be injected into the vitreous cavity following injection of silicone oil at the end of procedure 40mg of triamcinolone acetonide will be given as a posterior subtenons injection prior to suturing the conjunctiva. c. Post-operative Treatment Hourly g. Predforte for 1 week followed by a tapering regimen for 3-26 weeks thereafter depending on the degree of post-operative inflammation and cystoid macular oedema. 50mg flurbiprofen orally bid for 1 week

    Subject analysis set title
    treatment group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    treatment group analysed v controls

    Subject analysis set title
    control group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    analyse dv treatment group

    Primary: The primary outcome measure was anatomic reapposition of

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    End point title
    		 The primary outcome measure was anatomic reapposition of
    End point description
    primary outcome measure The primary outcome measure was anatomic reapposition of the remaining retina to the retinal pigment epithelium in the absence of an internal tamponade agent at 6 months postprimary vitrectomy surgery
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Treatment treatment group control group
    Number of subjects analysed
    20
    20
    19
    Units: patients
    20
    20
    20
    Statistical analysis title
    		 Analysis
    Statistical analysis description
    The time taken to recruit patients is reported together with the number of patients who failed to provide outcome data. Baseline characteristics of the two groups were compared to assess the adequacy of randomisation. The OR of patients in whom anatomical retinal attachment remained at 6 months postprimary vitrectomy between the two treatment groups was reported with 95% CIs
    Comparison groups
    treatment group v control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.5 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.316
         upper limit
    		 3.904
    Variability estimate
    Standard deviation
    Dispersion value
    0.1
    Notes
    [1] - A total of 40 patients was considered a feasible number over the study period and expected to provide sufficient data to estimate the SD to power a definitive study
    [2] - Not applicable

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Period of study - 6 month follow up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    treatment
    Reporting group description
    		 The number of adverse events (AEs) was comparable across both groups with 18 out of 20 adjunct patients suffering at least one AE compared with 16 of 20 control patients. There were no cases of postoperative endophthalmitis in either group. A slightly higher number of patients in the adjunct group (n=7, 35%) suffered at least one episode of elevated intraocular pressure (IOP) (>25 mm Hg) compared with five (25%) patients in the control group. . A higher median IOP was noted in the adjunct group at day 10, but this subsequently becomes comparable between the two groups. There were more cases of postoperative uveitis in the control group (n=5) in comparison to the adjunct group (n=2). An equal number of patients (n=5) suffered at least one episode of hypotony (IOP <6 mm Hg) during the trial.

    Reporting group title
    control
    Reporting group description
    		 The number of adverse events (AEs) was comparable across both groups with 18 out of 20 adjunct patients suffering at least one AE compared with 16 of 20 control patients. There were no cases of postoperative endophthalmitis in either group. A slightly higher number of patients in the adjunct group (n=7, 35%) suffered at least one episode of elevated intraocular pressure (IOP) (>25 mm Hg) compared with five (25%) patients in the control group. The median IOP readings at each time point is displayed in the box plot of figure 3. A higher median IOP was noted in the adjunct group at day 10, but this subsequently becomes comparable between the two groups. There were more cases of postoperative uveitis in the control group (n=5) in comparison to the adjunct group (n=2). An equal number of patients (n=5) suffered at least one episode of hypotony (IOP <6 mm Hg) during the trial.

    Serious adverse events
    		 treatment control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    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
    18 / 20 (90.00%)
    13 / 20 (65.00%)
    Eye disorders
    raised iop
    Additional description: raised intraocular pressure
         subjects affected / exposed
    18 / 20 (90.00%)
    13 / 20 (65.00%)
         occurrences all number
    18
    13

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26546051
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