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    Summary
    EudraCT Number:2014-002193-37
    Sponsor's Protocol Code Number:CHAD1031
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-07-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-002193-37
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the potential of an intensive anti-inflammatory treatment regime to improve the outcome of surgery in eyes that have suffered severe trauma.
    A.3.2Name or abbreviated title of the trial where available
    Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study
    A.4.1Sponsor's protocol code numberCHAD1031
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMoorfields Eye Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMoorfields Eye Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointNatasha Ajraam
    B.5.3 Address:
    B.5.3.1Street AddressMoorfields Eye Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1V 2PD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 7253 3411 x2937
    B.5.6E-mailnatasha.ajraam@moorfields.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kenalog
    D.2.1.1.2Name of the Marketing Authorisation holderE.R Squibb and Sons
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKenalog
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Intraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriamcinolone Acetonide
    D.3.9.1CAS number 76-25-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    retinal detachment and the development of scarring (proliferative vitreoretinopathy) in patients with open globe trauma
    E.1.1.1Medical condition in easily understood language
    eyes that have suffered severe trauma due to undergo surgery to back of eye
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10057896
    E.1.2Term Proliferative vitreoretinopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10038848
    E.1.2Term Retinal detachment
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main 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?
    E.2.2Secondary objectives 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
    (a) reduce the proportion of patients in whom retinal detachment with scarring occurs at any timepoint within 6 months of the study surgery
    (b) increase the proportion of patients in whom stable complete retinal reattachment is achieved at 6 months post study surgery
    (c) increase the proportion of patients in whom stable central retinal reattachmen is achieved at 6 months post study surgery
    (d) decrease the proportion of patients in whom a tractional retinal detachment (no retinal hole) occurs at any timepoint within 6 months of the study surgery
    (e) reduce the number of operations required to achieve stable retinal reattachment (either complete or central) at 6 months after the study surgery
    (f) reduce the proportion of patients who suffer hypoton
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Adjuncts in Ocular Trauma (AOT Trial)
    From September 2011 - November 2013
    (A pilot study using the same IMP in the target sample population to investigate any trends towards a treatment effect and power this definitive trial)
    E.3Principal inclusion criteria
    1. Adult subjects (Aged 18 years or over at the time of enrolment)
    2. Full thickness, open-globe ocular trauma undergoing vitrectomy
    3. Ability to give written informed consent
    4. Willingness to accept randomization and attend follow-up for 6 months.
    E.4Principal exclusion criteria
    1. Children (Age less than 18 years old at time of enrollment)
    2. Pre-existing uncontrolled uveitis (This does not include patients whose uveitis is secondary to their injury or retinal detachment)
    3. Definitive diagnosis of previous steroid induced glaucoma – (this does not include patients in whom a query of previous steroid-induced raised IOP has been postulated)
    4. Pregnant or Breastfeeding females (Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after completion of the trial. Females of childbearing potential must have a negative urinary pregnancy test within 7 days prior to being registered for trial treatment (Subjects are considered not of child bearing potential if they are permanently sterile (i.e. they have undergone a hysterectomy, bilateral tubal occlusion, or bilateral salpingectomy) or they are postmenopausal).
    5. Allergy or previous known adverse reaction to triamcinolone acetonide
    6. Inability to attend regular follow up.
    7. Unable to give written informed consent.
    8. Current or planned systemic corticosteroid use of a dose above physiological levels (e.g. >10mg prednisolone)
    E.5 End points
    E.5.1Primary end point(s)
    Dual primary outcome
    1) Corrected visual acuity score (ETDRS letter score) at 6 months after initial study surgery
    2) Proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity (ETDRS letter score)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time-points of evaluation will be undertaken at baseline (prior to initial study surgery), three months after initial surgery and six months after initial surgery.
    E.5.2Secondary end point(s)
    To determine whether adjunctive intraocular and periocular steroid (triamcinolone acetonide) influences the development of scarring (proliferative vitreoretinopathy), retinal detachment, intraocular pressure abnormalities and other complications in eyes undergoing surgery for open globe trauma. In addition to assess the effects of treatment on quality of life measured using the EQ-5D, VFQ25 tools
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time-points of evaluation will be undertaken at baseline (prior to initial study surgery), three months after initial surgery and six months after initial surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prmary outcome assessor masked/particpant masked/operating surgeon masked(until time IMP admin)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Return to standard NHS care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-05
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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