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    Summary
    EudraCT Number:2015-000468-33
    Sponsor's Protocol Code Number:RC15_0056
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-24
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-000468-33
    A.3Full title of the trial
    Comparaison de l’efficacité et de la tolérance d’une injection sous-conjonctivale de triamcinolone et d’un implant intravitréen de dexaméthasone sur l’œdème maculaire inflammatoire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TRIOZ
    A.3.2Name or abbreviated title of the trial where available
    TRIOZ
    A.4.1Sponsor's protocol code numberRC15_0056
    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 SponsorCHU de Nantes
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDépartement Promotion
    B.5.3 Address:
    B.5.3.1Street Address5 alée de l'île Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number033253482835
    B.5.5Fax number033253482836
    B.5.6E-maillaetitia.biron@chu-nantes.fr
    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 Kénacort Retard
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameKénacort Retard
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubconjunctival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONE ACETONIDE
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ozurdex 700µg, implant intravitréen avec applicateur
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameOzurdex 700µg, implant intravitréen avec applicateur
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number700
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients atteints d’œdème maculaire inflammatoire
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation de l’efficacité d’une injection sous-conjonctivale de 16 mg de triamcinolone sur la réduction de l’épaisseur maculaire centrale mesurée en OCT par rapport à un implant intravitréen de 700µg de dexaméthasone entre la sélection et M2 (2 mois après le traitement).
    E.2.2Secondary objectives of the trial
    •Evaluation du vécu de l’injection par un questionnaire (tolérable, désagréable et très désagréable) et par EVA (0cm = pas douleur à 10cm = douleur extrême)

    •Evaluation de l’efficacité de l’injection étudiée à chaque visite au niveau :
    -Du gain d’acuité visuelle (EDTRS), paramètre fonctionnel visuel déterminant
    -De la réduction du Tyndall protéique antérieur et vitréen, paramètres inflammatoires oculaires quantifiables
    -De l’épaisseur maculaire centrale mesurée par OCT permettant l’évaluation de la durée d’action d'une injection sous-conjonctivale de triamcinolone par rapport à une injection d’un implant intravitréen de 700µg de dexaméthasone La durée d’action de l’injection est déterminée par la réapparition de l’oedème
    -De la tolérance locale et générale, en recueillant tous les EI/EIG.
    -De la qualité de vie des patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient, homme ou femme (sous contraception efficace si non ménopausée) de plus de 18 ans
    -Patient affilié à un régime de Sécurité Sociale
    -Patient apte à comprendre et à suivre les instructions de l’étude
    -Patient ayant signé un consentement éclairé
    -Patient ayant une épaisseur maculaire centrale (1000 µm centraux) de plus de 320µm (Spectral Domain , 270µm Time Domain)
    -Patient ayant un œdème maculaire inflammatoire uni- ou bilatéral asymétrique (pour le cas d’un œdème maculaire inflammatoire bilatéral l’œil le plus touché sera traité)
    E.4Principal exclusion criteria
    - Patient ayant une uvéite infectieuse
    - Patients VIH positif ou affecté par l’Hépatite B ou C (VHB VHC), la syphilis (TPHA-VDRL) ou la tuberculose (Quantiféron)
    - Patient recevant un traitement général anti-inflammatoire et/ou immunosuppresseur et/ou immunomodulateur qui n'a pas été modifié dans le mois précédant la visite de sélection.
    - Patient ayant des antécédents personnels de glaucome et/ou hypertension oculaire dans l’œil étudié (pression intraoculaire (PIO) > 25 mmHg sans médication anti-glaucomateuse ou > 21 mmHg sous bithérapie antiglaucomateuse) et/ou antécédent d’hypertonie cortisonée non contrôlée par une bithérapie antiglaucomateuse.
    - Patient ayant un diabète déséquilibré (HbA1C>8%) ou une HTA déséquilibrée (TAS>160 mmHg et/ou TAD>100mmHg)
    - Maculopathie diabétique œdémateuse
    - Patient ayant déjà reçu dans les 3 mois avant la randomisation de la triamcinolone par voie sous-conjonctivale ou sous-tenonienne, ou dans les 6 mois avant la randomisation l’implant de 700µg de dexaméthasone en intravitréen
    - Antécédents d’infection herpétique oculaire, de choriorétinopathie séreuse centrale
    - Maladie systémique incontrôlée
    - Femme enceinte, ou susceptible de le devenir pendant l’essai ou allaitante
    - Patient participant à un autre essai clinique
    - Patient sous tutelle, curatelle, ou sous mesure de sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    Différence de l’épaisseur maculaire centrale de l’œil soigné, mesurée par OCT Spectral Domain (ou EMC en OCT Time Domain + 50µm) dans les 2 bras entre la sélection et M2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    E.5.2Secondary end point(s)
    - Acuité visuelle (ETDRS)
    - Tyndall protéique antérieur (LAF et LFM si disponible)
    - Tyndall vitréen
    - Epaisseur maculaire centrale de l’œil traité pour la détermination de la durée d’action,
    - Echelle Visuelle Analogique (EVA) + échelle de « vécu » le jour de l’injection (tolérable, désagréable, très désagréable)
    - Evaluation de la tolérance en recueillant tous les EI/EIG des patients randomisés dont HTIO, cataracte, endophtalmie, déséquilibres glycémique et tensionnel.
    - Questionnaire de qualité de vie des patients EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    -l’acuité visuelle (EDTRS) --> 6 mois
    -le Tyndall protéique antérieur (LAF et LFM si disponible) --> 6 mois
    -le Tyndall vitréen --> 6 mois
    -l’épaisseur maculaire centrale de l’œil traité pour la détermination de la durée d’action --> 6 mois
    -Echelle Visuelle Analogique (EVA) + échelle de « vécu » le jour de l’injection (tolérable, désagréable, très désagréable)
    -L’évaluation de la tolérance en recueillant tous les EI/EIG des patients randomisés dont HTIO, cataracte, endophtalmie, déséquilibres glycémique et tensionnel --> 6 mois
    -Questionnaire de qualité de vie des patients EQ-5D --> 6 mois
    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 Yes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned15
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 Yes
    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 state142
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-15
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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
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