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    Summary
    EudraCT Number:2016-003232-21
    Sponsor's Protocol Code Number:CLOUD
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-003232-21
    A.3Full title of the trial
    EffiCacy and safety of topical ketoroLac trOmethamine and sUbtenon triamcinolone acetonideand a “watch-and-wait” strategy for acute pseudophakic macular eDema: a randomized phase-3 trial
    Beurteilung der Wirksamkeit und Sicherheit von topischem Ketorolac-Trometamol, sub-Tenon Triamcinolonacetonid oder Observanz zur Behandlung des akuten pseudophaken Makulaödems: eine randomisierte Phase-3 Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy and safety of "Acular" eyedrops or a singular "Volon A 40" injection compared to a "no treatment" group in patients with macular edema (swelling of the retina due to accumulation of fluid) following cataract (clouding of the eye lens) surgery.
    Die Wirksamkeit und Sicherheit von "Acular" Augentropfen, oder einer einmaligen "Volon A 40" Injektion bei Patienten mit Makulaödem (Schwellung der Netzhaut infolge einer Flüssigkeitsansammlung) nach einer Grauen Star Operation, verglichen mit einer Gruppe ohne Behandlung.
    A.3.2Name or abbreviated title of the trial where available
    CLOUD
    CLOUD
    A.4.1Sponsor's protocol code numberCLOUD
    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 SponsorMedizinische Universität Graz, Univers. Augenklinik
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz
    B.5.2Functional name of contact pointUnivers. Augenklinik
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 4
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.6E-maillaura.pertl@medunigraz.at
    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 Acular 0,5% Augentropfen
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAcular 0,5% Augentropfen
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETOROLAC TROMETAMOL
    D.3.9.1CAS number 74103-07-4
    D.3.9.4EV Substance CodeSUB02835MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Volon A 40 Kristallsuspension Ampulle
    D.2.1.1.2Name of the Marketing Authorisation holderDermapharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameVolon A 40 Kristallsuspension Ampulle
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    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 CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    Pseudophakic macular edema
    Pseudophakes Makulaödem
    E.1.1.1Medical condition in easily understood language
    Swelling of the retina caused by an accumulation of fluid following cataract (clouding of the eye lens) surgery
    Durch eine Flüssigkeitsansammlung hervorgerufene Schwellung der Netzhaut in Folge einer Katarakt (Linsentrübung: Grauer Star) Operation.
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    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
    To assess the efficacy of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in subjects with pseudophakic cystoid macular edema, compared to a “watch-and-wait” strategy.
    Evaluierung der Wirksamkeit von Ketorolac-Trometamol Augentropfen oder einer Sub-Tenon-Injektion von Triamcinolonacetonid bei der Behandlung eines zystoiden Makulaödems, verglichen mit einer Observanzgruppe.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in this population, compared to a "watch and wait" strategy
    Evaluierung der Sicherheit von Ketorolac Trometamol Augentropfen bzw. einer Injektion von Triamcinolonacetonid bei dieser Patientengruppe, verglichen mit einer Observanzgruppe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥18 years of age
    -Pseudophakia in the study eye
    -No history of previous treatment of PME
    -Signed written informed consent
    -Cataract surgery ≤4 months in study eye
    -BCVA ≥20/125; BVCA ≤20/32
    -Presence of PME determined by fundus examination
    -Presence of central macular edema determined by OCT
    -No sign of significant diabetic retinopathy and/or maculopathy
    - Alter ≥18
    - Pseudophakie am Studienauge
    - Keine vorangegangene Behandlung eines Makulaödems
    - Unterschriebene Einwilligungserklärung
    - Kataraktoperation längstens vier Monate vor Einschluss
    - BCVA ≥20/125; BVCA ≤20/32
    - Durch Fundusuntersuchung bzw. OCT Messung nachgewiesenes Makulaödem
    - Keine signifikanten Makulopathien/diabetische Retinopathie
    E.4Principal exclusion criteria
    -Pregnancy /Breast-feeding
    -Systemic treatment with corticosteroids in the preceding 14 days
    -Systemic treatment with NSAIDs in the preceding 14 days
    -Presence of any contradictions indicated in the summary of product characteristics for the use of topical ketorolac tromethamine 0.5% and subtenon triamcinolone acetonide injection
    -Active choroidal neovascularization
    -Retinal detachment
    -Vitreoretinal surgery in the preceding year
    -Myopia ≥8 diopters
    -Uncontrolled glaucoma
    -Schwangerschaft/Stillen
    -Systemische Kortikosteroid Behandlung innerhalb der vorangegangenen 14 Tage
    - Sytemische Behandlung mit NSAIDs innerhalb der vorangegangenen 14 Tage
    -Vorliegen von Kontraindikationen für die Behandlung mit der Studienmedikation
    - Choroidale Neovaskularisationen
    -Ablatio Retinae
    -Vitreoretinale Operation im vorangegangenen Jahr
    - Myopie ≥8 Dioptrien
    - unkontrolliertes Glaukom
    E.5 End points
    E.5.1Primary end point(s)
    Change in central retinal thickness measured by OCT from baseline to week 6
    Mit OCT gemessene zentrale Netzhautdicke 6 Wochen nach Baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks after baseline
    6 Wochen nach Baseline
    E.5.2Secondary end point(s)
    -Change in BCVA (Best Corrected Visual Acuity) in ETDRS letters from baseline to week 3 and week 6
    -Change in central retinal thickness measured by OCT from baseline to week 3
    -Complete resolution (binary) of macular edema measured by OCT at week 3 and week 6
    -Change in ocular pain assessment from baseline to week 3 and week 6
    -Change in dry eye questionnaire from baseline to week 3 and week 6
    -Veränderung der BCVA 3 und 6 Wochen nach Baseline
    -Veränderung der mit OCT gemessenen zentralen Netzhautdicke 3 Wochen nach Baseline
    -Resolution des Makulaödems nach 3 bzw. 6 Wochen
    -Schmerzerhebung 3 und 6 Wochen nach Baseline
    -Fragebogen Trockenes Auge 3 und 6 Wochen nach Baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three and six weeks after baseline
    Drei und 6 Wochen nach Baseline
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Observanzgruppe ohne Behandlung
    Watch and wait strategy: no treatment
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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
    Letzter Besuch des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 224
    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 Yes
    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 state249
    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)
    None
    Keine
    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 Decision2017-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-06
    P. End of Trial
    P.End of Trial StatusOngoing
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