Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-003193-14
    Sponsor's Protocol Code Number:DIAMOND
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-25
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-003193-14
    A.3Full title of the trial
    Disease-modification under treatment with aflibercept in advanced diabetic retinopathy - A pilot study
    Therapie mit Aflibercept bei proliferativer diabetischer Retinopathie - eine prospektive, klinische Pilot-Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Disease-modification of advanced retinal disease secondary to diabetes mellitus
    Auswirkungen einer Injektions-Therapie auf fortgeschrittene Netzhautveränderungen bei Diabetikern.
    A.3.2Name or abbreviated title of the trial where available
    DIAMOND
    A.4.1Sponsor's protocol code numberDIAMOND
    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 SponsorDepartment of Ophthalmology, MUW
    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 supportMedical University Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment if Iohthalmology, MUW
    B.5.2Functional name of contact pointClinical Trial Center Vienna
    B.5.3 Address:
    B.5.3.1Street AddressWaehringerguertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040048470
    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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNAFLIBERCEPT
    D.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeBAY86-5321
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product Yes
    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
    proliferative diabetic retinopathy
    Proliferative diabetische Retinopathie
    E.1.1.1Medical condition in easily understood language
    advanced retinal changes in diabetic patients
    Fortgeschrittene Netzhautveränderungen infolge von Zuckerkrankheit
    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
    To evaluate the change in ETDRS diabetic retinopathy severity score from baseline to m12 and to m36
    Erfassen von Veränderungen des Schweregrads der diabetischen Retinopathie anhand der ETDRS Skala von Baseline zu Monat 12 und Monat 36.
    E.2.2Secondary objectives of the trial
    The secondary objectives also cover parameters related to vascular integrity and its improvement under repeated aflibercept treatment
    Erfassen von Veränderungen an den Netzhautgefäßen durch die Behandlung mit Aflibercept.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Active proliferative diabetic retinopathy (ETDRS severity 61 or higher)
    Diagnosis of type 1 or type 2 diabetes
    ≥ 18 years of age
    Written informed consent to participate in the study
    Aktive proliferative diabetische Retinopathie (eTDRS Schweregrad 61 oder höher)
    diagnostizierter Typ 1 oder Typ 2 Diabetes
    Alter ≥ 18 Jahre
    Unterschriebene Patienteninformation
    E.4Principal exclusion criteria
    Intravitreal injection of any Anti-VEGF therapy in the study eye within 6 months prior to study inclusion
    Intraocular surgery, laser therapy (argon or YAG) in the study eye within 3 months prior to study inclusion
    Uncontrolled glaucoma
    Media opacities in the study eye
    Cardiovascular event within the past 6 months
    Allergy to study drug or to fluorescein
    retinal traction/detachment caused by proliferative membrane
    Active intraocular inflammation (grade trace or above) in the study eye, like infectious conjunctivitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis
    Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
    Individual is expecting to move out of the area of the clinical center during the study period of 36 months..
    pregnant or breast-feeding women
    Vorbehandlung mit einem anti-VEGF Medikemant innerhalb von 6 Monaten vor Studieninklusion
    Augenoperation oder Laserbehandlung (Argon oder YAG) im Studienauge innerhalb von 3 Monaten vor Studieninklusion
    Unkontrolliertes Glaukom
    Medientrübung
    Kardiovaskulärer Zwischenfall (Myocardinfarkt, Angina pectoris, Schlaganfall) innerhalb von 6 Monaten vor Studieninklusion
    Allergie auf das Studienmedikament oder auf Fluoreszin
    Netzhauttraktion oder -abhebung durch eine proliferative Membran
    Aktive Augenentzündung
    Systemische anti-VEGF oder pro-VEGF Behandlung innerhalb von 4 Monaten vor Studieninklusion
    Geplanter Auslandsaufenthlet oder Umzug, der ein Einhalten der Studienvisiten unmöglich macht
    Schwangere oder stillende Frauen
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of study eyes with DRSS improvements of 1 step or more
    The proportion of study eyes with DRSS improvement of 2 steps or more
    The proportion of study eyes with DRSS improvement of 3 steps or more
    The mean change (standard deviation) in DRSS
    Anteil der Patienten in % mit Verbesserung im ETDRS DRSS um 1 Schritt oder mehr
    Anteil der Patienten in % mit Verbesserung im ETDRS DRSS um 2 Schritte oder mehr
    Anteil der Patienten in % mit Verbesserung im ETDRS DRSS um 3 Schritte oder mehr
    Veränderung im ETDRS DRSS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12 and 36
    Monat 12 und Monat 36
    E.5.2Secondary end point(s)
    Proportion of study eyes exhibiting a specific feature (such as microaneurysms, vessel loops, capillary dropout, intraretinal microvascular abnormalities, venous beading, and potentially yet undescribed phenomena)
    Proportion of study eyes with regression of proliferative membrane
    Mean change in peripheral visual field
    Mean change in best corrected visual acuity
    Mean change in capillary vessel density
    Mean change in capillary fractal index
    Mean change in area of non-perfused capillaries
    Mean change in oxigen saturation in venules and areriols
    Characterization of cytokine levels in the aqueous humor and change following anti-VEGF treatment
    Anteil der Augen, die pathognomonische Veränderungen wie Mikroaneurysmen, Kapillarnetzausfälle, intraretinale Gefäßveränderungen, venöse Kalliberschwankungen oder bisher noch nicht beschriebene Veränderungen zeigen
    Anteil der Augen mit regression der Proliferativen Membran
    Änderung im Gesichtsfeld
    Visusveränderung
    Veränderung der Kapillarnetzdichte
    Veränderung der Kapillarverzweigung
    Veränderung des nicht perfundierten Kapillarnetzes
    Bestimmung der Cytokin-Konzentration im Kammerwasser vor und während der anti-VEGF Therapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    monthly or annually, dependent on the imaging method applied
    Monatlich bzw jährlicher Verlauf
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLP
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state15
    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 Decision2017-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-09-18
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 19:00:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA