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    EudraCT Number:2014-005119-17
    Sponsor's Protocol Code Number:BAY86-5321/17850
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005119-17
    A.3Full title of the trial
    Open-label Phase-4 study to examine the change of vision-related quality of life in subjects with diabetic macular edema (DME) during treatment with intravitreal injections of 2 mg aflibercept according to EU label for the first year of treatment.
    Studio di fase 4 in aperto volto a esaminare il cambiamento della qualità della vita correlata alla vista in soggetti affetti da edema maculare diabetico (DME) durante il trattamento con iniezioni intravitreali di 2 mg di aflibercept secondo la terapia approvata dall’UE per il primo anno di trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of EU-label-treatment with aflibercept on vision-related quality of life and safety in subjects with diabetic macular edema.
    Effetto del trattamento approvato dall’UE aflibercept sulla visione correlata alla qualità della vita e alla sicurezza nei soggetti con edema maculare diabetico
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBAY86-5321/17850
    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 SponsorBayer HealthCare AG
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer HealthCare AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref: 'EU CTR' /Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    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. name Eylea 40mg/ml solution for injection in a vial
    D. of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAflibercept
    D.3.4Pharmaceutical form Solution for injection
    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 codeBAY 86-5321
    D.3.9.3Other descriptive nameVEGF Trap-Eye / AFLIBERCEPT
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    Diabetic macular edema (DME)
    Edema maculare diabetico (DME)
    E.1.1.1Medical condition in easily understood language
    Diabetic macular edema (DME) is a manifestation of Diabetic Retinopathy - damage to the blood vessels of the retina caused by complications of diabetes.
    : Edema maculare diabetico (DME) è una manifestazione della retinopatia diabetica
    Retinopatia - danni ai vasi sanguigni della retina causate da complicanze causate dal diabete
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    E.1.2System Organ Class 10015919 - Eye disorders
    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 quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU label for DME
    Valutare il cambiamento della qualità della vita (NEI VFQ 25) in soggetti affetti da DME durante il primo anno di trattamento con aflibercept secondo la terapia approvata dall’UE
    E.2.2Secondary objectives of the trial
    • To assess further the safety and tolerability of aflibercept in this population
    • To assess the change in the diabetic retinopathy severity score (DRSS) from baseline to Week 52
    • To support patient recruitment for the EMA-requested post-approval efficacy study in DME
    Valutare ulteriormente la sicurezza e la tollerabilità di aflibercept in questa popolazione - Valutare il cambiamento del punteggio della gravità della retinopatia diabetica (DRSS) dalla visita basale alla settimana 52 - Supportare l’arruolamento dei pazienti per lo studio di efficacia nella DME post approvazione in commercio richiesto dall’EMA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults of either sex, ≥ 18 years of age
    2. Willingness and ability to comply with clinic visits and study-related procedures
    3. Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.
    The definition of adequate contraception will be based on the judgment of the investigator and on local requirements.
    Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
    Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously.
    Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
    4. Negative pregnancy test (urine or serum; women of childbearing potential only)
    5. Written informed consent
    6. Type 1 or 2 diabetes mellitus
    7. Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
    8. Decrease in vision determined to be primarily the result of DME in the study eye
    9. BCVA in the study eye of ETDRS letter score 73 to 24
    (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320)
    1. Adulti di entrambi i sessi, ≥ 18 anni di età
    2. Volontà e la capacità di rispettare le visite cliniche e le porcedure dello studio
    3. Donne e gli uomini potenzialmente riprduttivi devono accettare di usare adeguati metodi contraccettivi se sessualmente attivi. Questo vale per il periodo di tempo tra la firma del modulo di consenso informato e 3 mesi dopo l'ultima somministrazione del farmaco in studio. La definizione di un adeguato metodo contraccettivo si baserà sul giudizio dello sperimentatore e sui requisiti locali.
    Metodi accettabili di contraccezione includono, ma non sono limitati a, (i) i preservativi (maschi o femmine), con o senza un agente spermicida; (ii) diaframma o cappuccio cervicale con spermicida; (iii) dispositivo intrauterino; (iv) contraccezione a base di ormoni. I soggetti devono accettare di utilizzare due metodi affidabili e accettabili di contraccezione contemporaneamente. Le donne in postmenopausa devono essere in amenorrea per almeno 12 mesi, per non essere considerati in età fertile
    4. Test di gravidanza negativo (urine siero, solo donne in età fertile solo)
    5. consenso informato scritto
    6. Diabete mellito di tipo 1 o 2
    7. Diagnosi di DME secondario a diabete mellito che coinvolge il centro della macula (definita come l’area del sottocampo centrale nella tomografia ottica a coerenza di fase, OCT) nell’occhio in studio
    8. Riduzione della vista dovuta principalmente a DME nell’occhio in studio
    9. Miglior acuità visiva corretta (BCVA) con punteggio ETDRS da 73 a 24 per le lettere per l’occhio in studio (Questo punteggio corrisponde a un equivalente Snellen di circa 20/40 – 20/230.)
    E.4Principal exclusion criteria
    1. Previous treatment with anti-angiogenic drugs in study eye (e.g. pegaptanib sodium, bevacizumab, ranibizumab) within the last 12 weeks
    2. History of vitreoretinal surgery and/or including scleral buckling in the study eye
    3. Use of long acting steroids, either periocular or intraocular, in the preceding 120 days
    4. Any ocular or periocular infection in the preceding 4 weeks
    5. Active proliferative diabetic retinopathy (PDR), current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
    6. Aphakia in the study eye
    7. Cataract surgery within 90 days
    8. Yttrium-aluminum-garnet capsulotomy in the study eye within 30 days
    9. Any other intraocular surgery within 90 days
    10. Ocular inflammation (including trace or above) or history of uveitis in the study eye
    11. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
    12. Pre-retinal fibrosis involving the macula of the study eye
    13. Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
    14. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
    15. Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
    16. Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
    17. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥ 8 diopters
    18. Administration of systemic anti angiogenic agents within 180 days
    19. Uncontrolled diabetes mellitus in the opinion of the investigator
    20. Uncontrolled blood pressure (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg while subject is sitting confirmed in two separate measurements)
    21. Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept
    22. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
    23. Allergy to fluorescein
    24. Current treatment for a serious systemic infection
    25. History of either cerebral vascular accident and/or myocardial infarction within 180 days
    26. Renal failure requiring dialysis or renal transplant
    27. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications
    28. Significant media opacities, including cataract, in the study eye that interferes with visual acuity, fundus photography or OCT imaging.
    29. Breast-feeding women
    30. Previous assignment to treatment during this study
    31. Concomitant participation in another clinical study with investigational medicinal product(s).
    32. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
    1. precedente trattamento con farmaci antiangiogenici nell'occhio in studio (ad es pegaptanib sodico., bevacizumab, ranibizumab) all'interno delle ultime 12 settimane
    2. Storia di chirurgia vitreoretinica e / o comprendente chrurgia episclerale nell'occhio in studio
    3. Uso di steroidi ad azione prolungata, sia perioculare o intraoculare, nei precedenti 120 giorni
    4. Qualsiasi infezione oculare o perioculare nelle precedenti 4 settimane
    5. Retinopatia diabetica proliferativa (PDR) attiva, con neovascolarizzazione dell'iride, emorragia del vitreo o distacco retinico trazionale nell'occhio in studio
    6. Afachia nell'occhio in studio
    7. Chirurgia della cataratta entro 90 giorni
    8. ittrio-alluminio-granato capsulotomia nell'occhio studio entro 30 giorni
    9. Qualsiasi altro intervento chirurgico intraoculare entro 90 giorni
    10. Infiammazione oculare o storia clinica di uveite nell'occhio in studio
    11. Sindrome da trazione Vitreo-Maculare o membrana epiretinica nell'occhio in studio evidente al microscopio o OCT che può influenzare la visione centrale
    12. Fibrosi pre-retinica che coinvolge la macula dell'occhio in studio
    13. Danni strutturali al centro della macula nell'occhio in studio suscettibile di precludere un miglioramento BCVA a seguito della risoluzione dell’edema maculare compresa l’ atrofia dell'epitelio pigmentato retinico, la fibrosi sottoretinica o cicatrice, significativa ischemia maculare o organizzati essudati duri
    14. Passata chirurgia filtrante per glaucoma o che potrebbe rendersi necessaria in futuro sull'occhio in studio
    15. Pressione intraoculare (IOP) ≥ 25 mmHg nell'occhio in studio
    16. Malattia concomitante nell'occhio in studio, diverso da DME, che potrebbe compromettere VA, che richiede un intervento medico o chirurgico, durante il periodo dello studio, o possa confondere l'interpretazione dei risultati (inclusi occlusione vascolare retinica, distacco di retina, foro maculare, o neovascolarizzazione coroideale di qualsiasi natura)
    17. Miopia di un equivalente sferico prima di un qualsiasi intervento di chirurgia refrattiva o di cataratta ≥ 8 diottrie
    18. Somministrazione di farmaci antiangiogenici sistemici entro 180 giorni
    19. Diabete mellito non controllato a giudizio dello sperimentatore
    20. Pressione arteriosa non controllata (definita come pressione arteriosa sistolica> 160 mmHg o diastolica > 95 mmHg mentre il soggetto è seduto e confermata con misurazioni distinte)
    21. Presenza di eventuali controindicazioni indicate dalla Commissione UE / approvato localmente per aflibercept
    22. Diagnosi di Blefarite infettiva , cheratite, sclerite, o congiuntivite in entrambi gli occhi
    23. Allergia alla fluoresceina
    24. Trattamento in corso per una grave infezione sistemica
    25. Storia clinica di un evento vascolare cerebrale e / o infarto miocardico entro 180 giorni
    26. Insufficenza renale che richede dialisi o trapianto renale
    27. Storia clinica di altre malattie, disfunzioni metaboliche, valutazioni dall’esame fisico, o valore di laboratorio che da ragionevole sospetto di una malattia o condizione per cui è controindicato l'uso di un farmaco sperimentale, che potrebbe influenzare l'interpretazione dei risultati dello studio, o rende il soggetto a alto rischio di complicanzioni con il trattamento
    28. Opacità significativa, tra cui la cataratta, nell'occhio in studio che interferisce con l’acuità visiva, fotografia del fondo oculare o immagini OCT.
    29. Donne che allattano
    30. Precedente assegnazione a trattamento nel corso di questo studio
    31. Partecipazione concomitante ad un altro studio clinico con un prodotto sperimentale.
    32. Stretta relazione con il centro sperimentale; es un parente stretto del ricercatore, persona dipendente (ad esempio, impiegato o studente del centro sperimentale)
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Week 52 in the NEI VFQ 25 total score.
    Cambiamento del punteggio totale del questionario EI VFQ 25 alla settimana 52 rispetto alla visita basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    52 Settimane
    E.5.2Secondary end point(s)
    Efficacy assessments:
    The change from baseline to Week 52 in the NEI VFQ 25 near activities subscale.
    The change from baseline to Week 52 in the NEI VFQ 25 distant activities subscale.
    The change from baseline to Week 52 in BCVA (ETDRS letter score).
    The change from baseline to Week 52 in CRT measured by OCT.
    Safety assessments:
    Intraocular pressure and adverse events every 4 weeks.
    Vital signs at baseline and at week 52.
    Valutazioni di efficacia:
    Cambiamento dal basale alla Settimana 52 nella sottoscala NEI VFQ-25 attività da vicino
    Cambiamento dal basale alla Settimana 52 nella sottoscala NEI VFQ-25 attività da lontano.
    Cambiamento dal basale alla Settimana 52 in BCVA (ETDRS punteggio basato sul numero di lettere).
    Cambiamento dal basale alla Settimana 52 in CRT misurato da OCT
    Valutazione della sicurezza: La pressione intraoculare e gli eventi avversi ogni 4 settimane.
    I segni vitali al basale e alla settimana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (vital signs), every 4 weeks (intraocular pressure) and Week 52 (efficacy assessments and vital signs).
    Baseline (segni vitali), ogni 4 settimane (pressione intraoculare) e la settimana 52 (valutazioni di efficacia e di segni vitali).
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    United Kingdom
    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
    The end of the study as a whole will be reached as soon as the last visit of the last subject (LVLS) has been reached in all centres in all participating countries (EU and non-EU).
    La fine dello studio nel suo complesso sarà raggiunta non appena l'ultima visita
    dell'ultimo soggetto (LPLV) è stata raggiunta in tutti i centri di tutti paesi partecipanti (UE e non UE)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 436
    F.4.2.2In the whole clinical trial 490
    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)
    After the end of this study, subjects will not be restricted with regard to pursuing available treatments for DME.
    After completion of this study, subjects may subsequently be enrolled into the sponsor’s post-approval efficacy study further investigating the efficacy of aflibercept in DME patients.
    Dopo la fine di questo studio, i soggetti non saranno obbligati a perseguire con trattamenti disponibili per DME.
    Dopo il completamento di questo studio, i soggetti possono essere successivamente arruolati nello studio post- approval sull'efficacia che indaga ulteriormente l'efficacia di aflibercept in pazienti con DME.
    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 Decision2015-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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