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    Summary
    EudraCT Number:2010-023900-29
    Sponsor's Protocol Code Number:MAF-AGN-OPH-RET-004
    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:2012-02-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-023900-29
    A.3Full title of the trial
    A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare
    the Efficacy and Safety of Ozurdex Versus Lucentis in Patients with
    Branch Retinal Vein Occlusion
    Studio multicentrico, randomizzato, a gruppi paralleli, della durata di 12 mesi, condotto per confrontare l'efficacia e la sicurezza di Ozurdex versus Lucentis in pazienti affetti da occlusione venosa retinica di branca
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Ozurdex versus Lucentis in the treatment of Branch
    Retinal Vein Occlusion
    Confrontare Ozurdex versus Lucentis nel trattamento da occlusione venosa retinica di branca
    A.4.1Sponsor's protocol code numberMAF-AGN-OPH-RET-004
    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 SponsorALLERGAN PHARMACEUTICALS IRELAND
    B.1.3.4CountryIreland
    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 supportAllergan Pharmaceuticals Ireland
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 494444
    B.5.5Fax number+44 1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    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 Ozurdex
    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.3.4Pharmaceutical 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.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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.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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical 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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Macula oedema secondary to branch retinal vein occlusion
    Edema maculare secondario ad occlusione venosa retinica di branca
    E.1.1.1Medical condition in easily understood language
    Blockage of veins in the eye that leads to build up of fluid causing swelling in the the macula.This may lead to damage to the macula which affects your central vision
    Blocco delle vene nell'occhio che porta alla formazione di liquidi che causano gonfiore nella macula. Questo causa danni alla macula che colpisce la visione centrale
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10025415
    E.1.2Term Macular oedema
    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 compare the efficacy and safety of Ozurdex vs. Lucentis in subjects with BRVO
    Confrontare l’efficacia e la sicurezza di Ozurdex vs. Lucentis in soggetti affetti da BRVO
    E.2.2Secondary objectives of the trial
    None
    Nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, ≥ 18 years of age 2. Written informed consent has been obtained 3. Written Data Protection Consent (European sites only) has been obtained 4. Study eye must have clear ocular media and adequate pupil dilation to permit good quality photographic imaging 5. ME secondary to BRVO in the study eye with all of the following characteristics: a) involving the centre of the macula (fovea) b) central retina subfield thickness ≥ 320 μm as assessed with Spectralis optical coherence tomography (OCT) or ≥ 300 μm as assessed with Cirrus OCT c) less than 90 days from onset of BRVO symptoms to screening visit d) visual acuity (VA) decrease attributable to retinal oedema Note: Characteristics a and b will be confirmed by a CRC 6. Absence of severe macular ischemia (defined as an area of nonperfusion > 4 disc areas [DA] which involve the foveal avascular zone), as confirmed by a CRC 7. BCVA score of ≥ 20 to ≤ 70 letters (20/40 to 20/400 Snellen equivalent) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol at both the screening visit and day 1 visit. 8. Female subjects of childbearing potential must have a negative urine pregnancy test at the screening (day -14) visit
    1.Uomini o donne di eta' ≥ 18 anni 2.Consenso informato scritto 3.Consenso scritto alla protezione dei dati personali 4.Occhio con la media oculare chiara e adeguata dilatazione della pupilla per permettere una buona qualita' delle immagini fotografiche 5.EM secondaria a BRVO nell`occhio in studio con tutte le seguenti caratteristiche: a) coinvolgimento del centro della macula (fovea) b) Spessore medio retinico centrale ≥ 320 μm rilevato con Spectralis OCT (Heidelberg) o ≥ 300 μm rilevato con Cirrus OCT (Carl Zeiss).c) meno di 90 giorni dalla comparsa dei sintomi BRVO alla visita di screening d) la diminuzione dell’acuita' visiva (VA) attribuibile ad edema retinico Nota: le caratteristiche a e b saranno confermata da un CRC 6.Assenza di grave ischemia maculare (definita come una zona di non perfusione &gt; 4 aree del disco che coinvolgono la zona foveale avascolare), come confermato da un CRC 7.Punteggio BCVA da ≥ 20 a ≤ 70 lettere (20/40 a 20/400 equivalente Snellen) utilizzando lo studio Trattamento precoce per la retinopatia diabetica (ETDRS) protocollo sulla acuita' visiva sia alla visita di screening che alla visita giorno 1. 8.Soggetti di sesso femminile in eta' fertile devono avere un test di gravidanza sulle urine alla visita di screening (giorno -14)
    E.4Principal exclusion criteria
    1.History of a medical condition that, in the opinion of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of study medication. 2.Ocular hypertension unless controlled with monotherapy. 3.Pregnant or nursing (lactating) women, 4.Pre-menopausal women of child-bearing potential not using adequate Contraception. 5.Participation in an investigational drug or device study within 30 days of the screening visit. 6.Any current or history of ocular disease in the study eye other than RVO that, in the opinion the investigator, may confound assessment of the macula or affect central vision, such as exudative age-related macular degeneration, geographic atrophy, diabetic retinopathy, uveitis, streaks, histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole, or significant cataract 7.History of cataract surgery in either eye within the past 3 months prior to the screening visit 8.History or evidence of serious ocular trauma or intraocular surgery (such as laser-assisted in situ keratomileusis, keratoplasty, vitrectomy) in the study eye within the past 6 months prior to the screening visit 9.History of severe or serious hypersensitivity to any components of the test article or fluorescein dye. 10.> 10-Letter improvement in BCVA between the screening visit and day 1 11.Brisk afferent pupillary defect (ie, obvious and unequivocal) 12.Aphakia in the study eye or violation of the posterior capsule in the study eye, unless it occurred as a result of a yttrium-aluminum-garnet laser posterior capsulotomy in association with prior, posterior intraocular lens implantation 13.Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in adnexa of either eye 14.History of radial optic neurotomy or sheathotomy 15.Laser photocoagulation for ME in the study eye within 3 months prior to the screening visit 16.Anticipated need for ocular surgery or ophthalmic laser treatment in the study eye during the 12-month study period 17.Prior anti-VEGF treatment in study or fellow eye within 3 months of screening or systemic anti-VEGF treatment within 6 months of the screening visit 18.Use of intraocular, intravitreal, or peri-ocular steroids in the study eye within 3 months of the screening visit 19.Use of systemic steroids (eg, oral, intravenous, intra-articular, epidural, intrabursal) within 1 month of screening or anticipated use at any time during the study. Inhaled and intranasal steroids are allowed. 20.IOP > 22 mm Hg at screening or day 1 visit in either eye.
    Storia di una condizione clinioca che, a giudizio dello sperimentatore, precluderebbe in le visite dellostudio, il completamento dello studio, o la somministrazione sicura del farmaco in studio. Ipertensione oculare controllata meno con monoterapia. 3.Donne in gravidanza o in allattamento 4.Donne in eta' fertile in pre-menopausa che non usano contraccettivi adeguati. 5.Participatione a un farmaco sperimentale o dispositivo medico 30 giorni prima la visita di screening. 6. Qualsiasi storia clinica in corso o passata di malattia oculare negli occhio RVO diverso da quello che, a giudizio del ricercatore, poptrebbe confondere la valutazione della macula o influire la visione centrale, come essudativa legata all`eta' della degenerazione maculare, atrofia geografica, retinopatia diabetica, uveite, striature, istoplasmosi, miopia patologica, distacco di retina, membrana epiretiniche, foro maculare, o significativa cataratta 7.Intervento chirurgico di cataratta in entrambi gli occhi negli ultimi 3 mesi prima della visita di screening 8.Storia clinica o evidenza di traumi oculari gravi o interventi chirurgici intraoculare (come il laser-assistita in situ cheratoplastica, vitrectomia) nell`occhio in studio negli ultimi 6 mesi precedenti la visita di screening 9.Storia di ipersensibilita' grave o seria ai principi del farmaco in studio o al colorante fluoresceina. 10.&gt; 10-Lettera miglioramento BCVA tra la visita di screening e giorno 1 11. Difetto alla pupillare (ad esempio, evidente e inequivocabile) 12. Afachia nell`occhio in studio o violazione della capsula posteriore nell`occhio in studio, a meno che non sia verificato come risultato di capsulotomia posteriore in associazione con la prima, impianto di lente intraoculare posteriore 13. Qualsiasi infezione oculari attive (batteriche, virali,parassitarie o fungine) 14. Storia di neurotomia ottica radiale o di guainotomia. 15.Fotocoagulazione per ME nell`occhio in studio entro 3 mesi prima della visita di screening 16.Anticipata la necessita' di un intervento oculare chirurgico o trattamento laser oftalmico nell`occhio in studio durante il periodo di 12 mesi dello studio 17.Anti-VEGF trattamento entro 3 mesi dallo screening o o trattamento sistemico anti VEGF trattamento entro 6 mesi dalla visita di screening 18.Uso di intraoculare, intravitreali, o peri-oculare steroidi nell`occhio in studio entro 3 mesi dalla visita di screening 19. Uso di steroidi per via sistemica (ad esempio, orale, endovenosa, intra-articolare, epidurale) entro 1 mese dallo screening o in qualsiasi momento durante lo studio. Sono ammessi steroidi per via inalatoria e intranasale. 20.IOP&gt; 22 mm Hg allo screening o al giorno 1 in ciascun occhio
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is mean change in BCVA at month 12.
    Variabile primaria di efficacia e' la variazione media in BCVA al 12 mese
    E.5.1.1Timepoint(s) of evaluation of this end point
    BCVA assessment at screening, baseline, day 7 and at each monthly visit
    Valutazione BCVA allo screening, al basale, al giorno 7 e ad ogni visita mensile
    E.5.2Secondary end point(s)
    1.Mean change in the central retina subfield thickness between baseline and month 6, and between baseline and month 12 2. Proportion of subjects with ≥ 15-letter improvement in BCVA between baseline and month 12 3. Proportion of subjects with ≥ 15-letter decrease in BCVA between baseline and month 12 4. Change from baseline in vision-dependent subfields of the VFQ-25 questionnaire including near vision, far vision, and vision-dependent activity at month 3, month 6, and month 12. 5. Proportion of subjects in each treatment arm not completing the month 12 visit due to treatment failure. Treatment failure is defined as a subject withdrawn by the investigator prior to the final visit because of a lack of efficacy.
    Variazione media nello spessore medio retinico centrale tra il basale e il mese 6, e tra il basale e il mese 12 Percentuale di soggetti con miglioramento ≥ di 15-lettera in BCVA tra il basale e il mese 12 Percentuale di soggetti con ≥ diminuzione di 15 lettere di BCVA tra il basale e il mese 12 Cambiamento dal basale nei sottocampi visione dipendente del questionario VFQ 25 compresa la visione da vicino, visione lontana, la visione e l`attivita'-dipendente al mese 3, al mese 6 e al mese 12 Percentuale di soggetti che hanno interrotto il trattamento per scarsa efficacia in entrambi i bracci prima del 12 mese. Per fallimento del trattamento si intende un soggetto ritirato dallo sperimentatore prima della visita finale a causa di una mancanza di efficacia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. OCT assessments that will be used in evaluation of timepoint will be done at baseline, month 6 and month 12. 2. and 3. BCVA assessments that will be used in evaluation of timepoints will be done at baseline and month 12. 4. VFQ-25 questionnaire completed at baseline, month 3, month 6, and month 12.
    1. Valutazioni OCT che saranno utiliizzati per la valutazione dei timepoint che saranno eseguiti alla visita basale, mese 6 e mese 12 2. e 3. Valutazioni BCVA che veranno utilizzate per la valutazione dei tempi che saranno eseguiti alla visita basale e mese 12. 4. VFQ-25 questionario compilato al basale, mese 3, mese 6 e mese 12
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Israel
    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
    LVLS
    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 months0
    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 months0
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 400
    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)
    Subjects will return to their standard of care treatment as determined by their physician after completion of the trial.
    Soggetti ritorneranno al cure standard come stabilito dal proprio medico dopo la conclusione dello studio clinico.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation National Institute for Health Research comprehensive clinical research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-04
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