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    Summary
    EudraCT Number:2014-003193-17
    Sponsor's Protocol Code Number:BAY86-5321/17514
    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:2021-02-09
    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 number2014-003193-17
    A.3Full title of the trial
    A multi center, single arm, interventional Phase 4 study to evaluate a Treat and Extend regimen of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion
    Studio multicentrico a braccio singolo interventistico di Fase 4 per valutare un regime “treat and extend” di somministrazione intravitreale di aflibercept per il trattamento di edema maculare secondario a occlusione della vena centrale della retina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVO
    Valutazione di un regime "treat and extend" di soministrazione intravitreale di aflibercept per l'edema maculare secondario a CRVO
    A.3.2Name or abbreviated title of the trial where available
    CENTERA
    CENTERA
    A.4.1Sponsor's protocol code numberBAY86-5321/17514
    A.5.4Other Identifiers
    Name:BAY86-5321/17514Number:Finale
    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 AG
    B.1.3.4CountryGermany
    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.4.2CountryGermany
    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 pointClinical Trials Contact, CTP EU CTR
    B.5.3 Address:
    B.5.3.1Street AddressBerlin Pharma AG
    B.5.3.2Town/ cityBerlino
    B.5.3.3Post codeD-13342
    B.5.3.4CountryGermany
    B.5.4Telephone number000000000000
    B.5.5Fax number00000000000
    B.5.6E-mailclinical-trial-cointact@bayerhealthcare.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 Eylea
    D.2.1.1.2Name 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.3.2Product code [Aflibercept]
    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 codeBAY86-5321
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Macular edema secondary to CRVO
    Edema maculare secondario a CRVO
    E.1.1.1Medical condition in easily understood language
    Retinal venous occlusive disease is an important cause of vision loss, particularly in patients with associated chronic macular edema
    la patologia dell'occlusione della vena retinica è un'importante causa di perdita della vista, particolarmente per I pazienti con un associate edema maculare cronico
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 determine the efficacy and durability (treatment interval) of 2 mg IVT aflibercept in a T&E regimen over a treatment period of 76 weeks using protocol defined visual and anatomic criteria in subjects with macular edema secondary to CRVO
    Determinare l’efficacia e la durabilità (intervallo di trattamento) di 2 mg di aflibercept somministrato per via intravitreale (IVT) in un regime di trattamento flessibile, il cosiddetto regime "Treat and Extend" (T&E) per un periodo di trattamento di 76 settimane secondo criteri visivi e anatomici definiti nel protocollo in soggetti con edema maculare secondario a occlusione della vena centrale della retina [Central Retinal Vein Occlusion, CRVO.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of IVT aflibercept as measured by visual acuity and anatomic outcomes using spectral domain optical coherence tomography (SD OCT), and perfusion status using FA/fundus photography (FP)
    - to assess T&E applied posology of IVT aflibercept (number of injections, length of injection interval)
    - Valutare l’efficacia di aflibercept IVT misurandola in base agli esiti di acuità visiva e anatomici mediante tomografia a coerenza ottica nel dominio spettrale [Spectral Domain Optical Coherence Tomography, SD-OCT] e in base allo stato di perfusione mediante angiografia con fluoresceina [fluorescein angiography, FA]/fotografia del fondo [fundus photography, FP].
    - Valutare la posologia impiegata in regime T&E di aflibercept IVT (numero di iniezioni, durata dell’intervallo fra due iniezioni).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of = 3 months since onset of macular edema at their scheduled baseline visit). - Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T&E regimen after initial dosing.
    - Treatment-naïve subjects for macular edema secondary to CRVO.
    - Men and women = 18 years of age.
    - Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye
    -Edema maculare con coinvolgimento della parte centrale secondario a CRVO da non più di 3 mesi prima dell’inizio del trattamento con il farmaco in studio.
    -Soggetti adulti con diagnosi di edema maculare secondario a CRVO che sono programmati per essere trattati con IVT aflibercept come da prassi di trattamento di routine del ricercatore con l'intento di utilizzare un regime di T&E dopo la somministrazione iniziale.
    -Soggetti naïve al trattamento per edema maculare secondario a CRVO
    -Uomini e donne di età = 18 anni
    -Documentata BCVA con un punteggio in lettere ETDRS tra 73 e 24 lettere (equivalente di Snellen tra 20/40 e 20/320 nell'occhio in studio).
    E.4Principal exclusion criteria
    - Previous PRP or macular laser photocoagulation in the study eye.
    - Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
    - Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
    - Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
    - Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
    - Any history of allergy to povidone iodine.
    - Known serious allergy to the fluorescein sodium for injection in angiography.
    - Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.
    - Precedente intervento di fotocoagulazione nell’occhio in studio
    - Qualsiasi trattamento oculrae precedente o concomitante (ad esempio, la terapia anti-VEGF, corticosteroidi) nell'occhio di studio per l'edema maculare secondario a RVO, ad eccezione di integratori alimentari o vitamine prima dell' inclusione nello studio. Il trattamento anti-VEGF intraoculare è consentito per il trattamento di patologie del fellow.eye, ad eccezione di quei trattamenti che sono espressamente esclusi.
    - Precedente terapia sistemica con farmaci anti VEGF o corticosteroidi nei 3 mesi precedenti dalla prima dose di farmaco.
    - Precedente uso di corticosteroidi intraoculari nell'occhio in studio in qualsiasi momento o uso di corticosteroidi perioculari nell'occhio in studio entro 12 mesi prima del giorno 1.
    - Presenza di una qualsiasi infezione intraoculare, extraoculare o perioculare nelle 4 settimane precedenti la visita di screening in entrambi gli occhi.
    - Qualsiasi storia di allergia allo iodio povidone.
    - Grave allergia nota al sodio fluoresceina per l'iniezione in angiografia.
    - Presenza di una qualsiasi controindicazione indicata nel foglio illustrativo approvato di aflibercept: ipersensibilità alla sostanza attiva aplibercept per IVT o ad una qualsiasi altro eccipiente;
    E.5 End points
    E.5.1Primary end point(s)
    1) The proportion of subjects who gain = 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy score chart.
    2) The proportion of subjects with a mean treatment interval between injections of = 8 weeks
    1) Proporzione di soggetti che guadagnano = 15 lettere di BCVA nella tavola ETDRS rispetto al basale alla Settimana 76.
    2) Proporzione di soggetti con un intervallo di trattamento medio fra le iniezioni di = 8 settimane tra l’ultima visita effettiva della fase di avvio e la Settimana 76.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Compared with baseline at Week 76
    2) From the last actual visit of the initiation phase to Week 76
    1) Paragone tra basale e settimana 76
    2) Dall'ultima attuale vista della fase di iniziazione alla settimana 76
    E.5.2Secondary end point(s)
    3) The number of injections; The mean treatment interval between injections; 5) The proportion of subjects who gain = 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart ; 6) The change in retinal perfusion (FA/FP) status; 7) The proportion of subjects with absence of fluid ; 8) Number and severity of ocular safety events detected by tonometry, indirect ophthalmoscopy, slit lamp biomicroscopy, and gonioscopy; 1) The change in best corrected visual acuity as measured by the early treatment diabetic retinopathy letter score
    2) The change in central retinal thickness; 2) Variazione dello spessore retinico centrale [Central Retinal Thickness, CRT] dal basale alle Settimane 24, 52 e 76; 3) Numero di iniezioni.; 4) Intervallo di trattamento medio fra le iniezioni; 5) Proporzione di soggetti che guadagnano = 15 lettere di BCVA nella tavola ETDRS.; 6) Variazione nello stato di perfusione retinica (FA/FP).; 7) Percentuale di soggetti che presentano assenza di fluido; 8) numero e severità di eventi di safety oculare trovati mediante tonometria, oftalmoscopia indiretta, biomicroscopia con lampada a fessura e gonioscopia ; 1) Proporzione di soggetti che guadagnano = 15 lettere di BCVA nella tavola ETDRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    2) From baseline to Weeks 24, 52, and 76 ; 3) From baseline to Week 76; 4) From baseline to Week 76; 5) Compared with baseline at Weeks 24 and 52 ; 6) From baseline to Weeks 24, 52 and 76; 7) At Weeks 24, 52, and 76; 8) 30 days after week 76; 1) From baseline to Weeks 24, 52, and 76
    2) dal basale alle Settimane 24, 52 e 76.; 3) dal basale alla Settimana 76; 4) dal basale alla Settimana 76. ; 5) rispetto al basale alle Settimane 24 e 52. ; 6) dallo screening/basale alle Settimane 24, 52 e 76; 7) Settimane 24, 52 e 76; 8) 30 giorni dopo la settimana 76; 1) dal basale alle Settimane 24, 52 e 76.
    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) 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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Denmark
    France
    Germany
    Italy
    Spain
    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
    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 months9
    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 months9
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 160
    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
    nessuno
    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 Decision2016-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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