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    Summary
    EudraCT Number:2013-003333-15
    Sponsor's Protocol Code Number:CRFB002AIT02
    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:2013-09-20
    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 number2013-003333-15
    A.3Full title of the trial
    A 12 months, prospective, multicenter, open-label, single arm interventional study assessing the safety and tolerability of 0.5 mg ranibizumab in mono/bilateral wet AMD patients in eyes with BCVA below 2/10 and/or second affected eye.
    Studio interventistico, multicentrico, prospettico, in aperto, con un solo gruppo di trattamento, della durata di 12 mesi per valutare la sicurezza e la tollerabilità di ranibizumab 0.5 mg in pazienti affetti da wAMD mono/bilaterale in occhi con BCVA inferiore a 2/10 e/o patologia del secondo occhio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study assessing the safety and tolerability of 0.5 mg ranibizumab in mono/bilateral wet AMD patients in eyes with BCVA below 2/10 and/or second affected eye.
    Studio per valutare la sicurezza e la tollerabilità di ranibizumab 0.5 mg in pazienti affetti da wAMD mono/bilaterale in occhi con BCVA inferiore a 2/10 e/o patologia del secondo occhio.
    A.4.1Sponsor's protocol code numberCRFB002AIT02
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNOVARTIS FARMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityORIGGIO
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390296541
    B.5.5Fax number0039029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 LUCENTIS*INIET 1FL 2,3 MG/0,23 ML
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameLucentis
    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 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
    Mono/bilateral Wet Age related Macular Degeneration (wAMD) in eyes with Best Corrected Visual Acuity (BCVA) below 2/10 and/or second affected eye .
    Degenerazione maculare essudativa legata all’età (Wet Age related Macular Degeneration - wAMD) mono/bilaterale in occhi con miglior acuità visiva corretta (Best Corrected Visual Acuity – BCVA) inferiore a 2/10 e/o patologia del secondo occhio.
    E.1.1.1Medical condition in easily understood language
    Mono/bilateral Wet Age related Macular Degeneration in eyes with Best Corrected Visual Acuity below 2/10 and/or second affected eye .
    Degenerazione maculare legata all’età mono/bilaterale in occhi con miglior acuità visiva corretta inferiore a 2/10 e/o patologia del secondo occhio.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    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
    The primary objective of the present study is to evaluate the annual incidence of both ocular and systemic drug-related adverse events following ranibizumab treatment in patients diagnosed with wAMD and BCVA <2/10 and/or second eye affected, whichever BCVA reported.
    L’obiettivo primario del presente studio è valutare l’incidenza annuale di eventi avversi farmaco-relati a livello oculare e sistemico a seguito del trattamento con ranibizumab in pazienti con diagnosi di wAMD e BCVA <2/10 e/o patologia del secondo occhio, indipendentemente dalla BCVA riportata.
    E.2.2Secondary objectives of the trial
    - Describe the treatment patterns for ranibizumab in this type of population; estimate the proportion of systemic and ocular AEs stratifying by type of patient; - evaluate the incidence rate of AEs by study drug exposure; - evaluate a carry-over effect of exposure to possible previous treatment(s) on the relationship between the rate of AEs and drug exposure; - and evaluate the incidence of new onset second eye with wet AMD diagnosis in patients currently enrolled with unilateral diagnosis.
    - descrivere i regimi di trattamento con ranibizumab in questo tipo di popolazione in termini di: numero complessivo di somministrazioni, numero di visite, intervallo di somministrazione nella patologia bilaterale, numero di ritrattamenti e motivo del ritrattamento, termine del trattamento;
    - stimare la proporzione di eventi avversi sistemici e oculari stratificati per tipo di paziente;
    - valutare l’incidenza degli eventi avversi in relazione all’esposizione al farmaco;
    - valutare l’eventuale effetto carry-over di esposizione ad eventuali precedenti trattamenti sulla relazione tra il tasso di AE e l’esposizione al farmaco;
    - valutare l’incidenza di patologia del secondo occhio di nuova diagnosi in pazienti arruolati al basale con affezione monolaterale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients aged 50 years or above
    - Willing and capable to provide informed written consent
    - Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD
    AND/OR
    - Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
    - Pazienti maschi e femmine con età ≥ 50 anni;
    - Volontà di partecipare allo studio e capacità di firmare il consenso informato;
    - Occhi(o) candidati(o) al trattamento con ranibizumab con BCVA al di sotto di 2/10 a causa di wAMD
    E/O
    - Occhio adelfo candidato al trattamento con ranibizumab, con il primo occhio in trattamento (corrente o pregresso) con ranibizumab, senza limiti legati alla BCVA. Nei pazienti con wAMD bilaterale, il secondo occhio potrà essere incluso solo se il trattamento del primo occhio con ranibizumab è stato eseguito almeno 14 giorni prima.
    E.4Principal exclusion criteria
    - Active intraocular inflammation (grade trace or above) in either eye
    - Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye
    - Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment)
    - Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole
    - Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator’s judgment)
    - History of vitrectomy in the study eye
    - History of stroke or transient ischemic attack
    - Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment
    - Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment
    - Any intraocular surgery in the study eye within 28 days prior to enrollment
    - Women of childbearing potential UNLESS using effective contraception during treatment
    - Pregnant or lactating women
    - Simultaneous participation in a study that includes administration of any investigational drug
    - Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
    - Inability to comply with study procedures.
    - Infiammazione intraoculare attiva (grado traccia o superiore) in uno dei due occhi;
    - Infezione oculare o perioculare attiva (presente o sospetta), ad es. congiuntivite, cheratite, sclerite, uveite, endoftalmite, in uno dei due occhi;
    - Fattori di rischio per rottura dell’epitelio pigmentato retinico (incluso distacco dell’epitelio pigmentato retinico);
    - Patologie oculari che potrebbero confondere l’interpretazione dei risultati del trattamento, compromettere l’acuità visiva, o richiedere un intervento medico o chirurgico durante la durata dello studio, inclusa cataratta, occlusione venosa retinica, distacco di retina o foro maculare;
    - Glaucoma non controllato in uno dei due occhi (IOP ≥ 30 mmHg in terapia o a discrezione del clinico);
    - Anamnesi positiva per vitrectomia nell’occhio in studio;
    - Anamnesi positiva per attacco ischemico transitorio o ictus;
    - Trattamento sistemico con qualsiasi agente inibitore del VEGF entro 90 giorni dall’arruolamento;
    - Trattamento dell’occhio in studio con qualsiasi farmaco anti-angiogenico entro 30 giorni dall’arruolamento;
    - Qualsiasi tipo di chirurgia intraoculare eseguita nell’occhio in studio entro 28 giorni dall’arruolamento;
    - Donne in età fertile A MENO CHE non utilizzino metodi contraccettivi efficaci durante il trattamento;
    - Donne gravide o in allattamento;
    - Concomitante partecipazione a studi clinici che prevedano la somministrazione di farmaci sperimentali;
    - Ipersensibilità nota a ranibizumab o a qualsiasi componente della formulazione di ranibizumab;
    - Incapacità di attenersi alle procedure di studio.
    E.5 End points
    E.5.1Primary end point(s)
    Annual incidence of both ocular and systemic drug-related adverse events following ranibizumab treatment.
    Tasso di incidenza annuale degli eventi avversi oculari e sistemici correlati all’utilizzo di ranibizumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    - Describe the treatment patterns for ranibizumab in this type of population; estimate the proportion of systemic and ocular AEs stratifying by type of patient; evaluate the incidence rate of AEs by study drug exposure; evaluate a carry-over effect of exposure to possible previous treatment(s) on the relationship between the rate of AEs and drug exposure; and evaluate the incidence of new onset second eye with wet AMD diagnosis in patients currently enrolled with unilateral diagnosis.
    - Descrivere i regimi di trattamento con ranibizumab in questo tipo di popolazione in termini di: numero complessivo di somministrazioni, numero di visite, intervallo di somministrazione nella patologia bilaterale, numero di ritrattamenti e motivo del ritrattamento, termine del trattamento; - Stimare la proporzione di eventi avversi sistemici e oculari stratificati per tipo di paziente; - Valutare l’incidenza degli eventi avversi in relazione all’esposizione al farmaco; - Valutare l’eventuale effetto carry-over di esposizione ad eventuali precedenti trattamenti sulla relazione tra il tasso di AE e l’esposizione al farmaco; - Valutare l’incidenza di patologia del secondo occhio di nuova diagnosi in pazienti arruolati al basale con affezione monolaterale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 No
    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 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 concerned150
    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
    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 months6
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    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 state3500
    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)
    Standard therapy
    Terapia standard
    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 Decision2013-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
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