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    Summary
    EudraCT Number:2011-002731-26
    Sponsor's Protocol Code Number:CRFB002DIT01
    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:2011-12-29
    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 number2011-002731-26
    A.3Full title of the trial
    An open-label, multi-center, expanded access program of ranibizumab in patients with visual impairment due to diabetic macular edema for whom no suitable therapeutic alternatives exist.
    Programma in aperto, multicentrico, di accesso allargato a ranibizumab, in pazienti con diminuzione visiva causata dall`™edema maculare diabetico per i quali non esistano adeguate alternative terapeutiche.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An expanded access program of ranibizumab in patients with visual impairment due to diabetic macular edema for whom no suitable therapeutic alternatives exist.
    Programma di accesso allargato a ranibizumab in pazienti con diminuzione visiva causata dall’edema maculare diabetico per i quali non esistano adeguate alternative terapeutiche.
    A.4.1Sponsor's protocol code numberCRFB002DIT01
    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 number+39 02 96541
    B.5.5Fax number+39 02 9659066
    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 0,23ML 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    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.3.4Pharmaceutical 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 µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Diabetic macular edema
    Edema maculare diabetico
    E.1.1.1Medical condition in easily understood language
    Diabetic macular edema
    Edema maculare diabetico
    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 LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic 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 provide early access to ranibizumab in patients with macular edema and visual impairment secondary to diabetes mellitus for whom no suitable therapeutic alternatives exist (i.e. existing therapies, e.g. laser photocoagulation, have failed or are not indicated).
    Consentire un accesso allargato a ranibizumab ai pazienti con diminuzione visiva causata da DME per i quali non esistano adeguate alternative terapeutiche (cioè le terapie esistenti, ad esempio la fotocoagulazione laser, hanno fallito o non sono indicate).
    E.2.2Secondary objectives of the trial
    To generate, in an Italian population resembling that of future clinical practice, additional safety and tolerability data of ranibizumab in patients with visual impairment due to DME, administered according to the label approved by CHMP.
    Produrre ulteriori dati di sicurezza e tollerabilità di ranibizumab, somministrato in accordo con la scheda tecnica approvata dal CHMP in pazienti con diminuzione dell’acuità visiva causata da DME, in una popolazione italiana simile a quella identificabile nella futura pratica clinica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients >18 years of age who have signed an informed consent. 2. Patients with Type 1 or Type 2 DM (according to ADA or WHO guidelines). 3. Patients diagnosed with visual impairment due to focal or diffuse DME in at least one eye for whom no suitable therapeutic alternatives exist (i.e. existing therapies, e.g. laser photocoagulation, have failed or are not indicated). 4. If both eyes are eligible, the one with the worst visual acuity, as assessed at Visit 1, will be selected for treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment.
    1. Pazienti adulti, di età &gt; 18 anni, di entrambi i sessi, che hanno firmato consenso informato scritto prima di iniziare ogni procedura prevista dal programma. 2. Pazienti con DM di tipo I o di tipo II (in accordo con le linee guida ADA o WHO). 3. Pazienti con diminuzione visiva causata da DME focale o diffusa in almeno un occhio e per i quali non esistano adeguate alternative terapeutiche (cioè le terapie esistenti, ad esempio la fotocoagulazione laser, hanno fallito o non sono indicate). 4. Se entrambi gli occhi sono eleggibili al trattamento, sarà selezionato per il programma l’occhio con l’acuità visiva peggiore alla visita 1, a meno che, sulla base di valide motivazioni mediche, lo sperimentatore non ritenga l’altro occhio più appropriato al trattamento.
    E.4Principal exclusion criteria
    Ocular concomitant conditions/ diseases:1.Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity while on treatment;2.Active intraocular inflammation in either eye;3.Any active infection in either eye;4.History of uveitis in either eye;5.Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques;6.Ocular disorders in the study eye that may confound interpretation of results, compromise visual acuity or require medical or surgical intervention during the program period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause;7.Uncontrolled glaucoma in either eye;8.Neovascularization of the iris in either eye;9.Evidence of vitreomacular traction in either eye;10.Active proliferative diabetic retinopathy in the study eye;11.Patients who are monocular or have a BCVA score in the non-study eye ≤ 24 letters at Visit 1. Ocular treatments:12.Panretinal laser photocoagulation in the study eye within 6 months prior to program entry;13.Focal/grid laser photocoagulation in the study eye within 3 months prior to program entry;14.Treatment with anti-angiogenic drugs within 1 month prior to enrollment;15. Any intraocular surgery in the study eye within 3 months prior to enrollment;16.History of vitrectomy in study eye. Systemic conditions or treatments:17.Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl;18.Patient with HbA1c ≥ 12%;19.Hypertension uncontrolled by medication;20.Untreated hypertension or change in antihypertensive treatment within 3 months preceding screening;21.Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation. Compliance/ Administrative:22.Pregnant or nursing (lactating) women;23.Women of childbearing potential UNLESS using effective contraception during treatment;24.Inability to comply with program procedures.
    Condizioni oculari concomitanti/patologie: 1.Presenza di condizioni cliniche concomitanti nell’occhio in studio che, a giudizio dello sperimentatore, potrebbero precludere in corso di trattamento un miglioramento dell’acuità visiva nell’occhio selezionato;2.Tracce o evidenze maggiori di infiammazione intraoculare attiva in uno dei 2 occhi;3.Qualsiasi infezione attiva in uno dei due occhi;4.Storia di uveite in uno dei due occhi;5.Danno strutturale di dimensioni comprese entro mezzo diametro papillare dal centro della macula dell’occhio in studio che potrebbe precludere un miglioramento dell’acuità visiva dopo la risoluzione dell’edema maculare, incluse atrofia dell’epitelio pigmentato retinico, fibrosi sottoretinica, cicatrici da laser, membrana epiretinica che coinvolge la fovea o placche di essudati duri organizzati;6.Patologie oculari nell’occhio in studio che possono confondere l’interpretazione dei risultati, compromettere l’acuità visiva o richiedere intervento medico o chirurgico nel corso del programma, inclusi cataratta, occlusione vascolare retinica, distacco retinico, foro maculare, o neovascolarizzazione coroidea da qualunque causa;7.Glaucoma non controllato in uno dei due occhi allo screening;8.Neovascolarizzazione dell’iride in uno dei due occhi;9.Evidenze di trazione vitreomaculare in uno dei due occhi;10.Retinopatia diabetica proliferante attiva nell’occhio in studio;11.Pazienti monocoli o con BCVA nell’occhio non in studio (l’altro occhio) ≤ 24 lettere alla Visita 1.Terapie oculari:12.Fotocoagulazione laser panretinica eseguita nell’occhio in studio nei 6 mesi precedenti l’inizio del programma;13.Fotocoagulazione laser focale/griglia nell’occhio in studio eseguita nei 3 mesi precedenti l’inclusione nel programma;14. Trattamento con farmaci antiangiogenici nel mese precedente l’arruolamento;15.Qualsiasi chirurgia intraoculare eseguita nell’occhio in studio nei 3 mesi precedenti l’arruolamento;16.Storia di vitrectomia eseguita nell’occhio in studio.Condizioni sistemiche o trattamenti:17.Insufficienza renale che richiede dialisi o trapianto renale o insufficienza renale con livelli di creatinina &gt; 2.0mg/dl;18.Pazienti con HbA1c ≥ 12%;19.Ipertensione non controllata dalla terapia;20.Ipertensione non trattata o cambiamento del trattamento ipertensivo in corso nei 3 mesi precedenti lo screening;21.Ipersensibilità nota al ranibizumab o a qualsiasi componente presente nella formulazione di ranibizumab.Compliance dei pazienti / aspetti amministrativi:22.Donne in gravidanza o allattamento;23.Donne in età fertile A MENO CHE utilizzino validi metodi contraccettivi nel corso del periodo di trattamento;24. Incapacità di attenersi alle procedure previste dal programma.
    E.5 End points
    E.5.1Primary end point(s)
    No formal statistical tests will be performed.
    Non saranno eseguiti test statistici formali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N.A.
    N.A.
    E.5.2Secondary end point(s)
    No formal statistical tests will be performed.
    Non saranno eseguiti test statistici formali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    N.A.
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial700
    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 concerned33
    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
    Ranibizumab will be provided until national reimbursement and effective availability for DME indication in the centre to which the patients included in the program refer.
    Ranibizumab sarà fornito fino a quando il farmaco non otterrà la rimborsabilità a livello nazionale e sarà effettivamente disponibile per l’indicazione DME nel centro al quale i pazienti partecipanti a questo programma riferiscono.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 630
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 700
    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)
    Patients will continue to take the treatment, being reimbursed.
    I pazienti continueranno ad assumere il farmaco in studio, essendo rimborsato.
    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 Decision2011-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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