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    EudraCT Number:2013-001874-12
    Sponsor's Protocol Code Number:C-12-071
    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:2013-09-16
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001874-12
    A.3Full title of the trial
    Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To
    Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3%
    For Improvement In Clinical Outcomes Among Diabetic Subjects Following
    Cataract Surgery
    Studio clinico randomizzato, in doppio cieco, controllato con placebo, per valutare la sicurezza e l’efficacia di Nepafenac Collirio, Sospensione allo 0,3% nel miglioramento degli esiti clinici in seguito ad intervento chirurgico di cataratta in pazienti diabetici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nepafenac Once Daily for Macular Edema - Study 2
    Nepafenac una volta al giorno per l’edema maculare - studio 2
    A.4.1Sponsor's protocol code numberC-12-071
    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 SponsorAlcon Research, Ltd
    B.1.3.4CountryUnited States
    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 supportAlcon Research, Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlcon Italia S.p.A.
    B.5.2Functional name of contact pointUfficio Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressVia G.Richard 1/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20143
    B.5.4Telephone number003902803226
    B.5.5Fax number0039028139499
    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 NEVANAC 3 mg/ml
    D. of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd
    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.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEPAFENAC
    D.3.9.3Other descriptive nameNEPAFENAC
    D.3.9.4EV Substance CodeSUB09197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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. 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cataract surgery in diabetic patients
    Chirurgia della cataratta in pazienti diabetici
    E.1.1.1Medical condition in easily understood language
    Cataract surgery
    Chirurgia della cataratta
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3%
    dosed once daily relative to Nepafenac Vehicle based upon clinical
    outcomes among diabetic subjects following cataract surgery.
    Dimostrare la superiorità di Nepafenac 0,3% collirio, sospensione, somministrato una volta al giorno rispetto a Placebo (Nepafenac Veicolo) in base agli esiti clinici in seguito ad intervento di cataratta in pazienti diabetici.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Planned cataract extraction by phacoemulsification with implantation
    of a posterior chamber intraocular lens;
    - History of Type 1 or 2 diabetes and non-proliferative diabetic
    retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
    - Best-corrected visual acuity (BCVA) of 73 letters or worse in the study
    eye with expectation of improvement after surgery;
    - Understand and sign an informed consent document;
    - Other protocol-defined inclusion criteria may apply.
    1. I soggetti devono avere almeno 18 anni, essere affetti da cataratta ed avere in programma un intervento di rimozione della cataratta con facoemulsificazione e impianto di lente intraoculare da camera posteriore nella capsula del cristallino
    2. I soggetti devono avere un’anamnesi di diabete di Tipo 1 o 2 e retinopatia diabetica non proliferativa o RDNP (lieve, moderata o grave) nell’occhio in studio, secondo la Scala Internazionale di Valutazione della Gravità Clinica della Retinopatia Diabetica e la conferma del Reading Center a cui è affidata la valutazione centralizzata dei dati.
    3. L’occhio in studio allo screening (prima dell’intervento) deve avere un’acuità visiva corretta al meglio (BCVA) ETDRS uguale o inferiore a 73 lettere.
    4. L’occhio in studio deve avere, secondo il parere dello Sperimentatore, aspettative di miglioramento della BCVA dopo l’intervento chirurgico.
    5. I soggetti devono essere in grado di comprendere e firmare un consenso informato che sia stato approvato da un Comitato etico indipendente o da un Comitato di revisione istituzionale.
    E.4Principal exclusion criteria
    - Pre-existing macular edema in the study eye;
    - History in the study eye of retinal detachment, wet age-related macular
    degeneration, chronic or recurrent
    inflammatory eye disease, or prior procedures;
    - Planned cataract surgery in the fellow eye prior to the Day 90
    postoperative study visit or through study exit;
    - Planned multiple procedures for the study eye during the
    cataract/intraocular lens;
    - Use of exclusionary medications, including nonsteroidal antiinflammatory
    drugs (NSAIDs) and steroids, as specified in protocol;
    - Participation in any other clinical study within 30 days of the screening
    - Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
    - Other protocol-defined exclusion criteria may apply.
    1.Edema maculare nell’occhio in studio già presente e confermato da tomografia a coerenza ottica con dominio spettrale (SD-OCT) e parere del Reading Center (spessore maculare del sottocampo centrale ≥ 320 μm con Spectralis o ≥ 300 μm con Cirrus)
    2. Anamnesi nell’occhio in studio di distacco di retina, degenerazione maculare legata all’età (DME) essudativa, cronica o ricorrente
    3. Procedure programmate di intervento di cataratta nell’occhio contro-laterale dopo la randomizzazione e prima della visita post-operatoria al Giorno 90 o dell’uscita dallo studio
    4. Procedure multiple nell’occhio in studio durante l’intervento di cataratta/impianto di lente intraoculare (IOL)
    5. Uso intraoculare o perioculare di steroidi nell’occhio in studio
    6. partecipazione ad altri studi clinici nei 30 giorni antecedenti allo screening
    7. Le pazienti in età fertile (non sterilizzate chirurgicamente o non in menopausa) non possono partecipare allo studio se sussiste una delle seguenti condizioni:
    a. stanno allattando al seno
    b. hanno un test di gravidanza (urine) positivo allo screening
    c. non accettano di sottoporsi a un test di gravidanza (urine) al momento dell’ingresso o dell’uscita dallo studio
    d. hanno intenzione di affrontare una gravidanza durante il periodo dello studio, oppure
    e. non accettano di utilizzare metodi anticoncezionali adeguati per la durata dello studio.
    8. Per ulteriori criteri di esclusione fare riferimento al protocollo dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with best-corrected visual acuity (BCVA)
    improvement of ≥ 15 letters from preoperative baseline to Day 14 and
    maintained through Day 90
    Proporzione di soggetti con miglioramento della BCVA ≥ 15 lettere al Giorno 14 rispetto al basale pre-operatorio e suo mantenimento fino al Giorno 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Day 14, Day 30, Day 60 and Day 90
    basale, giorno 14, giorno 30, giorno 60 e giorno 90.
    E.5.2Secondary end point(s)
    - Proportion of subjects who develop macular edema (defined as ≥ 30%
    increase from pre-operative baseline in central subfield macular
    thickness) within 90 days following cataract surgery
    - Proportion of subjects with BCVA improvement of ≥ 15 letters from
    preoperative baseline to Day 90
    - Proportion of subjects with BCVA improvement of ≥ 15 letters from
    preoperative baseline to Day 60
    • Proporzione di soggetti che sviluppano edema maculare (definito come aumento ≥ 30% rispetto al basale pre-operatorio dello spessore maculare del sottocampo centrale) entro 90 giorni dall’intervento (misurato mediante SD-OCT).
    • Proporzione di soggetti con miglioramento della BCVA ≥ 15 lettere al Giorno 90 rispetto al basale pre-operatorio
    • Proporzione di soggetti con miglioramento della BCVA ≥ 15 lettere al Giorno 60 rispetto al basale pre-operatorio
    • Proporzione di soggetti con peggioramento della BCVA in qualunque visita > 5 lettere perse rispetto al Giorno 7
    • Proporzione di soggetti con peggioramento della BCVA in qualunque visita > 10 lettere perse rispetto al Giorno 7
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Day 14, Day 30, Day 60 and Day 90
    basale, giorno 14, giorno 30, giorno 60 e giorno 90.
    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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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.8.5The 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 177
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 413
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 590
    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)
    Not different from the expected normal treatment for the condition
    Non diverse dal trattamento solitamento riservato alla condizione del paziente
    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 Decision2013-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
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