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    Summary
    EudraCT Number:2013-001874-12
    Sponsor's Protocol Code Number:C-12-071
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-12
    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 ConcernedSpain - AEMPS
    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
    Estudio clínico aleatorizado, doble enmascarado, controlado con vehículo para evaluar la seguridad y la eficacia de Nepafenaco 0,3 % en suspensión oftálmica para mejorar los resultados clínicos después de una operación de cataratas en pacientes diabéticos
    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
    Nepafenaco una vez al día para el edema macular ? Estudio 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 Eye Care (UK) Ltd
    B.5.2Functional name of contact pointHead of EURMEA Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFrimley Business Park, Frimley
    B.5.3.2Town/ cityCamberley, Surrey
    B.5.3.3Post codeGU16 7SR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441276673389
    B.5.6E-mailzubair.hussain@alcon.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 NEVANAC 3 mg/ml
    D.2.1.1.2Name 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, suspension
    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.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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, suspension
    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
    Operación de cataratas en pacientes diabéticos
    E.1.1.1Medical condition in easily understood language
    Cataract
    Cataratas
    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.
    Demostrar la superioridad de Nepafenaco 0,3 % en suspensión oftálmica administrado una vez al día en relación con el vehículo de Nepafenaco basada en los resultados clínicos en pacientes diabéticos después de una operación de cataratas
    E.2.2Secondary objectives of the trial
    Not applicable
    No procede.
    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.
    - Presentar una catarata y tener previsto someterse a una extracción de catarata mediante facoemulsificación con implantación de una lente intraocular de cámara posterior en la cápsula del cristalino.
    - Antecedentes de diabetes de tipos 1 o 2 y retinopatía diabética no proliferativa (RDNP) (leve, moderada o grave) en el ojo del estudio.
    - Agudeza visual mejor corregida (BCVA) según el estudio del tratamiento precoz de retinopatía diabética (ETDRS) de 73 letras o peor en el ojo del estudio para poder participar en él. Debe haber expectativas, en opinión del investigador, de que el ojo del estudio del paciente mejorará en BCVA después de la operación
    - Los pacientes deben comprender y firmar un formulario de consentimiento informado aprobado.
    - Se pueden aplicar otros criterios de inclusión definidos en el protocolo.
    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 anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol. Subjects with known medical history of intolerance
    to fluorescein are also excluded;
    - Participation in any other clinical study within 30 days of the screening visit;
    - 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.
    - Preexistencia de edema macular en el ojo del estudio.
    - Antecedentes en el ojo del estudio de desprendimiento de retina, degeneración macular exudativa relacionada con la edad (DMAE húmeda), enfermedad ocular inflamatoria crónica o recurrente, o procedimientos anteriores.
    - Operación de cataratas en el otro ojo después de la aleatorización y antes de la visita posoperatoria del estudio del día 90 o en la salida del estudio.
    - Múltiples procedimientos para el ojo del estudio durante la operación quirúrgica de cataratas/implante de la lente intraocular (LIO).
    - Uso de medicamentos excluidos incluyendo fármacos antiinflamatorios no esteroideos (AINEs) y esteroides, como se especifica en el protocolo. También se excluye a los sujetos con antecedentes médicos conocidos de intolerancia a la fluoresceína.
    - Participación en cualquier otro estudio clínico en los 30 días anteriores a la visita de selección.
    - Mujeres en edad fértil que están en período de lactancia, obtienen un resultado positivo en la prueba de embarazo en orina en el momento de la selección, no están dispuestas a someterse a una prueba de embarazo en orina en los momentos de su entrada o salida del estudio, pretenden quedarse embarazadas en el transcurso del estudio, o no aceptan usar métodos anticonceptivos adecuados durante el transcurso del estudio.
    - Se pueden aplicar otros criterios de exclusión definidos en el protocolo.
    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
    Proporción de pacientes con mejora de la BCVA en ?15 letras desde el inicio preoperatorio hasta el día 14 y mantenida hasta el día 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Day 14, Day 30, Day 60 and Day 90
    Incial, dia 14, dia 30, dia 60 y dia 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
    - Proporción de pacientes que presenta edema macular (que se define como un aumento de al menos el 30 % desde el inicio preoperatorio en el grosor macular del subcampo central) en los 90 días siguientes a la operación de cataratas (medido mediante SD-OCT)
    - Proporción de pacientes con mejora de la BCVA en ?15 letras desde el inicio preoperatorio hasta el día 90
    - Proporción de pacientes con mejora de la BCVA en ?15 letras desde el inicio preoperatorio hasta el día 60
    E.5.2.1Timepoint(s) of evaluation of this end point
    As for primary endpoint
    Como para variable principal
    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) 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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Australia
    Austria
    Colombia
    France
    Germany
    Hungary
    Italy
    Spain
    Israel
    Mexico
    Peru
    Philippines
    Singapore
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    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
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    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
    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 Decision2013-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-28
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