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    Summary
    EudraCT Number:2017-001416-11
    Sponsor's Protocol Code Number:PROCEF/EYE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-10
    Trial 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 number2017-001416-11
    A.3Full title of the trial
    Assessment of macular thickness after non-traumatic cataract surgery associated to intracamerular injection of Cefuroxima prepared at the hospital vs Prokam.
    Evaluación del grosor macular tras cirugía de cataratas no traumática
    asociada a la inyección en cámara anterior de Cefuroxima de preparación
    hospitalaria vs Prokam
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of macular thickness before and after cataract surgery with an antibiotic from two ways of preparation.
    Comparación del grosor macular antes y después de cirugía de cataratas no traumática asociada a antibiótico procedente de dos vías de preparación.
    A.4.1Sponsor's protocol code numberPROCEF/EYE
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital de l'Esperança
    B.5.2Functional name of contact pointServicio de Oftalmología
    B.5.3 Address:
    B.5.3.1Street AddressSt Josep de la Muntanya,12
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933674100
    B.5.5Fax number0034933674266
    B.5.6E-mail90441@parcdesalutmar.cat
    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 Cefuroxima NORMON 750mg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Normon SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFUROXIME SODIUM
    D.3.9.1CAS number 56238-63-2
    D.3.9.4EV Substance CodeSUB01140MIG
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 CEFUROXIMA PROKAM
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Thea SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Intraocular instillation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFUROXIME SODIUM
    D.3.9.1CAS number 56238-63-2
    D.3.9.4EV Substance CodeSUB01140MIG
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pseudophakic macular edema
    Edema macular pseudofáquico
    E.1.1.1Medical condition in easily understood language
    Macular edema after cataract surgery
    Edema macular tras cirugía de 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 compare the incidence of macular thickness in patients in the
    prophylaxis of endophthalmitis realized after cataract surgery not complicated with cefuroxime preparations with that realized with
    Prokam.
    Comparar la incidencia de grosor macular aumentado en aquellos
    pacientes en los que se realice profilaxis de endoftalmitis tras cirugía de
    catartas no complicada con cefuroxima de preparación hospitalaria con
    respecto a aquellos en los que se realice con Prokam.
    E.2.2Secondary objectives of the trial
    To examine the incidence of macular edema and clinically and not clinically significant in both groups of the clinical trial.
    Examinar la incidencia de edema macular clínicamente significativo y no
    clínicamente significativo en ambos grupos de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults patients of both genres aged between 18 and 99 years.
    • Patients with cataracts 2 or 3 graded,by the Established in the
    classification of LOCS III.
    • Patients who have signed inform consent indicating that they have
    been informed regarding all
    the clinical trial aspects, or in the event that the subjects of the trial are
    incapacitated, signature of consent by the family member or legally
    designated representative.
    Pacientes adultos de ambos sexos de edades comprendidas entre los 18
    y los 99 años.
    • Pacientes con cataratas grado 2 o 3, según lo establecido por la clasificación LOCS III.
    • Pacientes que firmen el consentimiento informado indicando que han
    sido informados de todos los aspectos pertinentes sobre el ensayo o en
    el caso que los sujetos del ensayo sean incapaces, firma del
    consentimiento por parte del familiar o representante legalmente
    designado.
    E.4Principal exclusion criteria
    A. preoperative:
    -Alergia or hypersensitivity to β-lactámic antibiotic or to any of the
    excipients of the clinical trial drugs.
    -Pacientes with no proliferative diabetic retinopathy, moderate or
    severe diabetic macular edema or diabetic retinopathy proliferation
    (any grade).
    - History of uveitis, macular degeneration associate in the Middle (AMD)
    type of exudative or atrophic, diabetic retinopathy, vein occlusion or
    central retinal vein branch, epiretinal membrane (SEM) and retinitis
    pigmentosa.
    -Patients with macular edema in OCT macular preoperatorio proofing
    whatever the etiology.
    - Patients with glaucoma treatment with prostaglandin analogsnot been
    suspended at least one month before the surgery.
    B. Post-operative:
    - Intraoperative complications: posterior capsule rupture, vitreous LOST,
    iris-vitreous incarceration.
    - Postoperatory complications: lack of compliance of treatment of the sheduled postoperative.
    - Lack of compliance of the protocol.
    -Alergia o hipersensibilidad a antibióticos β-lactámicos o a alguno de los
    excipientes de los fármacos del ensayo clínico (ver anexo IV, fichas
    técnicas).
    -Pacientes con retinopatía diabética no proliferativa moderada o severa,
    edema macular diabético de cualquier grado o retinopatía diabética
    proliferativa.
    - Antecedentes de uveítis, Degeneración Macular Asociada a la Edad
    (DMAE) de tipo exudativo o atrófico, retinopatía diabética, oclusión de
    vena central o rama venosa de la retina, membrana epirretiniana (MER)
    o retinosis pigmentaria.
    -Pacientes con edema macular objetivado en la prueba de OCT macular
    preoperatorio, de cualquier etiología.
    - Pacientes con glaucoma en tratamiento con análogos de las
    prostaglandinas que no hayan sido suspendidos mínimo un mes antes de
    la cirugía.
    B. Postoperatorios:
    - Complicaciones intraoperatorias: rotura de cápsula posterior, pérdida
    de vítreo, incarceración iris-vítreo.
    - Complicaciones postoperatorias: falta de cumplimiento del tratamiento
    postoperatorio pautado.
    - Falta de cumplimiento del seguimiento programado según protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    -Macular thickness(μm), OCT imaged, by OCT Cirrus (Zeiss, Oberkochen,
    Germany) or Swept Source OCT Triton (Topcon, Tokyo, Japan)
    -Grosor macular (μm) valorado en imagen OCT mediante OCT Cirrus
    (Zeiss, Oberkochen, Alemania) or Swept Source OCT Triton (Topcon, Tokio, Japón)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before cataract surgery until 5 +/- 1 weeks after
    Antes de la cirugía de cataratas hasta 5 +/- semanas
    E.5.2Secondary end point(s)
    Visual acuity by ETDRS test
    Agudeza visual medida mediante el test ETDRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before cataract surgery until 5 +/- 1 weeks after
    Antes de la cirugía de cataratas hasta 5 +/- semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Última visita del último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state622
    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 receive adequate treatment from their physician.
    Los pacientes recibirán el tratamiento que su médico considere
    oportuno.
    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 Decision2018-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-10
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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