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    Summary
    EudraCT Number:2011-004613-17
    Sponsor's Protocol Code Number:20110912DME1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-20
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-004613-17
    A.3Full title of the trial
    The effect of intravitreal injections of Lucentis (ranibizumab) on retinal function in diabetic patients with diabetic macular edema and visual impairment
    Effekten av, i glaskroppen injicerat läkemedel, Lucentis (ranibizumab) på näthinnans funktion hos diabetiker med synförsämring till följd av diabetiskt maculaödem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Lucentis (ranibizumab) on retinal function in diabetic patients with visual impairment and diabetic svelling of the makula
    Effekt av Lucentis ( ranibizumab), givet i glaskroppen i ögat, på näthinnans funktion hos diabetiker med synnedsättning och svullnad i gula fläcken
    A.4.1Sponsor's protocol code number20110912DME1
    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 SponsorInst of Ophtalmology Lund University hospital
    B.1.3.4CountrySweden
    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 supportNovartis Sverige AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInst of Ophtalmology Lund University Hospital
    B.5.2Functional name of contact pointDoc Monica Lövestam Adrian
    B.5.3 Address:
    B.5.3.1Street AddressEyeclinic SUS Skanes University Hospital
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22185
    B.5.3.4CountrySweden
    B.5.4Telephone number+4646171650
    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 (ranibizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Sverige AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 IMPIntraocular use
    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 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
    Diabetic makula edema with visual impairment
    Diabetes makula ödem med synnedsättning
    E.1.1.1Medical condition in easily understood language
    Patients with diabetes mellitus and diabetic svelling of the makula and visual impairment
    Patienter med sockersjuka som har ögonbottenförändringar orsakade av sockersjukan med svullnad över gula fläcken och synnedsättning
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLGT
    E.1.2Classification code 10012653
    E.1.2Term Diabetic complications
    E.1.2System Organ Class 10014698 - Endocrine 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 study if intravitreal injection of Lucentis gives an improved visual function and a reduction of macularedema. And also objectively evaluate changes in the total retinal function and makular function with mfERG och ff ERG.
    Att studera om intravitreal Lucentis injektion ger förbättrad synfunktion och minskning av makulaödemet. Samt att objecktivt kartlägga förändringar i den totala näthinnefunktionen och makulafunktionen med mfERG och ffERG.
    E.2.2Secondary objectives of the trial
    To study if Lucentis (ranibizumab) given as an injection into the eye can improv vision and reduce the svelling of the macula. And also to evaluate changes in the retinalcell function and makular cellfunction by using an non-invasive method to measure the electical activity of the retina.
    Att studera om Lucentis (ranibizumab) givet in i glaskroppen kan förbättra synen och minska på svullnaden i gula fläcken. Samt att objektivt kartlägga retinacellerna function genom att mäta den elektriska aktiviteten i näthinnan.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with type 1 or 2 diabetes mellitus
    patients with clinical significant macular edema
    patients with visual impairment <0.7 (Snellen)
    Patients with no previous lasertreatment or other treatment for macular edema
    Patienter med diabetes
    patienter med klinisk signifikant makula ödem
    patienter med synnedsättning <0,7 ( Snellen)
    Patienter som inte tidigare fått laserbehandling eller annan behandling för sitt makula ödem
    E.4Principal exclusion criteria
    1. Patients with active proliferative retinopathy
    2. Duration of macular edema> two years
    3. Cataract which causes impaired VA
    4. HbA1c > 10 at baseline
    5. B-glucos > 20 at baseline
    6. Pregnant or nursing women
    7. Fertile women not using effective contraception
    8. Patients with active och suspected infection in our around the eye
    9. Patientes with severe intraocular inflammation
    10. Patients with uncontrolled intraocular pressure (IOP) <25 mmHg in spite of treatment 11. Intraocular surgery during the last 3 months befor enrollment
    12. Previous treatment for retinaldisease such as trombosis or diabeticretinophaty
    1. Patienter med aktiv proliferativ retinopati
    2. Duration av makulaödemet > två år

    3. HbA1c > 10 % vid baslinjen
    4. B-glukos > 20 mmol/l vid baslinjen
    5. Gravida och ammande kvinnor
    6. Kvinnor i fertil ålder som inte har adekvat kontraception
    7. Patienter med aktiva eller misstänkta infektioner i eller runt ögat.
    8. Patienter med aktiv svår intrakulär inflammation
    9. Patienter med okontrollerat intraokulärt tryck (IOP) >25 mmHg trots behandling
    10. Genomgången intraokulär kirurgi de senaste 3 månaderna
    11. Tidigare behandling för näthinnesjukdom såsom trombos eller diabetesretinopati
    E.5 End points
    E.5.1Primary end point(s)
    Effect on retinalcell and macular cellfunction of treatment with ranibizumab
    Effekt på retinala och makula cellers function vid behandling med ranibizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline one and 3 months after injection with ranibizumab
    vid baslinjen efter 1 och 3 månader efter injection med ranibizumab
    E.5.2Secondary end point(s)
    to study if the changes in retinalfunction correlate to visual improvment and morphology changes on Optical Coherance Tomography (OCT)
    att studera om ändringar retinafunctionen korrelerar med synförbättring och med morfologiska förändringar mät med Optical Coherance Tomografi (OCT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    OCT will be done at baseline, 1 and 3 months after injection with ranibizumab. Visual acuity will be measured at every visit, 0, 1,2,3 months
    OCT kommer att mätas vid baslinjen samt 1 och 3 månader efter injection av ranibizumab. Synskärpa kommer att mätas vid varje återbesök, 0, 1, 2, 3 månader.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    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.8.3 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
    End of trial is last visit of last subject
    Studien är slut när sista patienten gjort sitt sista besök
    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 months3
    E.8.9.1In the Member State concerned days
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 state20
    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)
    After study completion it is the treatening physician who decide if/when and how the continues treatment with ranibizumab or laser or a combination of both for DME will be conducted. The continues treatment after the studyend do not differ from expected normal treatment.
    Efter avslutad studie är det den behandlande läkare som beslutar om/när och hur vidare behandling med ranibizumab eller laser, eller en kombination av de två mot DME skall ske eller inte. Den fortsatta behandlingen skiljer sig inte från vanlig klinisk praxis behandling av detta tillstånd.
    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 Decision2011-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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