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    Summary
    EudraCT Number:2013-003056-21
    Sponsor's Protocol Code Number:ReCaLL-2013
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-18
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-003056-21
    A.3Full title of the trial
    Evaluation of an additional therapeutic approach to diabetic macular edema by combining standard therapy (intravitreal injection of a VEGF‐inhibitor) with micropulse diode laser treatment in a randomized, controlled proof of concept study
    Überprüfung einer ergänzenden Therapie des diabetischen Makulaödems mit dem Diodenlaser zur Standardtherapie mit VEGF-Inhibitoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Überprüfung einer ergänzenden Therapie des diabetischen Makulaödems mit dem Diodenlaser zur Standardtherapie mit VEGF-Inhibitoren
    A.3.2Name or abbreviated title of the trial where available
    ReCaLL
    A.4.1Sponsor's protocol code numberReCaLL-2013
    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 SponsorGWT-TUD GmbH
    B.1.3.4CountryGermany
    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 Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGWT-TUD GmbH
    B.5.2Functional name of contact pointMedical Consulting
    B.5.3 Address:
    B.5.3.1Street AddressBlaswitzer Str. 43
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number004935125933189
    B.5.5Fax number004935125933111
    B.5.6E-mailmedical.consulting@gwtonline.de
    D. IMP Identification
    D.IMP: 1
    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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ldt.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 IMPIntravitreal 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 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.IMP: 2
    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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ldt.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 IMPIntravitreal 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 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
    visual impairment due to diabetic macular edema
    Patienten, die unter einem klinisch signifikanten Makulaödem und daraus resultierender Visusminderung leiden
    E.1.1.1Medical condition in easily understood language
    visual impairment due to diabetic macular edema
    Patienten, die unter einem klinisch signifikanten Makulaödem und daraus resultierender Visusminderung leiden
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if a combination therapy with micropulse diode laser treatment shows non-inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only) as measured by best corrected visual acuity (BCVA)
    Evaluierung, ob durch eine Kombination der intravitrealen Therapie von Ranibizumab mit einem gepulsten Diodenlaser keine Unterlegenheit in Bezug auf den bestkorrigierten Visus im Vergleich zur Standardtherapie (alleinige Injektion von Ranibizumab in den Glaskörper) besteht
    E.2.2Secondary objectives of the trial
    To evaluate the influence of a combination therapy of diabetic macular edema with micropulse diode laser and Lucentis® on central macular thickness measured by SD-OCT and
    To evaluate the influence of a combination therapy of diabetic macular edema with micropulse diode laser and Lucentis® on number of treatments with Lucentis® in comparison to standard therapy (intravitreal injection of ranibizumab only)
    Evaluierung, ob die Kombinationstherapie im Vergleich zur Standardtherapie zu einer stärkeren Reduktion der Makuladicke führt (gemessen mit SD-OCT) und ob die Anzahl der notwendigen Ranibizumab Injektionen in den Glaskörper verringert werden kann
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients at least 18 years with DME and 0.05 < BCVA < 0.6 or retinal thickness >300 µm (determined by SD-OCT)
    - Patienten, die mindestens 18 Jahre alt sind und unter einem klinisch signifikanten Makulaödem und daraus resultierender Visusminderung leiden
    - Bestkorrigierter Fernvisus >0.05 und <0.6 oder
    - Zentrale Netzhautdicke >300 μm (bestimmt mit SD-OCT)
    E.4Principal exclusion criteria
    - Severe ischemic maculopathy of the study eye
    - Active neovascularization of iris or retina in the study eye
    - History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
    - Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
    - Advanced glaucoma with central defects of the visual field in study eye
    - Retinal pathologies with reduced visual (e.g. central scars, age related macular degeneration) in study eye
    - Retinal vascular occlusion in medical history of study eye
    - Active or suspected ocular or periocular infections
    - Active intraocular inflammation in study eye
    - Intraocular surgery of study eye within the last 6 months
    - Laser therapy of study eye within the last 6 months
    - Systemic steroid therapy within the last 3 month
    - Uncontrolled blood sugar or blood pressure
    - Pregnant or breast feeding woman and woman without adequate method of contraception
    - Schwere ischämische Makulopathie des Studienauges
    - Aktive Neovaskularisationen der Iris oder Retina des Studienauges
    - Intravitreale Gabe eines VEGF-Inhibitors oder Steroidtherapie des Studienauges innerhalb der letzten 3 Monate
    - Visuslimitierende Erkrankungen des vorderen Augenabschnittes (z.B. Hornhauttrübungen, fortgeschrittene Katarakt)
    - Fortgeschrittenes Glaukom mit zentralen Gesichtsfelddefekten im Studienauge
    - Visuslimitierende Netzhautpathologien (z.B. zentrale Narben, altersabhängige Makuladegeneration) im Studienauge
    - Zustand nach retinalem Gefäßverschluss im Studienauge
    - Aktive oder vermutete okuläre oder periokuläre Infektion und Patienten mit aktiver Uveitis
    - Operation des Studienauges innerhalb der letzten 6 Monate
    - Lasertherapie des Studienauges innerhalb der letzten 6 Monate
    - Systemische Steroidtherapie innerhalb der letzten 3 Monate
    - Entgleister Blutzucker (HbA1c >10%) oder Blutdruck (> 170/110 mmHg)
    - Schwangere oder stillende Frauen und Frauen ohne adäquate Verhütungsmethode
    E.5 End points
    E.5.1Primary end point(s)
    Best corrected visual acuity (BCVA)
    Bestkorrigierter Visus
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 4 weeks for a total of 13 month
    aller 4 Wochen für 13 Monate
    E.5.2Secondary end point(s)
    - Central macular thickness measured by SD-OCT
    - Number of treatments with Lucentis
    - Zentrale Makuladicke bestimmt durch SD-OCT
    - Anzahl der notwendigen Behandlungen mit Lucentis
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 4 weeks for a total of 13 month
    aller 4 Wochen für 13 Monate
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard therapy with Lucentis is compared to combination therapy with laser
    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
    clean data base
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    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)
    none
    keine
    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 Decision2014-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
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