Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004656-38
    Sponsor's Protocol Code Number:CRF002EVA
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-11-18
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-004656-38
    A.3Full title of the trial
    Assessment of the suitability of serum VEGF level as diagnostic factor in macula edema caused by retinal or central retinal vein occlusion under therapy with Lucentis® (ranibizumab)
    Bewertung der Eignung des Serum VEGF Spiegels als diagnostischer Faktor bei einem Makulaödem bedingt durch einen Venenastverschluss/ Zentralvenenverschluss unter Therapie mit Lucentis® (Ranibizumab)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the suitability of serum VEGF level as diagnostic factor in macula edema under therapy with Lucentis® (ranibizumab)
    Bewertung der Eignung des Serum VEGF Spiegels als diagnostischer Faktor bei einem Makulaödem unter Therapie mit Lucentis® (Ranibizumab)
    A.4.1Sponsor's protocol code numberCRF002EVA
    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 SponsorProf. Dr. Karl-Heinz Emmerich
    B.1.3.4CountryGermany
    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 Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinisches Monitoring
    B.5.2Functional name of contact pointKerstin Michalek
    B.5.3 Address:
    B.5.3.1Street AddressElektronstr. 2
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code65933
    B.5.3.4CountryGermany
    B.5.4Telephone number496997787669
    B.5.6E-mailk-michalek@t-online.de
    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 Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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
    Central retinal vein occlusion
    Retinal vein occlusion
    E.1.1.1Medical condition in easily understood language
    Occlusion of a vein of the retina
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007972
    E.1.2Term Central retinal vein occlusion
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10038907
    E.1.2Term Retinal vein occlusion
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the suitability of serum VEGF level for the diagnostic differentiation between therapy responders (no macula edema in OCT) and therapy non-responders (persistence of macula edema, or reoccurrence of macula edema or increase of the macula edema at V2 of more than 50 micrometers) 12 weeks after start of the therapy.
    Bewertung der Eignung des Serum VEGF-Wertes zur diagnostischen Unterscheidung von Therapie-Respondern (kein Makulaödem-Nachweis im OCT) und Therapie-Non-Respondern (Persistenz des Makulaödems, Wieder-Auftreten eines Makulaödems oder Erhöhung (≥ 50 Mikrometer) des bei V2 (Baseline) bestehenden Makulaödems) 12 Wochen nach Therapiebeginn.
    E.2.2Secondary objectives of the trial
    - Time until first occurrence of a recurrent macula edema in the subgroup of patients with reoccurrence of macula edema or increase (more than 50 micrometer) of the macula edema present at baseline (V2)
    - Course of VEGF level and change in comparison with baseline (Visit 2) over the entire study duration in the subgroups
    - Course
    - Zeit bis zum ersten Auftreten eines Makula-Rezidivödems für die Subgruppe der Patienten mit Wieder-Auftreten eines Makulaödems oder Erhöhung (≥ 50 Mikrometer) des bei V2 (Baseline) bestehenden Makulaödems
    - Verlauf des VEGF-Spiegels und der Änderung im Vergleich zur Baseline-Visite V2 über die gesamte Studiendauer innerhalb der Subgruppen
    - Verlauf der Sehschärfe und der Änderung im Vergleich zur Baseline-Visite über die gesamte Studiendauer innerhalb der Subgruppen
    - Verlauf der Makuladicke und der Änderung der Makuladicke über die gesamte Studiendauer innerhalb der Subgruppen
    - Vaskularisation im Kammerwinkel (ja/nein) im Verlauf der Studie innerhalb der Subgruppen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed and dated Informed Consent prior to conduct of any study-related procedure
    - Adult patient aged 18 years or more with the diagnosis of a decrease in visual acuity due to macula edema as a consequence of central retinal or retinal vein occlusion maximum 12 months prior to screening
    - Central retinal thickness (CRT) > 250 µm
    - Clear breaking media, possibility for good mydriasis and good cooperation of the patient in case of fundus photography
    - Vorliegen einer vom Patienten und dem aufklärenden Arzt unterschriebene und eigenhändig datierte Einwilligungserklärung vor Beginn einer jeglichen studienbezogenen Maßnahme
    - Erwachsene Patienten ≥18 Jahre mit der Diagnose eines Visusabfalls bei Makulaödem in Folge eines Venenastverschlusses oder Zentralvenenverschlusses maximal 12 Monate vor dem Screening
    - Zentrale Netzhautdicke (CRT) > 250 µm
    - Klare brechende Medien, Möglichkeit der guten Mydriasis und gute Mitarbeit des Patienten für eine Fundusfotographie
    E.4Principal exclusion criteria
    - Central retinal thickness ≤ 250 µm
    - Previous episode(s) of retinal vein occlusion at the study eye
    - Active neovascularisation
    - Aphakia of study eye (pseudo-aphake eyes are allowed)
    - History of thrombotic or embolic disease
    - Every history of a apoplectic insult or a transitory ischemic attack (TIA)
    - Ocular or systemic anti-VEGF-treatment in the three months prior to screening
    - History of pars plana vitrectomy
    - Combined arterio-venuous occlusion
    - Intraocular intervention within the 2 months prior to screening or planned intraocular intervention in the 12 months after screening
    - Known vitreoretinal diseases,
    - Intraocular pressure ≥ 30 mm or uncontrolled glaucoma
    - Every active infection at one of the two eyes
    - Every ocular disease which in the opinion of the investigator would distort the study results
    - Every relevant ocular disease which could affect the increase of the intraocular VEGF level
    - Every relevant systemic disease which could potentially lead to an increase of the systemic VEGF level
    - Known hyper sensivity or allergy to the study medication or any medication needed for diagnosis/therapy
    - Diseases or conditions which in the opinion of the investigator exclude a subject's participation in the trial
    - Participation in another clinical or non-intverventional study
    - Zentrale Netzhautdicke ≤ 250 µm
    - Vorherige Episode(n) eines retinalen Gefäßverschlusses am Studienauge
    - Aktive Neovaskularisation
    - Aphakie im Studienauge (pseudophake Augen sind erlaubt)
    - Vorgeschichte einer thrombotischen oder embolischen Erkrankung
    - Jede Vorgeschichte eines apoplektischen Insults oder einer transitorischen ischämischen Attacke (TIA)
    - Okuläre oder systemische Anti-VEGF-Behandlung innerhalb von 3 Monaten vor dem Screening
    - Vorgeschichte einer Pars Plana Vitrektomie
    - Kombinierte arteriovenöse Okklusion
    - Intraokulare Eingriffe innerhalb von 2 Monaten vor dem Screening oder geplante intraokulare Eingriffe innerhalb der nächsten 12 Monate nach Screening
    - Bekannte vitreoretinale Erkrankung, z. B. vitreomakuläre Traktion, epiretinale Membranen
    - Intraokular Druck ≥ 30 mm Hg oder unkontrolliertes Glaukom
    - Jede aktive Infektion an einem der beiden Augen
    - Jede okuläre Erkrankung, die nach der Meinung des Prüfers/Arztes der Prüfgruppe das Studienergebnis verfälschen würde (z. B. Uveitis, jede andere entzündliche Erkrankung, Neovaskularisationsglaukom, Irivine-Gass-Syndrom, retinale rhegmatogene Netzhauterkrankung)
    - Jede relevante okuläre Erkrankung, die das Ansteigen des intraokularen VEGF-Spiegels beeinflussen könnte (z. B. Uveitis, Neovaskularisationsglaukom, neovaskuläre AMD, diabetische Retinopathie, diabetische Makulopathie oder Ischämiesyndrom)
    - Jede relevante systemische Erkrankung, die eventuell den systemischen VEGF-Spiegel ansteigen lassen könnte (z. B. aktive Malignitäten, Vorgeschichte einer behandelten Malignität)
    - Bekannte Hypersensivitäten oder Allergien auf das Studienmedikament oder Medikamente, die zur Untersuchung/Therapie benötigt werden
    - Erkrankungen oder Umstände, die der Meinung des Prüfarztes eine Studienteilnahme ausschließen (z. B. chronischer Alkoholismus, Drogenabhängigkeit)
    - Teilnahme an einer anderen klinischen Prüfung oder nicht-interventionellen Studie
    E.5 End points
    E.5.1Primary end point(s)
    Serum VEGF level
    Serum VEGF-Wert
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after start of study therapy
    12 Wochen nach Therapiebeginn
    E.5.2Secondary end point(s)
    - Time until occurrence of a recurrent macula edema as calculated from baseline (Visit 2) until reoccurrence of macula edema (upon improvement) or until first increase of at least 50 micrometers as compared withe baseline measurement based on OCT
    - VEGF at time of investigation
    - Visual acuity at time of investigation
    - Macula thickness at time of investigation
    - Vascularisation at time of investigation
    - Zeit bis zum ersten Auftreten eines Makulaödem-Rezidivs berechnet von Baseline-Visite (V2) bis zum Wieder-Auftreten eines Makulaödems (nach Besserung) oder bis zur erstmaligen Erhöhung um mindestens 50 μm im Vergleich zur Messung bei Visite 2 anhand der OCT-Messung
    - VEGF zu den einzelnen Untersuchungszeitpunkten
    - Sehschärfe zu den einzelnen Untersuchungszeitpunkten
    - Makuladicke zu den einzelnen Untersuchungszeitpunkten
    - Vaskularisation zu den einzelnen Untersuchungszeitpunkten
    E.5.2.1Timepoint(s) of evaluation of this end point
    At time of investigation
    zu den einzelnen Untersuchungszeitpunkten
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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) 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 Yes
    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 = 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 years3
    E.8.9.1In the Member State concerned months9
    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: 15
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-11-18. Yes
    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 state30
    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 of that condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 16:36:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA