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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2020-000681-42
    Sponsor's Protocol Code Number:CoRaLa_II
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-04-29
    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 number2020-000681-42
    A.3Full title of the trial
    Long-term need of ranibizumab injections with or without early targeted peripheral laser photocoagulation for treatment of macular edema due to central retinal vein occlusion
    Langzeitbedarf von Ranibizumab-Injektionen mit oder ohne frühzeitige gezielte peri-phere Laser-Photokoagulation zur Behandlung des Makulaödems infolge eines Zentralvenenverschlusses
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term need of the drug ranibizumab applied as injection into the eye with or without early targeted peripheral laser photocoagulation of the retina for treatment of macular edema due to central retinal vein occlusion
    Langzeitbedarf des Medikaments Ranibizumab als Injektion ins Auge mit oder ohne frühzeitige gezielte periphere Laser-Photokoagulation der Netzhaut zur Behandlung des Makulaödems infolge eines Zentralvenenverschlusses
    A.3.2Name or abbreviated title of the trial where available
    Combination of Ranibizumab and targeted Laser
    Kombinaiton von Ranibizumab und Laserphotokoagulation
    A.4.1Sponsor's protocol code numberCoRaLa_II
    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 SponsorJustus-Liebig University Gießen
    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 supportBMBF
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJustus-Liebig-Universität
    B.5.2Functional name of contact pointDepartment of Ophthalmology
    B.5.3 Address:
    B.5.3.1Street AddressFriedrichstraße 18
    B.5.3.2Town/ cityGießen
    B.5.3.3Post code35392
    B.5.3.4CountryGermany
    B.5.4Telephone number004964198543801
    B.5.5Fax number004964198543809
    B.5.6E-mailMatus.Rehak@uk-gm.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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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.3.1Product nameRanibizumab
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeSUB22314
    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 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
    Macular edema due to central retinal vein occlusion
    Makulaödem infolge eines Zentralvenenverschlusses
    E.1.1.1Medical condition in easily understood language
    Macular edema due to central retinal vein occlusion
    Makulaödem infolge eines Zentralvenenverschlusses der Netzhaut
    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 10054467
    E.1.2Term Macular edema
    E.1.2System Organ Class 100000004853
    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 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate whether or not the duration of guideline-conform periodic ranibizumab injections may be shortened or even be successfully terminated in patient with macular edema due to central retinal vein occlusion if early targeted peripheral laser photocoagulation is applied in parallel.
    Das primäre Ziel ist die Beurteilung, ob die Dauer der Leitlinien-konformen periodischen Ranibizumab-Injektionen bei Patienten mit Makulaödem aufgrund eines Zentralvenenverschlusses verkürzt oder sogar erfolgreich beendet werden kann, wenn parallel dazu eine frühzeitige, gezielte periphere Laser-Photokoagulation durchgeführt wird.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the visual acuity during and after the course of intervention, quality of life associated aspects and possible problems which might possibly be associated with the trial’s Intervention.
    Sekundäre Ziele sind die Untersuchung der Sehschärfe während und nach der Behandlungszeit, Auswirkungen auf die Lebensqualität und die Erfassung von möglichen Problemen, die möglicherweise in Zusammenhang mit der Studientherapie stehen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of macular edema due to central retinal vein occlusion foveal thickness >250 μm (measured by optical coherence tomography (OCT))
    2. Age  18 years
    3. Written informed consent of the patient
    4. Best corrected visual acuity (BCVA) score in the study eye between 24 letters (20/320) and 78 letters (20/25) measured in ETDRS chart
    5. History of central retinal vein occlusion (CRVO) no longer than 6 months
    6. Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas documented in ultra wide-field fluorescein angiography
    7. Ability and willingness to attend all scheduled visits and assessments
    1. Gesichertes Makulaödem als Folge eines Zentralvenenverschlusses. Zentrale Netzhautdicke > 250 μm (mittels OCT bestimmt).
    2. Alter ≥ 18 Jahre
    3. Schriftliche Zustimmung der Teilnahme an der Studie
    4. Sehschärfe am Studienauge zwischen 24 Buchstaben (20/320) und 78 Buchstaben (20/25) – gemessen mittels ETDRS Prüftafel
    5. Zentralvenenverschluss nicht älter als 6 Monate
    6. Angiographisch gesicherte periphere ischämische Netzhautareale mit einer Größe von > 5 Papillenflächen (mittels FAG)
    7. Bereitschaft und Fähigkeit die vorgeschriebenen Studienvisiten einzuhalten
    E.4Principal exclusion criteria
    1. CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone larger than 2 optic disc diameters
    2. Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
    3. History of idiopathic central serous chorioretinopathy
    4. Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
    5. An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
    6. Aphakia in the study eye
    7. Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
    8. Intraocular or periocular injection of steroids in the study eye prior to study entry
    9. Previous use of an anti-VEGF drug in the study eye
    10. Cataract surgery or any other intraocular surgery in the study eye within 3 months prior to study entry
    11. Uncontrolled glaucoma (defined as intraocular pressure ≥ 30 mmHg despite treatment with maximal anti-glaucoma medications)
    12. History of stroke, myocardial infarction, transient ischemic attacks within 3 months prior to the study
    13. Pregnancy (positive urine pregnancy test) or lactation
    14. The presence of active malignancy, including lymphoproliferative disorders.
    15. History of allergy to fluorescein or a component of the ranibizumab formulation
    16. Active intraocular infection
    17. Participation in another simultaneous interventional medical investigation or trial
    18. Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial.
    1. Ischämischer Zentralvenenverschluss definiert durch Vorhandensein von ischämischen Netzhautareale in der Makula größer als 2 Papillenflächen
    2. Makulaödem als Folge anderer Ursache als Zentralvenenverschluss (z.B. diabetische Retinopathie, Uveitis, altersabhängige Makuladegeneration, Irvine-Gass-Syndrom usw.)
    3. Vorangegangene idiopathische zentrale seröse Netzhautschädigung
    4. Bestehende Erkrankung der vitreoretinalen Grenzschicht (z.B. vitreomakuläre Traktionssyndrom, epiretinale Membran) festgestellt in klinischen Untersuchungen oder OCT
    5. Ein Auge, für das in der Beurteilung des Prüfers kein Vorteil durch die Behandlung des Makulaödems zu erwarten ist. Z.B. foveale Atrophie, dichte Pigmentveränderungen oder dichte subfoveale harte Exsudate
    6. Aphakie im Studienauge
    7. Laserphotokoagulation der Netzhautperipherie oder fokale zentrale Laserphotokoagulation im Studienauge vor Studieneinschluss
    8. Intra- oder periokuläre Steroidapplikation am Studienauge vor Studieneinschluss
    9. Vorherige Anwendung von VEGF-Hemmer am Studienauge
    10. Kataraktoperation oder andere intraokulare Operationen am Studienauge innerhalb von 3 Monaten vor Studieneinschluss
    11. Unkontrolliertes Glaukom (definiert als Augendruck ≥ 30 mmHg) trotz maximaler Glaukom-Behandlung
    12. Vorausgegangener Schlaganfall, Herzinfarkt, transitorische ischämische Attacken innerhalb von 3 Monaten vor Studieneinschluss
    13. Schwangere (mit positivem Urin-Schwangerschaftstest) oder stillende Frauen
    14. Bekannte aktive maligne Erkrankung, einschließlich lymphoproliferative Erkrankungen.
    15. Bekannte Allergie auf Fluoreszein oder Komponenten der Ranibizumab-Formulierung
    16. Aktive intraokuläre Infektion
    17. Aktuelle Teilnahme an anderen interventionellen klinischen Prüfungen
    18. Frauen im gebärfähigen Alter ohne hochwirksame Empfängnisverhütung (z.B. Implantate, Spritzen, kombinierte orale Kontrazeptiva, intrauterine devices – Spiralen etc., vasektomierter Partner) während der Studienteilnahme
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint is the time to treatment success, defined as time from randomisation until the date of last criteria-based intravitreal injection in case that thereafter a treatment-free period for (at least) 6 months was observed.
    Der primäre Endpunkt ist die Zeit bis zum Behandlungserfolg, definiert als die Zeit ab Randomisation bis zur letzten kriterienbasiert vorgenommenen Injektion, vorausgesetzt, der Patient wies anschließend mindestens 6 Monate lang keinen erneuten Re-Injektionsbedarf (gemäß den Behandlungsrichtlinien) auf.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each mandatory visit (Monthly between Month 1 to Month 12 and then at Months 16, 20, 24 and 29) at the latest at Months 29
    Zu jeder obligatorischen Visite (monatlich zwischen Monat 1 und 12 und dann zu den Monaten 16, 20, 24 und 29) spätestens zu Monat 29.
    E.5.2Secondary end point(s)
    Secondary endpoints (sEP) are:
    • the best corrected visual acuity (BCVA)
    • central subfield thickness (CST)
    • the number of ranibizumab injections required until treatment success and up to the end of observation.
    • the proportion of subjects developing neovascularization(s) over total observation period.
    Sekundäre Ziele sind:
    1. die bestkorrigierte Sehschärfe
    2. die zentralen Netzhautdicke, gemessen mit optischer Kohärenztomografie
    3. die Anzahl an benötigten Ranibizumab-Injektionen bis zum Therapieerfolg, sowie bis Studienende
    4. Anteil der Patienten mit Entwicklung von neovaskulären Komplikationen über die gesamte Beobachtungszeit hinweg
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each mandatory visit (Monthly between Month 1 to Month 12 and then at Months 16, 20, 24 and 29) at the latest at Months 29
    Zu jeder obligatorischen Visite (monatlich zwischen Monat 1 und 12 und dann zu den Monaten 16, 20, 24 und 29) spätestens zu Monat 29.
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Der Kontrollarm erhält das AM - der experimentelle Arm erhält das AM und Laserkoagulation
    The controll arm receives the IMP - the experimental arm receives the IMP and lasercoagulation
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Yes
    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
    Letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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 be treated at the investigator´s discretion.
    Die Patienten werden gemäß der Einschätzung des Prüfers
    weiterbehandelt.
    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 Decision2020-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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