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    Summary
    EudraCT Number:2016-004488-38
    Sponsor's Protocol Code Number:ILV-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-18
    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 - BfArM
    A.2EudraCT number2016-004488-38
    A.3Full title of the trial
    Iluvit – An investigator initiated monocentric pilot study to investigate inflammation parameters and growth factors in the vitreous during a cortisone long-term therapy with Iluvien® in patients with chronic diabetic macular edema
    Iluvit - Eine Investigator-initiierte, monozentrische Pilotstudie zur Untersuchung von Entzündungs- und Wachstumsparametern im Glaskörpermaterial während einer Kortison-Langzeittherapie (Iluvien®) bei Patienten mit chronischem diabetischem Makulaödem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the influence of the corticosteroid agent Iluvien on inflammation and growth factors in the eye of patients suffering from diabetic-related retina damage with swelling of the centre of the retina
    Untersuchung des Einflusses des Kortikosteroid-Medikamentes Iluvien auf die
    Entzündungs- und Wachstumsfaktoren im Auge von Patienten, die unter
    einer Diabetes-bedingten Netzhautschädigung mit Schwellung der Netzhautmitte leiden
    A.3.2Name or abbreviated title of the trial where available
    Iluvit
    Iluvit
    A.4.1Sponsor's protocol code numberILV-001
    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 SponsorJ. W. Goethe University, represented by dean of the medical faculty
    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 supportAlimera Sciences Ophthalmologie GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Johann Wolfgang Goethe-Universität Frankfurt Klinik für Augenheilkunde
    B.5.2Functional name of contact pointProf. Dr. Frank Koch
    B.5.3 Address:
    B.5.3.1Street AddressTheodor - Stern - Kai 7 / Haus 7C
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number+496963015649
    B.5.5Fax number+496963015621
    B.5.6E-mailfkoch1@icloud.com
    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 ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
    D.2.1.1.2Name of the Marketing Authorisation holderAlimera Sciences 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 Intravitreal implant in applicator
    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 INNFLUOCINOLONE ACETONIDE
    D.3.9.1CAS number 67-73-2
    D.3.9.4EV Substance CodeSUB07714MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number171 to 209
    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
    Diabetic related Macula edema
    Diabetisches Makulaödem
    E.1.1.1Medical condition in easily understood language
    Diabetic-related retina damage with swelling of retina centre
    Diabetes-bedingte Netzhautschädigung mit Schwellung der Netzhautmitte
    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
    The primary objective of this study is to investigate the impact of Iluvien® therapy on the inflammation factor IL-6 as both, IL-6 and growth factors, have a critical role in the development of DME. Later on and based on the results of this pilot study, the impact of Iluvien® therapy on the inflammation factor IL-6 will perhaps be analysed in a larger patient group treated over a longer period of time.
    Primäres Ziel dieser Studie ist es, zu zeigen, ob eine intravitreale Iluvien® - Therapie einen Einfluss auf den Entzündungsfaktor IL-6 besitzt, welcher, im Zusammenspiel mit Wachstumsfaktoren, maßgeblich an der Ausbildung des diabetischen Makulaödems beteiligt ist. In einer möglichen Folgestudie soll der Einfluss der Iluvien® - Therapie auf IL-6 dann mit einer größeren Stichprobe über einen längeren Zeitraum untersucht werden.
    E.2.2Secondary objectives of the trial
    The impact of Iluvien® therapy on the following factors will be investigated as secondary objectives: VEGF, IL-1b, IL-8, IP-10,
    ICAM-1, PDGF, MCP-1, PGF, PEDF
    Sekundäres Ziel dieser Studie ist es, zu zeigen, ob die Iluvien® -Therapie einen Einfluss auf folgende Faktoren hat: VEGF, IL-1b, IL-8, IP-10,
    ICAM-1, PDGF, MCP-1, PGF, PEDF
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The patient has at least 18 years of age
    - Willingness and ability to give written informed consent
    - Fertile men and women of childbearing potential agree to use effective contraception (Pearl-Index <1) during study treatment
    - Diabetes mellitus type I or type II
    - Diabetic retinopathy and diabetic macular edema
    - Before study start planned implantation of Iluvien® in patients with the indication for the therapy with Iluvien® according to summary of product characteristics (SmPC)
    - Central macular thickness ≥250 µm
    - Best corrected visual acuity (BCVA) between 19 and 78 characters (ETDRS) corresponds with Snellen Equivalent 20/ 400 – 20/ 30
    - Mindestalter von 18 Jahren
    - Bereitschaft und Fähigkeit eine Einverständniserklärung zu unterzeichnen
    - Fruchtbare Männer und gebärfähige Frauen müssen zustimmen, während der Studienbehandlung eine höchst effektive Verhütungsmethode (Pearl - Index < 1) anzuwenden
    - Diabetes mellitus Typ 1 oder Typ 2
    - Diabetische Retinopathie und diabetisches Makulaödem
    - Vor Studienbeginn geplante Implantation von Iluvien® bei
    Patienten mit Indikation zur Iluvien® - Therapie gemäß der Fachinformation
    - Zentrale Retinadicke ≥250 µm
    - Score zur bestkorrigierten VA (BCVA) zwischen 19 und 78 Buchstaben (ETDRS) korrespondiert mit Snellen Äquivalent 20/ 400 - 20/ 30
    E.4Principal exclusion criteria
    Criteria concerning study eye:
    • Vitreous body completely removed (3-Port vitrectomy)
    • Previous pharmacological treatment with anti-angiogenic agent (e.g. Ranibizumab, Bevacizumab), cppV with drug treatment or prior laser coagulation within 90 days before screening
    • Previous pharmacological treatment with long-acting corticosteroids (periocular or intraocular) within 90 days before screening
    • Cataract surgery within 90 days before screening
    • Application of a yttrium-aluminium-garnet laser within 90 days before screening
    • Intraocular surgery within 90 days before screening
    • Ocular disease (e.g. inflammation, infection, virus-related disorders of cornea and conjunctiva) at screening
    • Clinical significant glaucoma
    General exclusion criteria:
    • The patient is pregnant or is nursing before and during study treatment
    • Contraindication for application of Iluvien® according to SmPC
    • Uncontrolled hypertension (RR > 160/90 mmHg)
    • Autoimmune disease
    • Poorly controlled diabetes mellitus (HbA1c < 10%)
    • Participation in other clinical trials within 30 days before screening
    • History of drug, alcohol, or chemical substances abuse within 180 days before screening
    • Any condition that is contradictory to a participation in this trial according to the investigator’s opinion
    Das Studienauge betreffend:
    • Komplette Glaskörperentfernung (3 - Port Vitrektomie)
    • Pharmakologische Behandlung mit einem anti-angiogenen Wirkstoff (z.B. Ranibizumab, Bevacizumab), cppV mit Medikamenteneingabe oder Laserkoagulation innerhalb der letzten 90 Tage vor Screening
    • Pharmakologische Behandlung mit einem langwirksamen Kortikosteroid (periokular oder intraokular) innerhalb der letzten 90 Tage vor Screening
    • Katarakt-OP innerhalb der letzten 90 Tage vor Screening
    • Anwendung eines Yttrium - Aluminium - Granat Lasers innerhalb der letzten 90 Tage vor Screening
    • Intraokulare OP innerhalb der letzten 90 Tage vor Screening
    • Erkrankung des Auges (Entzündung, Infektion, Viruserkrankung der Hornhaut oder Bindehaut) zum Zeitpunkt des Screenings
    • Klinisch signifikantes Glaukom
    Generelle Ausschlusskriterien:
    • Patient ist schwanger oder stillt vor und während des Studienverlaufes
    • Vorliegen einer Kontraindikation für die Anwendung von Iluvien® gemäß Fachinformation
    • Unkontrollierter Bluthochdruck (RR > 160/ 90 mmHg)
    • Autoimmunerkrankung
    • Schlecht eingestellter Diabetes mellitus (HbA1c < 10 %)
    • Teilnahme an einer klinischen Prüfung innerhalb der letzten
    30 Tage vor Screening
    • Drogen- , Alkohol- oder Medikamentenmissbrauch innerhalb von 180 Tagen vor Screening
    • Jeder Zustand, der nach Meinung des Prüfarztes einer Studienteilnahme widerspricht
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the determination of IL-6 concentration in the posterior vitreous at the following time points:
    - T0: Start of treatment (Iluvien® implantation)
    - T2: 1 month after Iluvien® implantation
    - T4: 6 month after Iluvien® implantation
    Der primäre Endpunkt der Studie ist die Bestimmung der IL-6 Konzentration im hinteren Kompartiment des Glaskörpers zu folgenden Zeitpunkten:
    - T0: Behandlungsbeginn (Iluvien® - Implantation)
    - T2: 1 Monat nach Iluvien® - Implantation
    - T4: 6 Monate nach Iluvien® - Implantation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the end point can be performed after the last study visit (T4) has been completed and the last IL-6 concentration at T4 has been measured
    Die Bestimmung des Endpunktes erfolgt, sobald die letzte Studienvisite (T4) durchgeführt wurde und die letzte IL-6 Konzentration zu T4 bestimmt wurde
    E.5.2Secondary end point(s)
    Determination of concentrations of following factors: VEGF, IL-1b, IL-8, IP-10, ICAM-1, PDGF, MCP-1, PGF, PEDF concentration in the posterior vitreous at the following time points:
    - T0: Start of treatment (Iluvien® implantation)
    - T2: 1 month after Iluvien® implantation
    - T4: 6 month after Iluvien® implantation
    Bestimmung der Konzentrationen folgender Faktoren im hinteren Kompartiment des Glaskörpers: VEGF, IL-1b, IL-8, IP-10, ICAM-1, PDGF, MCP-1, PGF und PEDF zu den Zeitpunkten:
    - T0: Behandlungsbeginn (Iluvien®-Implantation)
    - T2: 1 Monat nach Iluvien®-Implantation
    - T4: 6 Monate nach Iluvien® - Implantation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the end point can be performed after the last study visit (T4) has been completed and the last concentrations at T4 have been measured
    Die Bestimmung des Endpunktes erfolgt, sobald die letzte Studienvisite (T4) durchgeführt wurde und die letzten Konzentrationen zu T4 bestimmt wurden
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    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
    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 Decision2017-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-04
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