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    Summary
    EudraCT Number:2011-005631-20
    Sponsor's Protocol Code Number:206207-024
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005631-20
    A.3Full title of the trial
    A Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of 700 μg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) to Ranibizumab in Patients With Diabetic Macular Edema
    Studio multicentrico, in aperto, randomizzato che confronta l'efficacia e la sicurezza del sistema di rilascio di desametasone 700 μg nel segmento posteriore (DEX PS DDS) con quelle del ranibizumab in pazienti con edema maculare diabetico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of OZURDEX versus Lucentis in the treatment of Diabetic Macular Edema.
    Confronto dell'efficacia e sicurezza di Ozurdex e Lucentis nel trattamento dell'edema maculare diabetico
    A.3.2Name or abbreviated title of the trial where available
    DEX PS DDS vs Ranibizumab in patients with DME
    DEX PS DDS vs Ranibizumab in pazienti con EMD
    A.4.1Sponsor's protocol code number206207-024
    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 SponsorALLERGAN LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL71YL
    B.5.3.4CountryItaly
    B.5.4Telephone number+44 1628 494444
    B.5.5Fax number+44 1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 OZURDEX*IMP INTRAVIT 700MCG+AP
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Ophthalmic insert
    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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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.IMP: 2
    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*INIET 1FL 0,23ML 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for 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
    Diabetic Macular Edema
    Edema Maculare Diabetico
    E.1.1.1Medical condition in easily understood language
    Diabetic Macular Edema
    Edema Maculare Diabetico
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    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
    To evaluate whether treatment with 700 μg DEX PS DDS every 5 months provides a similar treatment effect on average change of best-corrected visual acuity (BCVA) as ranibizumab administered as per its European Summary of Product Characteristics (SmPC) in patients with DME
    Valutare se il trattamento con DEX PS DDS 700 μg ogni 5 mesi offre un effetto di trattamento sulla variazione media della migliore acuità visiva corretta (BCVA, best-corrected visual acuity) simile al ranibizumab somministrato conformemente al Riassunto delle caratteristiche del prodotto (RCP) europeo in pazienti con EMD
    E.2.2Secondary objectives of the trial
    To evaluate the effects of 700 μg DEX PS DDS on central retinalthickness (CRT) and other anatomical changes relative to ranibizumab 0.5 mg in patients with DME. To evaluate the effects of 700 μg DEX PS DDS on patient-reported outcomes (PROs) relative to ranibizumab 0.5 mg in patients with DME. To evaluate the safety of 700 μg DEX PS DDS relative to ranibizumab 0.5 mg in patients with DME. To evaluate the effect of 700 μg DEX PS DDS on BCVA average change in pseudophakic subgroup of patients relative to ranibizumab 0.5 mg in patients with DME
    Valutare gli effetti di DEX PS DDS 700 μg sullo spessore retinico centrale (SRC) e altre variazioni anatomiche rispetto al ranibizumab 0,5 mg in pazienti con EMD Valutare gli effetti di DEX PS DDS 700 μg sui risultati riportati dai pazienti (PRO,patient-reported outcomes) rispetto al ranibizumab 0,5 mg in pazienti con EMD Valutare la sicurezza di DEX PS DDS 700 μg rispetto al ranibizumab 0,5 mg in pazienti con EMD Valutare l'effetto di DEX PS DDS 700 μg sulla variazione media della BCVA in un sottogruppo di pazienti pseudofachici rispetto al ranibizumab 0,5 mg in pazienti con EMD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female, at least 18 years of age. Diagnosis of diabetes mellitus (type 1 or type 2) as defined by the World Health Organization/International Diabetes Federation (Report ofa WHO/IDF consultation, 2006) - Fasting plasma glucose level ≥ 7.0 mmol/L (126 mg/dL) or Plasma glucose ≥ 11.1 mmol/L (200 mg/dL) 2 hours after a 75 g oral glucose load as in a glucose tolerance test. Presence of macular edema associated with diabetic retinopathy defined as macular thickening by optical coherence tomography (OCT) assessed by the investigator in the study eye with the following characteristics: - involving the center of the macula (fovea) - VA decrease attributable to macular edema BCVA score ≥ 34 and ≤ 70 letters (approximately 20/200 to 20/40 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method in the study eye at the screening visit. Study eye mean retinal thickness by spectral domain OCT in the 1 mm central macular subfield of ≥ 300 μm with Spectralis (Heidelberg) or 275 μm with Cirrus (Zeiss) as determined by the investigator at the screening visit. (Both Eyes) Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures. Written informed consent has been obtained in accordance with state and country privacy requirements, where applicable.
    Soggetti di sesso maschile o femminile di età pari o superiore a 18 anni Diagnosi di diabete mellito (tipo 1 o tipo 2) come definito dall'OMS/ Federazione Internazionale del Diabete Punteggio BCVA ≥ 34 e ≤ 70 lettere (da 20/200 a 20/40 circa della scala Snellen) utilizzando il metodo di studio per il trattamento precoce della retinopatia diabetica (ETDRS, Early Treatment Diabetic Retinopathy Study) nell'occhio dello studio alla visita di screening Presenza di edema maculare associato a retinopatia diabetica, definito come ispessimento maculare valutato tramite OCT dallo sperimentatore nell'occhio dello studio con tutte le seguenti caratteristiche: - interessamento del centro della macula (fovea) - diminuzione dell'acuità visiva (AV) attribuibile a edema maculare Spessore retinico medio dell'occhio dello studio tramite OCT a dominio spettrale nel sottocampo maculare centrale di 1 mm ≥ 300 μm con Spectralis (Heidelberg) o 275 μm con Cirrus (Zeiss), secondo quanto rilevato dallo sperimentatore alla visita di screening
    E.4Principal exclusion criteria
    Systemic conditions or treatments; History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, might affect the interpretation of study results or render the patient at high risk from treatment complications. HbA1c (glycated hemoglobin) >12% at baseline. Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to baseline or anticipated change of anti-diabetic medications during the 1-year study participation. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to baseline or anticipated need for hemodialysis or peritoneal dialysis at any time during the study or adjusted glomerular filtration rate < 50 mL/min. Use of systemic (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) corticosteroids within 1 month prior to screening. Uncontrolled systemic diseaseOcular concomitant conditions/disease Any current or history of ocular disease in the study eye, other than DME that in the opinion of the investigator may confound assessment of the macula or affect central vision (for example: exudative age-related macular degeneration [AMD], geographic atrophy, macular edema due to retinal vein occlusion, uveitis, angioid streaks, histoplasmosis, active or inactive cytomegalovirus, pathological myopia, retinal detachment, macular traction, macular fibrosis or scarring, macular hole, significant cataract). Increased intraocular pressure (IOP ≥ 22 mmHg) at screening or day 1, or diagnosis of glaucoma. Any active ocular inflammation or ocular infection (ie, bacterial, viral, parasitic, or fungal) in either eye at the screening visit. Aphakia in the study eye or break in the posterior capsule in the study eye, unless it is a small break resulted from a YAG laser posterior capsulotomy in association with prior posterior intraocular lens implantation Anticipated need for ocular surgery in the study eye during the 1- year study participation. Active proliferative diabetic retinopathy and/or rubeosis. BCVA score < 34 letters in fellow eye. Ocular treatment Laser photocoagulation to the study eye within 3 months prior to screening. Use of anti-VEGF treatment in study eye within 3 months prior to screening or use of systemic anti-VEGF within 6 months prior to screening Use of intravitreal triamcinolone within 6 months prior to screening. Use of topical intraocular, intravitreal (except triamcinolone, see above) or periocular corticosteroids within 3 months prior to screening in the study eye or ocular conditions in the study eye that require chronic concomitant therapy with topical, local ocular or systemically administered corticosteroids. History of use of DEX PS DDS within 9 months prior to screening. History of cataract surgery within the 3 months prior to baseline. History of vitrectomy. History of incisional glaucoma surgery. Known allergy, hypersensitivity or contraindication to the study medications, its components, fluorescein or povidone iodine. Compliance / administrative. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception. Current enrollment in an investigational drug or device study or participation in such a study within the 30 days prior to day 1 Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
    Malattia sistemica non controllata;HbA1c (emoglobina glicata) &gt;12% al basale; Qualunque patologia oculare in atto o precedente nell'occhio dello studio, diversa da EMD, che a discrezione dello sperimentatore possa confondere la valutazione della macula o influenzare la visione centrale (ad esempio: degenerazione maculare essudativa correlata all'età [AMD, age-related macular degeneration], atrofia geografica, edema maculare dovuto a occlusione della vena retinica, uveite, strie angioidi, istoplasmosi, citomegalovirus attivo o inattivo, miopia patologica, distacco retinico, trazione maculare, fibrosi maculare o cicatrizzazione, foro maculare, cataratta significativa) Aumento della pressione intraoculare (PIO ≥ 22 mmHg) allo screening o al giorno 1 oppure diagnosi di glaucome Fotocoagulazione con laser dell'occhio dello studio nei 3 mesi precedenti lo screening Triamcinolone intravitreale nei 6 mesi precedenti lo screening Uso di corticosteroidi topici intraoculari, intravitreali (tranne il triamcinolone, vedere sopra) o perioculari nei 3 mesi precedenti lo screening nell'occhio dello studio o condizioni oculari a carico dell'occhio dello studio che necessitano di terapia cronica concomitante con corticosteroidi per uso topico, locale oculare o sistemico Anamnesi di uso di DEX PS DDS nei 9 mesi precedenti lo screening Uso di trattamento anti-VEGF (vascular endothelial growth factor [fattore di crescita endoteliale vascolare]) nell'occhio dello studio nei 3 mesi precedenti lo screening o uso di anti-VEGF sistemico nei 6 mesi precedenti lo screening; Uso di corticosteroidi sistemici (es. orale, endovenoso, intramuscolare, epidurale, rettale o dermico esteso) nel mese precedente lo screening Il paziente presenta una condizione o si trova in una situazione che, secondo il parere dello sperimentatore, possa esporre il soggetto ad un rischio significativo, confondere i risultati dello studio o interferire in maniera significativa con la sua partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The average change from baseline in BCVA across all follow-up visits will be calculated for each patient.
    L'endpoint primario dell'efficacia corrisponde alla variazione media dal basale della BCVA nel corso di tutte le visite di follow up
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every visit - screening, randomization (Day 1), Month 1-12 visits.
    Ad ogni visita - screening, randomizzazione (giorno 1), Viste dei mesi da 1 a 12.
    E.5.2Secondary end point(s)
    Change from baseline in the foveal thickness based on optical coherence tomography (OCT). Change from baseline in total leakage area based on fluorescein angiography (FA).
    Cambiamenti dal basale dello spessore retinico centrale (SRC) misurato con OCT. Cambiamenti dal basale dell'area di perdita in angiografia con fluoresceina (FA, fluorescein angiography)
    E.5.2.1Timepoint(s) of evaluation of this end point
    OCT assessment at every visit (screening, randomization (Day1), Month 1-12 visits) FA assessment at screening, month 6 and month 12.
    Tomografie (OTC) veranno esuguite ad ogni visita (screening, randomizzazione,giorno 1 e viste mensili da 1 a 12). Angiografia con fluorescina verrà eseguita allo screening alla vista del mese 6 e del mese 12
    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 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 No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    South Africa
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months28
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months32
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 245
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects will return to the expected normal treatment of that condition
    I pazienti ritornerano alla terapia standard per la loro condizione
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Vision Institute Clinical Research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-13
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