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    Summary
    EudraCT Number:2005-001460-32
    Sponsor's Protocol Code Number:EOP1013B
    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:2005-12-22
    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 number2005-001460-32
    A.3Full title of the trial
    A phase 2/3 randomized, controlled, double-masked, multicenter, comparative trial, in parallel groups, to compare the safety and efficacy of intravitreous injections of 0.3 mg pegaptanib sodium (Macugen), given as often as every 6 weeks for 2 years, to sham injections in subjects with diabetic macular edema (DME) involving the center of the macula with an openlabel Macugen year 3 extension.
    Studio di fase 2/3 comparativo, multicentrico, con doppio mascheramento, controllato, randomizzato, a gruppi paralleli, per confrontare la sicurezza e l'efficacia di iniezioni intravitreali da 0.3, mg di sodio pegaptanib (Macugen), somministrato ogni 6 settimane per 2 anni, mediante il confronto con finte iniezioni in soggetti affetti da edema maculare diabetico (EMD) che interessa la parte centrale della macula con estensione del trattamento in aperto con Macugen per un terzo anno.
    A.4.1Sponsor's protocol code numberEOP1013B
    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 SponsorPfizer Inc
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 MACUGEN
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegaptanib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number.3
    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 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 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 confirm the safety and compare the efficacy of pegaptanib sodium when given as intravitreous injections of 0.3 mg/eye versus sham injections in a 1:1 ratio, respectively. All subjects previously randomized to the 0.03 or 0.003 mg/eye treatment arms during the conduct of EOP1013 through EOP1013C will be given the option of either receiving injections of 0.3 mg/eye or withdrawing from the study. Injections will be given as often as every 6 weeks for 2 years, in subjects with diabetic macular edema involving the center of the macula associated with vision loss not due to ischemia.
    la conferma della sicurezza e il confronto dell'efficacia tra iniezioni intravitreali di sodio pegaptanib da 0,3 mg/occhio e finte iniezioni in rapporto rispettivamente di 1:1. A tutti i soggetti precedentemente randomizzati nei bracci 0.03 o 0.003 mg/occhio durante lo svolgimento dei protocolli da EOP1013 a EOP1013C verra' chiesto se desiderano continuare lo studio ricevendo iniezioni di Pegaptanib 0.3 mg/occhio oppure se desiderano ritirarsi dallo studio. Le iniezioni verranno effettuate ogni 6 settimane per 2 anni, in soggetti affetti da edema maculare diabetico che interessa la parte centrale della macula ed e` associato a perdita della vista non a causa di ischemie.
    E.2.2Secondary objectives of the trial
    -
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -
    Possono essere arruolati soggetti di entrambi i sessi, che abbiano gia` compiuto 18 anni, con diagnosi di edema maculare diabetico che interessa i centro della macula (definito come spessore del punto centrale misurato tramite OCT pari almeno a 250 micron), con acuita` visiva corretta al meglio pari o inferiore a un punteggio di 65 lettere (circa 20/50 equivalente Snellen), ma non peggiore di 35 (circa 20/200 equivalente Snellen), nell'occhio in studio. Le donne in eta` fertile utilizzeranno due metodi contraccettivi efficaci per l'intera durata dello studio.
    E.4Principal exclusion criteria
    -
    Principali criteri di esclusione. Necessita` di fotocaogulazione nell'occhio affetto entro i successivi 9 mesi o fotocoagulazione effettuata nei 6 mesi precedenti la visita di screening, trazione vitreoretinica come confermato da OCT, qualsiasi altra causa di edema maculare, atrofia/cicatrici/fibrosi che coinvolgono il centro della macula, trattamento fotocoagulativo o laser nei 4 mesi precedenti (focale o a griglia), HbA1C&gt;= 10% o segni recenti di diabete non controllato, significative opacita` dei mezzi diottrici, malattie dei vari organi o apparati (cardiovascolare, renale, epatico, ecc.) clinicamente significative.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects exhibiting an improvement of >10 letters (or 2-lines) of vision (ETDRS) from baseline. The 1 year endpoint is the primary endpoint, while the 2 year endpoint will be the secondary endpoint.
    La proporzione di soggetti che presentano un miglioramento > 10 lettere (o 2 gradi) di vista (ETDRS) rispetto alla fase baseline. Questo endpoint verra` valutato al primo anno per testare la significativita` della comparazione tra la proporzione di 2 gradi di miglioramento nel gruppo con dosaggio di 0.3 mg/occhio verso coloro che ricevono il finto trattamento. L'endpoint ad 1 anno e` l'endpoint primario
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sham injection - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 300
    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 Decision2006-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-15
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