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    Summary
    EudraCT Number:2017-002698-20
    Sponsor's Protocol Code Number:OPT-302-1002
    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:2020-12-11
    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 number2017-002698-20
    A.3Full title of the trial
    A dose-ranging study of intravitreal OPT-302 in combination with
    ranibizumab, compared with ranibizumab alone, in participants with
    neovascular age-related macular degeneration (wet AMD)
    Studio a dosi variabili di OPT-302 intravitreale in combinazione con ranibizumab, confrontato con ranibizumab in monoterapia, in partecipanti con degenerazione maculare neovascolare correlata all¿et¿ (DMS umida).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of OPT-302 with ranibizumab compared to ranibizumab
    alone in patients with neovascular age-related macular degeneration
    Studio clinico di OPT-302 con ranibizumab, confrontato con ranibizumab in monoterapia, in pazienti con degenerazione maculare neovascolare correlata all¿et¿.
    A.3.2Name or abbreviated title of the trial where available
    A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovasc
    Studio clinico di OPT-302 con ranibizumab, confrontato con ranibizumab in monoterapia, in pazienti c
    A.4.1Sponsor's protocol code numberOPT-302-1002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03345082
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorOPTHEA LIMITED
    B.1.3.4CountryAustralia
    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 supportOpthea Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOpthea Ltd
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street Address650 Chapel Street
    B.5.3.2Town/ citySouth Yarra
    B.5.3.3Post codeVIC 3141
    B.5.3.4CountryAustralia
    B.5.4Telephone number61398260399
    B.5.5Fax number61398240083
    B.5.6E-mailclare.price@opthea.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 No
    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 nameOPT-302
    D.3.2Product code -
    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 INNVascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed INN at this stage)
    D.3.9.2Current sponsor codeOPT-302
    D.3.9.3Other descriptive nameVascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed INN at this stage)
    D.3.9.4EV Substance Code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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 - 10MG/ML - SOLUZIONE INIETTABILE - USO INTRAVITREO - SIRINGA PRERIEMPITA 0,165 ML - 1 SIRINGA PRERIEMPITA
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    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.3.1Product name-
    D.3.2Product code -
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Neovascular age-related macular degeneration (wet AMD)
    Degenerazione maculare neovascolare correlata all'età (DMS umida)
    E.1.1.1Medical condition in easily understood language
    Chronic eye disease that causes blurred vision or a blind spot in one¿s
    visual field caused by abnormal blood vessels leaking fluid or blood into
    the part of the retina responsible for central vision
    Degenerazione maculare neovascolare correlata all'età (DMS umida)
    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 PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10067791
    E.1.2Term Wet macular degeneration
    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 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
    Determine the efficacy of two different doses of intravitreal OPT-302
    when administered in combination with ranibizumab in participants with
    wet AMD
    Determinare l¿efficacia di due differenti dosi di OPT-302 intravitreale quando somministrato in combinazione con ranibizumab in partecipanti affetti da DMS umida.
    E.2.2Secondary objectives of the trial
    * Determine the proportion of participants gaining 15 or more ETDRS
    BCVA letters from Baseline to Week 24;
    * Determine the area under the ETDRS BCVA over time curve;
    * Determine the change in central subfield thickness (CST) on spectral
    domain optical coherence tomography (SD-OCT) from Baseline to Week
    24;
    * Determine the change in sub-retinal fluid on SD-OCT from Baseline to
    Week 24;
    * Determine the presence or absence of intra-retinal fluid on SD-OCT
    from Baseline to Week 24;
    * Determine the proportion of participants losing 15 or more letters (on
    ETDRS BCVA chart) from Baseline to the Week 24 Visit;
    * Determine the safety of OPT-302 in combination with ranibizumab;
    * Determine the pharmacokinetic parameters of OPT-302;
    * Determine the incidence of anti-OPT-302 antibody (ADA) formation.
    * Determinare la percentuale di partecipanti che acquisiscono 15 o pi¿ lettere alla BCVA ETDRS dalla baseline alla Settimana 24;
    * Determinare l¿area sotto la curva BCVA ETDRS nel tempo;
    * Determinare la variazione dello spessore nel settore centrale (CST) rilevata dalla tomografia a coerenza ottica ad alta definizione nel dominio spettrale (SD-OCT) dalla baseline alla Settimana 24;
    * Determinare la variazione del fluido sottoretinico rilevata da SD-OCT dalla baseline alla Settimana 24;
    * Determinare la presenza o l¿assenza di fluido intraretinico rilevata da SD-OCT dalla baseline alla Settimana 24;
    * Determinare la percentuale di partecipanti che perdono 15 o pi¿ lettere (sulla tavola per la BCVA ETDRS) dalla baseline alla Visita della Settimana 24;
    * Determinare la sicurezza di OPT-302 in combinazione con ranibizumab;
    * Determinare i parametri farmacocinetici di OPT-302;
    * Determinare l¿incidenza della formazione di anticorpi anti-OPT-302 (ADA)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacokinetic Sub-Study
    * Objective: To gather further pharmacokinetic data for OPT-302 to build
    on the population PK (PopPK) model developed using the PK data from
    study OPT-302-1001


    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di farmacocinetica
    Obiettivo: Raccogliere ulteriori dati di farmacocinetica per OPT-302 per estendere il modello relativo alla popolazione PK (PopPK) sviluppato utilizzando i dati di PK provenienti dallo studio OPT-302-1001
    E.3Principal inclusion criteria
    STUDY EYE
    1. Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal
    CNV lesion (1-199 µm from the fovea) with subfoveal involvement
    (demonstrated by leakage on fluorescein angiography (FA) and/or intraretinal
    or sub-retinal fluid on spectral-domain optical coherence
    tomography
    [SD-OCT]) secondary to age-related macular degeneration
    (AMD).
    Active CNV as measured on FA must constitute at least 50% of
    the
    lesion area, with a total lesion size of = 30.5 mm2. The lesion may
    contain
    classic and/or occult CNV, but any occult CNV present must
    measure
    < 10 mm2 on the FA. The characteristics of each lesion must be
    confirmed
    by the Independent Reading Centre.
    2.
    A best corrected (ETDRS) visual acuity (BCVA) score between 60 and
    25
    (inclusive) letters (Snellen equivalent of 20/63 (feet) or 6/21
    (metres)
    and 20/320 (feet) or 6/96 (metres) respectively).
    GENERAL
    1. Willing and able to provide written informed consent.
    2. Male or female participants at least 50 years of age.
    3. Able to understand and willing to comply with study protocol
    procedures and restrictions.
    4. If female and of child-bearing potential: Pregnancy test at Screening
    is negative, and agrees to use a highly effective method of contraceptive
    for the duration of the study and for at least 3 months following the last
    dose of study medication.
    OCCHIO IN STUDIO
    1. Lesione con neovascolarizzazione coroideale (CNV) subfoveale attiva o lesione CNV iuxtafoveale (1-199 µm dalla fovea) con coinvolgimento subfoveale (dimostrato da perdite rilevate da angiografia con fluoresceina (FA) e/o fluido intraretinico o sottoretinico rilevato da tomografia a coerenza ottica ad alta definizione nel dominio spettrale [SD-OCT]) secondaria alla degenerazione maculare neovascolare correlata all’età (DMS). La CNV attiva misurata da FA deve costituire almeno il 50% dell'area della lesione, con una dimensione totale della lesione di = 30,5 mm2. La lesione può contenere CNV classica e/o occulta, ma eventuale CNV occulta presente deve misurare < 10 mm2 dall’FA. Le caratteristiche di ciascuna lesione devono essere confermate dal Centro di lettura indipendente.
    2. Un punteggio della miglior acuità visiva corretta (BCVA) (ETDRS) compreso tra 60 e 25 (incluso) lettere (equivalente snellen di 20/63 piedi o 6/21 metri, e 20/320 piedi o 6/96 metri rispettivamente).
    GENERALI
    1. Volontà e capacità di fornire un consenso informato scritto.
    2. Partecipanti di sesso maschile o femminile di almeno 50 anni.
    3. Capacità di comprendere e volontà di rispettare le procedure e le restrizioni del protocollo dello studio.
    4. Se di sesso femminile ed in età fertile: Test di gravidanza negativo allo Screening e consenso all’utilizzo di un metodo contraccettivo altamente efficace per la durata dello studio e per almeno 3 mesi dopo l’ultima dose di farmaco in studio.
    E.4Principal exclusion criteria
    STUDY EYE
    1 Any previous treatment for wet AMD

    2 Clinically significant ocular disorders other than wet

    3 Haemorrhage measuring more than 50% of total lesion area

    4 Fibrosis involving either the fovea centre or measuring more than
    25% of the total lesion area and/or juxtafoveal or sub-foveal geographic
    Atrophy

    5 Choroidal neovascularisation due to causes other than AMD

    6 Cloudy ocular media, or inadequate pupillary dilatation

    7 Presence of intraocular inflammation (= trace cell or flare), significant
    epiretinal membrane or vitreomacular traction, macular hole or vitreous
    haemorrhage

    8 Aphakia or absence of the posterior capsule

    9 History of idiopathic or autoimmune-associated uveitis
    10. Any current ocular or periocular infection

    11 Intraocular pressure of greater than 25 mmHg

    12 Myopia, or known former myopia, with a spherical equivalent of
    Greater than 8 dioptres

    13 Intraocular surgery within 6 months prior to screening, except for
    Cataract surgery that is excluded within 3 months of Screening.

    14 History of any of the following conditions or procedures:
    Rhegmatogenous retinal detachment, filtering surgery
    glaucoma drainage device, or corneal transplant.

    15 Prior pars plana vitrectomy.

    16 Presence of an intravitreal device.
    17 Retinopathy

    NON-STUDY EYE
    History of idiopathic, autoimmune-associated, or infectious uveitis

    GENERAL
    1 diabetes mellitus
    2 Administration of systemic steroids within 3 months of screening
    3 Symptoms of heart failure
    4 Unstable angina, myocardial infarction or coronary artery revascularisation within 6 months of screening.
    5 Ventricular tachyarrhythmia requiring ongoing treatment
    6 Vascular stenting within 6 months of screening
    7 Cerebrovascular event
    8 Diastolic blood pressure > 100 mmHg at screening.
    9 Renal failure requiring dialysis or transplant.
    10. ALT or AST = 2 x upper limit of normal or total bilirubin = 1.5
    x ULN unless due to genetically confirmed Gilbert's disease
    11 Any major surgical procedure
    12 Active systemic infection
    13 Malignancy within 5 years of screening, with the exception of
    carcinoma in situ, non-melanoma skin cancers and prostate cancer not
    requiring treatment or on stable (> 6 months) treatment with hormone
    therapy
    14 Known serious allergies to the fluorescein or hypersensitivity to
    any of the listed excipients in the OPT-302 formulation or components of
    the ranibizumab formulation
    15 Pregnant, within 3 months after the end of pregnancy, planning to
    become pregnant, or lactating.
    16 Previous administration of anti-VEGF-A therapies except by intravitreal injection in the non-Study Eye
    17 Administration of an investigational drug or ocular device within 30
    days of screening, or 5 half-livesor any prior
    treatment with OPT-302
    18 Any social or medical condition that, in the Investigator's opinion,
    would preclude enrolment into the study
    OCCHIO IN STUDIO
    1 Eventuale trattamento precedente per la DMS umida
    2 Disturbi oculari clinicamente significativi diversi dalla DMS umida
    3 Emorragia che misura più del 50% dell’area totale della lesione
    4 Fibrosi che coinvolge il centro della fovea o che misura più del 25% dell’area totale della lesione e/o atrofia geografica subfoveale o iuxtafoveale
    5 Neovascolarizzazione coroideale dovuta a cause diverse dalla DMS
    6 Media oculare non chiara o dilatazione delle pupille inadeguata
    7 Presenza di infiammazione intraoculare, membrana epiretinica o trazione vitreomaculare significativa, perforazione maculare o emorragia del corpo vitreo
    8 Afachia o assenza di capsula posteriore
    9 Anamnesi di uveite idiopatica o auto-immune
    10 Eventuale infezione oculare o perioculare attuale
    11 Pressione intraoculare superiore a 25 mmHg
    12 Miopia con equivalente sferico superiore a 8 diottrie.
    13 Intervento chirurgico intraoculare nei 6 mesi precedenti lo screening, ad eccezione di intervento chirurgico per cataratta che è escluso entro 3 mesi dallo Screening
    14 Anamnesi di qualsiasi delle seguenti condizioni e procedure:
    Distacco regmatogeno della retina, chirurgia filtrante, dispositivo di drenaggio del glaucoma o trapianto della cornea
    15 Precedente vitrectomia della pars plana
    16 Presenza di dispositivo intravitreale
    17 Retinopatia

    OCCHIO NON IN STUDIO
    Anamnesi di uveite idiopatica, auto-immune o infettiva

    INFORMAZIONI GENERALI
    1 Diabete mellito
    2 Somministrazione di steroidi sistemici entro 3 mesi dallo screening
    3 Sintomi di insufficienza cardiaca
    4 Angina instabile, infarto miocardico o rivascolarizzazione arteriosa coronarica entro 6 mesi dallo screening
    5 Tachiaritmia ventricolare che richiede trattamento in corso
    6 Stenting vascolare entro 6 mesi dallo screening
    7 Evento cerebrovascolare
    8. Pressione sanguigna diastolica > 100 mmHg allo screening
    9 Insufficienza renale che richiede dialisi o trapianto.
    10. ALT o AST = 2 x il limite superiore della norma o bilirubina totale = 1,5 x ULN salvo se dovuta a malattia di Gilbert confermata geneticamente
    11 Eventuale intervento chirurgico importante
    12 Infezione sistemica attiva
    13 Tumore maligno entro 5 anni dallo screening, con l’eccezione di carcinoma in situ, carcinomi cutanei non melanomatosi e carcinoma prostatico che non richiedono trattamento o che sono in trattamento stabile (> 6 mesi) con terapia ormonale
    14 Note allergie serie alla fluorescina o ipersensibilità a uno qualsiasi degli eccipienti elencati nella formulazione di OPT-302 o dei componenti della formulazione di ranibizumab
    15 Gravidanza, entro 3 mesi dopo la fine della gravidanza, intenzione di iniziare una gravidanza, allattamento al seno
    16 Somministrazione precedente di terapie anti-VEGF-A ad eccezione di iniezione intravitreale nell’occhio non in studio
    17 Somministrazione di un farmaco sperimentale o di un dispositivo oculare entro 30 giorni dallo screening o 5 emivite o eventuale trattamento precedente con OPT-302
    18 Qualsiasi condizione sociale o medica che precluderebbe l’arruolamento nello studio
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from Baseline in Early Treatment Diabetic Retinopathy
    Study (ETDRS) best corrected visual acuity (BCVA) letters to Week 24
    (Visit 8)
    Variazione media dalla baseline delle lettere della miglior acuità visiva corretta (BCVA) nell’ambito dello studio del trattamento precoce della retinopatia diabetica (ETDRS - Early Treatment Diabetic Retinopathy Study) alla Settimana 24 (Visita 8).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24 (Visit 8)
    Settimana 24 (Visita 8)
    E.5.2Secondary end point(s)
    The proportion of participants gaining 15 or more ETDRS BCVA letters
    from Baseline to the Week 24 Visit;
    * Area under the ETDRS BCVA-over-time curve;
    * Change in CST on SD-OCT from Baseline to Week 24;
    * Change in sub-retinal fluid on SD-OCT from Baseline to Week 24;
    * Presence or absence of intra-retinal fluid determined by the presence
    or absence of intra-retinal cysts on SD-OCT from Baseline to Week 24;
    * Proportion of participants losing 15 or more letters (on ETDRS BCVA
    chart) from Baseline to the Week 24 Visit;
    * Incidence of ocular and non-ocular adverse events (AEs);
    * OPT-302 pharmacokinetic parameters;
    * Participant incidence of ADA formation.
    * Percentuale di partecipanti che acquisiscono 15 o pi¿ lettere alla BCVA ETDRS dalla baseline alla Visita della Settimana 24;
    * Area sotto la curva BCVA ETDRS nel tempo;
    * Variazione del CST rilevata da SD-OCT dalla baseline alla Settimana 24;
    * Variazione del fluido sottoretinico rilevata da SD-OCT dalla baseline alla Settimana 24;
    * Presenza o assenza di fluido intraretinico determinata dalla presenza o assenza di cisti intraretiniche rilevata da SD-OCT dalla baseline alla Settimana 24;
    * Percentuale di partecipanti che perdono 15 o pi¿ lettere (sulla tavola per la BCVA ETDRS) dalla baseline alla Visita della Settimana 24;
    * Incidenza di eventi avversi (AE) oculari e non oculari;
    * Parametri farmacocinetici di OPT-302;
    * Incidenza della formazione di ADA nei partecipanti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 (Visit 8)
    Settimana 24 (Visita 8)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    iniezione sham
    Sham injection
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czechia
    France
    Hungary
    Israel
    Italy
    Latvia
    Poland
    Spain
    United Kingdom
    United States
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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.1.1.1In 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 326
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 351
    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)
    NA
    NA
    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 Decision2018-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
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