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    Summary
    EudraCT Number:2020-004736-24
    Sponsor's Protocol Code Number:OPT-302-1004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004736-24
    A.3Full title of the trial
    A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
    Studio di fase 3, multicentrico, in doppio cieco, randomizzato, per valutare l’efficacia e la sicurezza di OPT-302 intravitreale in combinazione con ranibizumab, rispetto a ranibizumab in monoterapia, in pazienti affetti da degenerazione maculare neovascolare legata all’età (DMLE)
    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
    Uno studio clinico di OPT-302 con ranibizumab rispetto a ranibizumab in monoterapia in pazienti affetti da degenerazione maculare neovascolare
    A.3.2Name or abbreviated title of the trial where available
    ShORe
    ShORe
    A.4.1Sponsor's protocol code numberOPT-302-1004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04757610
    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 Limited
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOpthea Limited
    B.5.2Functional name of contact pointClinical Development Director
    B.5.3 Address:
    B.5.3.1Street AddressSuite 0403, Level 4, 650 Chapel Street
    B.5.3.2Town/ citySouth Yarra
    B.5.3.3Post codeVIC 3141
    B.5.3.4CountryAustralia
    B.5.4Telephone number0061398260399
    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 [OPT-302]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.9.4EV Substance CodeSUB191360
    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 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 10 mg/ml solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited, Ireland EU/1/06/374/003
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom (Northern Ireland)
    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.3.2Product code [na]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 codena
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravitreal use
    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 legata all’età (DMLE)
    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
    Malattia cronica occhi causa visione offuscata o punto cieco in un campo visivo causato da vasi sang normali che fuoriescono fluido o sangue nella parte della retina responsabile della vis centrale
    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 SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMD.
    Determinare l’efficacia di 2,0 mg di OPT-302 intravitreale somministrato in combinazione con 0,5 mg di ranibizumab intravitreale, in partecipanti con AMD neovascolare.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab from Baseline to (and at) Week 52 as determined by:
    Efficacy:
    • Changes in ETDRS BCVA letter score
    • Changes in anatomical parameters (CNV area, CST, SRF and IR cysts)
    • Changes in National Eye Institute 25-item Vision Function Questionnaire (NEI-VFQ-25) Participant Reported Outcomes (PROs).
    Safety:
    • Incidence of adverse events (AEs)
    • Deterioration in ETDRS BCVA letter score
    • Incidence of ADA formation
    Pharmacokinetic:
    • Pharmacokinetic parameters of OPT-302.
    Determinare gli effetti dell’aggiunta di 2,0 mg di OPT-302 intravitreale a 0,5 mg di ranibizumab intravitreale dal Basale fino alla (e alla) Settimana 52 in termini di:
    Efficacia:
    • Variazioni nel punteggio della massima acuità visiva corretta (BCVA) misurata con la scala ETDRS (Early Treatment Diabetic Retinopathy Study) per le lettere
    • Cambiamenti nei parametri anatomici (area di neovascolarizzazione coroideale [CNV], spessore del sottocampo centrale [CST], fluido sottoretinico [SRF] e cisti intraretiniche [IR])
    • Cambiamenti negli esiti riferiti dal paziente (PRO) nel questionario sulla funzione visiva a 25 domande del National Eye Institute (NEI-VFQ-25)
    Sicurezza:
    • Incidenza di eventi avversi (EA)
    • Peggioramento del punteggio della BCVA misurata con la scala ETDRS per le lettere
    • Incidenza della formazione di anticorpi anti-OPT-302 (ADA)
    Farmacocinetica:
    • Farmacocinetica di OPT-302.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female participants at least 50 years of age.
    • Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
    • An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
    • Partecipanti maschi o femmine di almeno 50 anni di età.
    • Lesione CNV subfoveale attiva o lesione CNV iuxtafoveale con coinvolgimento foveale secondario all’AMD nell’occhio in studio.
    • Un punteggio di BCVA all’ETDRS compreso tra 60 e 25 lettere (incluse) per l’occhio in studio.
    E.4Principal exclusion criteria
    Study Eye:
    • Any previous treatment for neovascular AMD.
    • Clinically significant ocular disorders (other than neovascular AMD), which may, in the investigator’s opinion, interfere with assessment of BCVA, assessment of safety, or fundus imaging.
    • Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

    Note: other protocol exclusion criteria may also apply.
    Occhio in studio:
    • Qualsiasi trattamento precedente per AMD neovascolare
    • Disturbi oculari clinicamente significativi (diversi dall’AMD neovascolare) che, a giudizio dello sperimentatore, possono interferire con la valutazione della BCVA, la valutazione della sicurezza o le immagini del fondo oculare.
    • Qualsiasi infezione oculare o perioculare in corso

    NOTE: possono applicarsi anche altri criteri di esclusione del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters from Baseline to Week 52
    Variazione media dal basale alla settimana 52 della BCVA, misurata con la scala ETDRS per le lettere
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settinama 52
    E.5.2Secondary end point(s)
    Efficacy:
    • Proportion of participants gaining 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters from Baseline to Week 52
    • Proportion of participants gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters from Baseline to Week 52
    • Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by SD-OCT at Week 52
    • Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) from Baseline to Week 52
    • Change in central sub-field thickness (CST) by spectral domain optical coherence tomography (SD-OCT) from Baseline to Week 52
    • Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score from Baseline to Week 52
    • Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.
    Efficacia
    • Percentuale di partecipanti che ottengono un punteggio di 10 o più di BCVA all’ETDRS sulle lettere dal basale alla settimana 52
    • Percentuale di partecipanti che ottengono un punteggio di 15 o più della BCVA all’ETDRS sulle lettere dal basale alla settimana 52
    • Percentuale di partecipanti con assenza di cisti sia SRF sia IR mediante tomografia a coerenza ottica nel dominio spettrale (SD-OCT) alla settimana 52
    • Variazione dell’area CNV misurata mediante angiografia con fluoresceina (FA) dal basale alla settimana 52
    • Variazione del CST rilevata da SD-OCT dal basale alla settimana 52
    • Variazione del punteggio composito al questionario NEI VFQ-25 dal basale alla settimana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    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 No
    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) 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
    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 concerned8
    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 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
    Australia
    Brazil
    Canada
    India
    Israel
    Korea, Republic of
    Malaysia
    Russian Federation
    Thailand
    Ukraine
    United States
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Italy
    Latvia
    Poland
    Spain
    United Kingdom
    Czechia
    Argentina
    Greece
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 890
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 990
    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 Decision2021-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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