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    Summary
    EudraCT Number:2020-004694-46
    Sponsor's Protocol Code Number:OPT-302-1005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-004694-46
    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 Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
    Estudio en fase III, multicéntrico, doble ciego y aleatorizado para evaluar la eficacia y seguridad de OPT-302 intravítreo en combinación con aflibercept, en comparación con aflibercept en monoterapia, en participantes con degeneración macular asociada a la edad (DMAE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneration
    Estudio de OPT-302 en combinación con aflibercept, en comparación con aflibercept solo, en participantes con degeneración macular asociada a la edad.
    A.3.2Name or abbreviated title of the trial where available
    COAST
    A.4.1Sponsor's protocol code numberOPT-302-1005
    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
    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 organisationFISABIO
    B.5.2Functional name of contact pointMaria Carmen Desco Esteban
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Pío Baroja, 12
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46015
    B.5.3.4CountrySpain
    B.5.4Telephone number+34962 78 76 20
    B.5.6E-mailcarmen.desco@uv.es
    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
    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 nameOPT-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 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 Eylea 40mg/ml solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG, Germany
    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.3.1Product nameAflibercept
    D.3.4Pharmaceutical form Solution for infusion 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 INNAflibercept
    D.3.9.1CAS number 862111-32-8
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    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 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
    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)
    Degeneración macular asociada a la edad (DMAE) exudativa.
    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
    Enfermedad ocular crónica que causa visión borrosa o un punto ciego en el campo visual causado por vasos sanguíneos anormales que filtran líquido/sangre en la parte de la retina.
    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 2.0 mg aflibercept, in participants with neovascular AMD.
    Determinar la eficacia de 2,0 mg de OPT-302 intravítreo cuando se administra en combinación con 2,0 mg de aflibercept intravítreo en participantes con DMAE exudativa
    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 2.0 mg aflibercept 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.
    Determinar los efectos de la adición de 2,0 mg de OPT-302 intravítreo a 2,0 mg de aflibercept intravítreo desde el inicio hasta (y en) la semana 52 en cuanto a:
    Eficacia:
    • Cambios en la puntuación de agudeza visual con la mejor corrección (AVMC) de la prueba del estudio de tratamiento precoz de la retinopatía diabética (ETDRS)
    • Cambios en los parámetros anatómicos (área de neovascularización coroidea [NVC], grosor del subcampo macular central [GSMC], líquido subretiniano [LSR] y quistes intrarretinianos [IR])
    • Cambios en los resultados comunicados por los participantes (RCP) mediante el cuestionario de 25 elementos sobre función visual del National Eye Institute (NEIVFQ-25)
    Seguridad:
    • Incidencia de los acontecimientos adversos (AA)
    • Disminución de la puntuación de AVMC evaluada con la prueba ETDRS
    • Incidencia de la formación de anticuerpos (AAF) contra OPT-302
    Farmacocinética:
    • Farmacocinética del 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.
    • Participantes varones o mujeres de al menos 50 años de edad.
    • Lesión activa por NVC subfoveal o lesión por NVC yuxtafoveal (entre 1-199 μm de la fóvea) con afectación de la fóvea (confirmada con un derrame medido por angiografía fluoresceínica [AF] o líquido intrarretiniano o líquido subretiniano mediante TCO-DE) secundaria a la DMAE en el ojo evaluado
    • Una puntuación de AVMC evaluada con la prueba ETDRS de entre 60 y 25 letras (ambas inclusive) en el ojo evaluado.
    E.4Principal exclusion criteria
    Study Eye
    • Any previous treatment for neovascular AMD.
    • Clinically significant ocular disorders (other than neovascular AMD), which may 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.
    Ojo evaluado:
    • Cualquier tratamiento previo para la DMAE exudativa.
    • Trastornos oculares de importancia clínica (distintos de la DMAE exudativa), que puedan, a criterio del investigador, interferir con la evaluación de la AVMC, la evaluación de la seguridad o la obtención de imágenes del fondo de ojo.
    • Cualquier condición médica, psicológica o social actual (o antecedentes de una) que impida la inscripción en el estudio.

    Nota: aplican otros criterios de exclusión según protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
    Cambio medio desde el inicio hasta la semana 52 en la puntuación de AVMC evaluada con la prueba ETDRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 Weeks
    52 semanas
    E.5.2Secondary end point(s)
    Efficacy
    • Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
    • Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
    • Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: at Week 52 ]
    • Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) [ Time Frame: Baseline to Week 52 ]
    • Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 52 ]
    • Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score [ Time Frame: Baseline to Week 52 ]
    • Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.
    Eficacia
    • Proporción de participantes que alcanzan una puntuación de AVMC de 10 o más letras, evaluada con la prueba ETDRS, desde el inicio hasta la semana 52
    • Proporción de participantes que alcanzan una puntuación de AVMC de 15 o más letras, evaluada con la prueba ETDRS, desde el inicio hasta la semana 52
    • Proporción de participantes con ausencia de líquido subretiniano y quistes intrarretinianos mediante tomografía de coherencia óptica de dominio espectral (TCO-DE) en la semana 52
    • Cambio en el área de neovascularización coroidea por angiografía fluoresceínica (AF) desde el inicio hasta la semana 52
    • Cambio en el grosor del subcampo macular central medido por TCO-DE desde el inicio hasta la semana 52
    • Cambio en la puntuación compuesta de NEI VFQ-25 desde el inicio hasta la semana 52
    • Cambio en la puntuación compuesta media de 25 preguntas. Un cambio medio más alto significa una mejora general en la función visual.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 Weeks
    52 semanas
    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
    Inyección simulada
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    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
    Australia
    Brazil
    Canada
    Colombia
    India
    Israel
    Korea, Republic of
    Malaysia
    Philippines
    Puerto Rico
    Russian Federation
    Taiwan
    Ukraine
    United States
    Austria
    Bulgaria
    Croatia
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Slovakia
    Spain
    United Kingdom
    Czechia
    Argentina
    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
    Última visita último paciente
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 319
    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
    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 Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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