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    Summary
    EudraCT Number:2013-003017-18
    Sponsor's Protocol Code Number:OPH1003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-10-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-003017-18
    A.3Full title of the trial
    A phase 3 randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of FovistaTM (anti PDGF-b pegylated aptamer) administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal neovascular age-related macular degeneration.
    Ensayo controlado de fase 3, aleatorizado y en doble ciego, para determinar la seguridad y la eficacia de la administración intravítrea de FovistaTM (aptámero pegilado anti PDGF-b) administrado en combinación con Lucentis®, en comparación con Lucentis® en monoterapia, en sujetos con neovascularización subfoveal secundaria a degeneración macular asociada a la edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to establish the safety and efficacy of intravitreous administration of Fovista TM administered in combination with Lucentis® compared to Lucentis® administered alone in subjects with subfoveal neovascular age-related macular degeneration.
    Ensayo clínico para determinar la seguridad y la eficacia de la administración intravítrea de FovistaTM administrado en combinación con Lucentis®, en comparación con Lucentis® administrado solo, en sujetos con neovascularización subfoveal degeneración macular asociada a la edad.
    A.4.1Sponsor's protocol code numberOPH1003
    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 SponsorOPHTHOTECH CORPORATION
    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 supportOPHTHOTECH CORPORATION
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPHTHOTECH CORPORATION
    B.5.2Functional name of contact pointLoni da Silva
    B.5.3 Address:
    B.5.3.1Street AddressOne Penn Plaza - 35th Floor
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10119
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 732 2789999
    B.5.5Fax number+1 609 452 7435
    B.5.6E-mailLoni.daSilva@ophthotech.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 nameFovista
    D.3.2Product code E10030
    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 INNFovista
    D.3.9.1CAS number 1449390-73-1
    D.3.9.2Current sponsor codeE10030
    D.3.9.3Other descriptive nameE10030
    D.3.9.4EV Substance CodeSUB126298
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 10 mg/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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 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 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
    Subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
    Neovascularización coroidea subfoveal secundaria a degeneración macular asociada a la edad (DMAE)
    E.1.1.1Medical condition in easily understood language
    Subfoveal choroidal neovascularization in addition to age-related macular degeneration
    Neovascularización coroidea subfoveal además de la degeneración macular asociada a la edad (DMAE)
    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 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10067791
    E.1.2Term Wet macular degeneration
    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
    The objectives of this study are to evaluate the safety and efficacy of Fovista TM intravitreous administration when administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
    Los objetivos de este estudio son evaluar la seguridad y eficacia de la administración intravítrea de Fovista TM en combinación con Lucentis®, en comparación con Lucentis® en monoterapia, en sujetos con neovascularización coroidal subfoveal secundaria a degeneración macular asociada a la edad (DMAE).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ophthalmic Inclusion Criteria
    The following inclusion criteria apply to the study eye:
    .Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component (i.e., predominantly classic or minimally classic) as documented by fluorescein angiogram.
    .Best corrected visual acuity in the study eye between 20/63 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization.
    .Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be </= 5 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as leakage on fluorescein angiogram AND subretinal or intraretinal fluid on OCT.
    .Presence on OCT of subretinal, intraretinal or sub-RPE fluid and/or subretinal thickening/reflectivity consistent with active CNV.
    .Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed by the central reading center.
    .Intraocular pressure (IOP) of 21 mmHg or less.

    General Inclusion Criteria
    .Subjects of either gender aged >/= 50 years.
    .Performance Status </= 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale.
    .Women must agree to be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
    .Provide written informed consent.
    .Ability to comply with study and follow-up procedures and return for all trial visits.
    Criterios de inclusión oftalmológicos
    Los siguientes criterios de inclusión serán de aplicación para el ojo en estudio:
    .Neovascularización coroidea subfoveal (NCS) debida a AMD con algún grado de componente clásico (es decir, predominantemente o mínimamente clásica), de acuerdo con lo documentado en la angiografía fluoresceínica.
    .Mejor agudeza visual corregida en el ojo en estudio entre 20/63 y 20/200, inclusive. La AV deberá reconfirmarse en el día 1, antes de la aleatorización.
    .El área total de la lesión (incluida la sangre, neovascularización y las cicatrices/atrofias) deberá ser de </= 5 áreas papilares (AP), y un 50% de la misma como mínimo deberá corresponder a NCS activa. La NCS activa se define como extravasaciones en la angiografía fluoresceínica Y presencia de líquido sub o intrarretiniano en la OCT.
    .Presencia de líquido sub o intrarretiniano o sub-EPR en la OCT y/o engrosamiento/reflectividad subretiniana compatible con NCS activa.
    .Medios oculares transparentes y dilatación pupilar adecuada, que permitan realizar fotografías del fondo de ojo y angiografías fluoresceínicas de la suficiente calidad como para ser analizadas por el centro de lectura centralizado.
    .Presión intraocular (PIO) de 21 mmHg o menos.

    Criterios de inclusión generales
    .Sujetos de ambos sexos, de edad >/= 50 años.
    .Estado funcional </= 2 según la escala del Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO)
    .Las mujeres deberán estar de acuerdo en utilizar dos formas de anticoncepción efectivas, ser post-menopáusicas desde hace 12 meses como mínimo antes de ser incluidas en el estudio, o haber sido esterilizadas quirúrgicamente; en el caso de ser mujeres en edad fértil deberán someterse a una prueba de embarazo en suero en los 14 días previos a la primera inyección, con resultado negativo. Las dos formas de anticoncepción efectiva deberán utilizarse durante el estudio y como mínimo durante los 60 siguientes a la última dosis de medicación del estudio.
    .Otorgar el consentimiento informado por escrito.
    .Ser capaz de cumplir con los procedimientos del estudio y con el seguimiento del mismo, y acudir a todas las visitas del estudio.
    E.4Principal exclusion criteria
    Ophthalmic Exclusion Criteria
    .Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals.
    .Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids).
    .More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded.
    .More than 50% of the total lesion size consisting of subretinal hemorrhage.
    .Presence of retinal angiomatous proliferation (RAP).
    .Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion.
    .Presence of pigment epithelial tears or rips.
    .Presence of intraocular inflammation (>/= trace cell or flare), significant epiretinal membrane or vitreomacular traction, macular hole or vitreous hemorrhage.
    .Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation.
    .History of idiopathic or autoimmune-associated uveitis in either eye.
    .Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 12 months.
    .Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
    .Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
    .Any ocular or periocular infection in the past twelve (12) weeks.
    .History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.
    .Previous therapeutic radiation in the region of the study eye.

    General Exclusion Criteria
    .Any of the following underlying conditions or diseases including:
    Diabetes mellitus (regardless of HbA1c level)
    HbA1c >/= 6.5%. If the patient has no signs or symptoms of diabetes mellitus, the HbA1c may be repeated once.
    If the HbA1c remains >/= 6.5% on the repeat test, the patient must be excluded.
    If the HbA1c is <6.5% on the repeat test, the patient may be enrolled.
    History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
    History or evidence of severe cardiac disease (e.g., NYHA
    Functional Class III or IV - see Appendix 17.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrythmias requiring ongoing treatment.
    Stroke (within 12 months of trial entry).
    Any major surgical procedure within one month of trial entry.
    .Any treatment with an investigational agent in the 60 days prior to randomization for any condition.
    .Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), or to the components or formulation of either Fovista TM or Lucentis®.
    Criterios de exclusión
    .Cualquier tratamiento previo para la DMAE en el ojo de estudio antes de la visita del día 1, a excepción de los suplementos de vitaminas y minerales por vía oral.
    .Cualquier tratamiento intravítreo previo en el ojo de estudio antes de la visita del día 1, independientemente de su indicación (incluye los corticoides intravítreos).
    .Más de un 25% del tamaño total de la lesión constituido por tejido cicatricial o atrófico. Los sujetos con cicatrices subfoveales o atrofia subfoveal quedarán excluidos del estudio.
    .Más de un 50% del tamaño total de la lesión constituido por hemorragia subretiniana.
    .Presencia de proliferación angiomatosa retiniana (PAR).
    .Presencia de desprendimientos serosos del epitelio pigmentario significativos (DEP), como aquellos cuyo tamaño representa más de un 50% del tamaño total de la lesión.
    .Presencia de desgarros o roturas del epitelio pigmentario.
    .Presencia de inflamación intraocular (>/= células inflamatorias o "flare"), tracción vitreomacular o de la membrana epirretiniana significativa, agujero macular o hemorragia vítrea.
    .Afaquia o ausencia de la cápsula posterior del cristalino. Se permite la ausencia de una cápsula posterior intacta si tuvo lugar como resultado de la implantación previa de una lente intraocular en la cámara posterior, debido a una capsulotomía posterior con láser YAG.
    .Antecedentes de uveítis idiopática o autoinmune en cualquiera de los dos ojos.
    .Opacidad de medios significativa, incluida la catarata, que pueda interferir con la agudeza visual, con la valoración de la toxicidad o con la realización de las fotografías de fondo de ojo en el ojo de estudio. Los sujetos no deberán ser incluidos en el estudio si existen probabilidades de que requieran cirugía de cataratas en el ojo estudiado durante los 12 meses siguientes.
    .Presencia de otras causas de neovascularización coroidea, como la miopía patológica (equivalente esférico de -8 o más dioptrías, o bien longitud axial de 25mm o más), síndrome de histoplasmosis ocular, estrías angioides, desgarros coroideos o coroiditis multifocal.
    .Cualquier cirugía intraocular o láser térmico aplicado al interior del ojo dentro de los 3 meses previos a la inclusión en el estudio. Cualquier láser térmico previo aplicado a la zona macular, independientemente de su indicación.
    .Cualquier infección ocular o periocular durante las 12 semanas previas.
    .Antecedentes de cualquiera de las siguientes enfermedades o procedimientos en el ojo de estudio: Desprendimiento regmatógeno de la retina, vitrectomía de pars plana, cirugía filtrante (p.ej., trabeculectomía), implantación de un dispositivo de drenaje para el glaucoma, trasplante de córnea.
    .Irradiación terapéutica previa en la región del ojo en estudio.

    Criterios de exclusión generales
    .Cualquiera de las siguientes enfermedades o patologías de base:
    Diabetes mellitus (independientemente de los valores de HbA1c)
    HbA1c >/= 6,5%. Si el paciente no presenta signos ni síntomas de diabetes mellitus, podrá repetirse una sola vez la determinación de HbA1c.
    Si la HbA1c sigue siendo >/= 6,5% al repetir la determinación, el paciente deberá ser excluido del estudio.
    Si la HbA1c es <6,5% al repetir la determinación, podrá incluirse al paciente en el estudio.
    Antecedentes de otras enfermedades o trastornos metabólicos, o bien hallazgos en la exploración física o en los análisis de laboratorio que supongan una sospecha razonable de existencia de una patología o trastorno que contraindique el uso de un fármaco en investigación o que pueda afectar a la interpretación de los resultados del estudio, o bien exponer al sujeto a un elevado riesgo de complicaciones a causa del tratamiento.
    Antecedentes o evidencias de cardiopatía grave (p.ej., Clase Funcional III o IV de la NYHA - véase Apéndice 17.6), antecedentes o evidencias clínicas de angina inestable, síndrome coronario agudo, infarto de miocardio o revascularización coronaria durante los 6 meses anteriores, o bien de taquiarritmias ventriculares que requieran un tratamiento continuado.
    Ictus (dentro de los 12 meses anteriores a la inclusión en el estudio).
    Cualquier procedimiento de cirugía mayor dentro del mes anterior a la inclusión en el estudio.
    .Cualquier tratamiento con un fármaco en investigación, para cualquier patología, durante los 60 días previos a la aleatorización.
    .Alergias graves conocidas al contraste de fluoresceína utilizado en la angiografía (están permitidas las alergias leves susceptibles de tratamiento), o a los componentes o la formulación de FovistaTM o Lucentis®.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the Month 12 visit.
    El criterio principal de valoración de la eficacia es el cambio medio de la agudeza visual (letras de los optotipos ETDRS) en la visita del mes 12 respecto al valor basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following Month 12 visit
    Después de la visita del mes 12
    E.5.2Secondary end point(s)
    The proportion of subjects in each treatment group gaining 20 or more ETDRS letters from baseline at the Month 12 visit.
    The proportion of subjects in each treatment group gaining 25 or more ETDRS letters from baseline at the Month 12 visit.
    The proportion of subjects in each treatment group losing 5 or more ETDRS letters from baseline at the Month 12 visit.
    The mean change in visual acuity (ETDRS letters) from baseline at the Month 6 visit.
    .Porcentaje de sujetos que presentan una ganancia de 20 letras ETDRS o más en la visita del mes 12 respecto al valor basal en cada grupo de tratamiento.
    .Porcentaje de sujetos que presentan una ganancia de 25 letras ETDRS o más en la visita del mes 12 respecto al valor basal en cada grupo de tratamiento.
    .Porcentaje de sujetos que presentan una pérdida de 5 letras ETDRS o más en la visita del mes 12 respecto al valor basal en cada grupo de tratamiento.
    .Cambio en la agudeza visual (letras ETDRS) en la visita del mes 6 respecto al valor basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following Month 6 and 12 visit
    Después de la visita del 6 y 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 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 Yes
    E.8.1.7.1Other trial design description
    Fovista and sham administered by an unmasked 1st Investigator, 2nd Investigator blinded
    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 de Fovista asi como un vial vacío
    Fovista sham as an empty vial
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Argentina
    Australia
    Colombia
    Denmark
    France
    Germany
    Hungary
    Israel
    Spain
    Turkey
    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
    Last visit of the last subject
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.1.1In 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: 155
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 231
    F.4.2.2In the whole clinical trial 655
    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)
    Standard of care.
    Tratamiento habitual.
    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 Decision2014-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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