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    Summary
    EudraCT Number:2014-004579-22
    Sponsor's Protocol Code Number:150998-005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-31
    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 number2014-004579-22
    A.3Full title of the trial
    Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration
    Seguridad y eficacia de Abicipar Pegol (AGN-150998) en pacientes con degeneración macular neovascular asociada a la edad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration
    Estudio para determinar (averiguar) la seguridad y la eficacia de Abicipar Pegol (AGN-150998) en pacientes con degeneración macular neovascular asociada a la edad
    A.3.2Name or abbreviated title of the trial where available
    CEDAR
    A.4.1Sponsor's protocol code number150998-005
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number900834223
    B.5.5Fax number-
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameAbicipar pegol
    D.3.2Product code AGN-150998
    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 INNAbicipar Pegol
    D.3.9.2Current sponsor codeAGN-150998
    D.3.9.3Other descriptive nameAbicipar
    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 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®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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.3.9.3Other descriptive nameRANIBIZUMAB
    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
    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 placeboOcular 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 (AMD).
    Degeneración macular neovascular asociada a la edad (DMAE)
    E.1.1.1Medical condition in easily understood language
    Neovascular age-related macular degeneration (AMD).
    Degeneración macular neovascular asociada a la edad (DMAE)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and efficacy of abicipar compared with ranibizumab in treatment-naïve patients with
    neovascular age-related macular degeneration (AMD).
    Evaluar la seguridad y la eficacia de abicipar en comparación con ranibizumab en pacientes con degeneración macular neovascular asociada a la edad (DMAE) no tratados previamente
    E.2.2Secondary objectives of the trial
    Not Applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria
    1. Male or female patients, 50 years of age or older at the time of informed consent
    2. Patient has completed/signed an informed consent prior to conduct of any study-related procedures or examinations, is able to follow study instructions, and is likely to complete all required visits
    3. Patient has provided, at screening, written documentation in accordance with the relevant country and local privacy requirements (eg, Written Authorization for Use and Release of Health and Research Study Information and written Data Protection consent, as required by regional health authorities)

    Ocular Inclusion Criteria (Study Eye)
    4. Presence of active subfoveal and/or juxtafoveal CNV secondary to AMD with retinal fluid on optical coherence tomography (OCT) and/or fluorescein leakage under the fovea as assessed by the investigator at screening and confirmed by the central reading center
    prior to baseline (day 1)
    5. Area of the CNV lesion, including both classic and occult components, must be > 50% of the total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
    6. BCVA <= 73 and >= 24 letters (20/40 to 20/320 Snellen equivalents, respectively) at screening and at baseline (day 1, prior to treatment) visits
    7. Sufficiently clear ocular media and adequate pupil dilation to permit good quality photographic imaging

    Ocular Inclusion Criteria (Non-study Eye)
    8. BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (day 1), prior to treatment
    Criterios generales de inclusión

    1. Varón o mujer, de 50 años de edad o más en el momento de firmar el consentimiento informado
    2. El paciente rellena/firma un consentimiento informado con anterioridad a todo procedimiento o examen relacionado con el estudio, es capaz de seguir las instrucciones del estudio y es probable que acuda a todas las visitas requeridas
    3. El paciente ha proporcionado, en la selección, documentación escrita de acuerdo con los requisitos de privacidad locales y nacionales pertinentes (p. ej., autorización escrita para el uso y la divulgación de la información sanitaria y de investigación del estudio y consentimiento protección de datos, según lo requerido por las autoridades sanitarias regionales)

    Criterios de inclusión ocular (Ojo estudiado):
    4. Presencia de NVC subfoveal y/o yuxtafoveal activa derivada de la DMAE con líquido retiniano en la tomografía de coherencia óptica (TCO) y/o fuga de fluoresceína bajo la fóvea según lo evaluado por el investigador en la selección y confirmado por el centro de lectura central antes del momento inicial (día 1)
    5. El área de la lesión NVC, componentes clásicos y ocultos incluidos, debe ser > 50 % del área total de la lesión, según lo evaluado por el investigador en la selección y confirmado por el centro de lectura central antes del momento inicial (día 1)
    6. MAVC <= 73 y >= 24 letras (equivalencia Snellen: de 20/40 a 20/320, respectivamente) en las visitas de selección y del momento inicial (día 1, previo al tratamiento)
    7. Medios oculares suficientemente transparentes y dilatación adecuada de las pupilas para permitir la obtención de imágenes fotográficas de buena calidad
    Criterios de Inlusión ocular (Ojo no estudiado):
    8. Una MAVC de 34 letras (equivalencia Snellen: 20/200) o mejor en el momento inicial (día 1), previo al tratamiento
    E.4Principal exclusion criteria
    General Exclusion Criteria
    1. Females who are pregnant, nursing, planning a pregnancy during the study, or who are of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study. A pregnancy test administered to women of childbearing potential at the baseline visit (day 1, prior to treatment) must be negative for the patient to receive study medication
    2. History or current evidence of hypersensitivity to any components of the study medication or clinically relevant sensitivity to fluorescein, as assessed by the investigator at screening
    3. History or current evidence of hypersensitivity, allergy, or anaphylactic reaction to iodine as assessed by the investigator at screening
    4. Participation in any investigational device study within 30 days, or participation in any investigational drug study within 30 days or 5 half-lives of the respective investigational drug (whichever is longer) prior to baseline (day 1)
    5. History or current evidence of a medical condition (including physical examination finding, or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of study medication, adherence to the scheduled study visits, safe participation in the study or confound study results (eg, metabolic
    dysfunction, uncontrolled hypertension, autoimmune disease, infection, inflammatory condition, advanced coronary artery disease, cerebral vascular disease, other unstable or progressive cardiovascular or pulmonary condition, Parkinson's disease, liver or renal failure, cancer, or dementia)
    6. Treatment with systemic anti-VEGF medication (eg, bevacizumab, ziv-aflibercept) or VEGF-receptor inhibitor (eg, sunitinib, sorafenib, pazopanib) within 3 months prior to baseline (day 1)
    7. Use of systemic (eg, oral, intravenous, intramuscular, rectal, or extensive dermal [> 20% total body surface area]) corticosteroids within 5 days prior to baseline (day 1)

    Ocular Exclusion Criteria (Either Eye)
    8. Active ocular/intraocular infection at baseline (day 1)
    9. History of recurrent or currently active ocular/intraocular inflammation (eg, uveitis) at baseline (day 1)
    10. History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or any retinal vascular disease other than AMD at screening

    Ocular Exclusion Criteria (Study Eye)
    11. Presence of CNV other than AMD at screening, eg, pathologic myopia, ocular histoplasmosis, and angioid streaks
    12. Spherical equivalent of the refractive error of -8 diopters of myopia or worse (prior to cataract or refractive surgery) at screening
    13. Any active iris neovascularization, or current evidence of vitreous hemorrhage, or retinal detachment (considered by the investigator to significantly affect central vision) prior to baseline (day 1)
    14. Previous use of verteporfin PDT or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region of the study eye
    15. Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD, approved or investigational, except dietary supplements or vitamins
    16. Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD
    17. Treatment with ocular corticosteroid injections or implants (eg, by subconjunctival, periocular, or intravitreal routes of administration) within 6 months prior to baseline (day 1), or with fluocinolone acetonide implant (Iluvien?) within 36 months prior to
    baseline (day 1)
    18. Previous or concurrent laser treatment for macular drusen
    19. Total lesion size > 12 disc area (DA) (30.5 mm2 including blood, neovascularization, and fibrosis) as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
    20. Presence of a retinal pigment epithelium (RPE) tear or rip lesion involving the macula as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
    21. Structural damage to the center of the macula that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the RPE, and retinal fibrosis/scarring, as assessed by the investigator at screening and confirmed by the
    central reading center prior to baseline (day 1)
    22. Macular scar or fibrosis, making up > 50% of total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)

    For the remaining exclusion criteria, please see protocol pages 23 and 24.
    Criterios generales de exclusión
    1. Mujeres embarazadas, lactantes o que estén buscando un embarazo durante el estudio; mujeres en edad fértil que no utilicen métodos anticonceptivos fiables y/o no deseen utilizar métodos anticonceptivos fiables durante su participación en el estudio.
    2. Antecedentes o indicios actuales de hipersensibilidad a cualquier componente de la medicación del estudio o sensibilidad clínicamente significativa a la fluoresceína, según lo evaluado por el investigador en la selección
    3. Antecedentes o indicios actuales de hipersensibilidad, alergia o reacción anafiláctica al yodo, según lo evaluado por el investigador en la selección
    4. Participación en cualquier estudio de dispositivos en investigación en los 30 días previos o participación en cualquier estudio de fármacos en investigación en los 30 días previos o en 5 semividas del fármaco en investigación respectivo (el valor que sea superior) con anterioridad al momento inicial (día 1)
    5. Antecedentes o indicios actuales de una afección médica (incluidos los hallazgos en el examen físico o en el laboratorio clínico) que puedan, en opinión del investigador, impedir la administración segura de la medicación del estudio, la adherencia a las visitas programadas del estudio o la participación segura en el estudio, o producir una confusión en los resultados del estudio
    6. Tratamiento con medicación sistémica contra el FCEV (p. ej., bevacizumab, ziv-aflibercept) o inhibidores de los receptores del FCEV (p. ej., sunitinib, sorafenib, pazopanib) en los 3 meses previos al momento inicial (día 1)
    7. Uso de corticosteroides sistémicos (p. ej., orales, intravenosos, intramusculares, rectales o tópicos de uso extenso [> 20 % de la superficie corporal total]) en los 5 días previos al momento inicial (día 1)
    Criterios oculares de exclusión (ambos ojos)
    8. Infección ocular/intraocular activa en el momento inicial (día 1)
    9. Antecedentes de inflamación ocular/intraocular recurrente o actualmente activa (p. ej. uveítis) en el momento inicial (día 1)
    10. Antecedentes o indicios clínicos de retinopatía diabética, edema macular diabético (EMD) o cualquier enfermedad vascular retiniana que no sea la DMAE en la selección
    Criterios oculares de exclusión (ojo estudiado)
    11. Presencia de NVC que no sea DMAE en la selección, p. ej. miopía patológica, histoplasmosis ocular y estrías angioides
    12. Equivalente esférico del error refractivo de -8 dioptrías de miopía o peor (antes de la cirugía de cataratas o refractiva) en la selección
    13. Toda neovascularización activa del iris o indicios actuales de hemorragia vítrea o de desprendimiento de retina (que el investigador considere que afectan significativamente a la visión central) antes del momento inicial (día 1)
    14. Uso previo de terapia fotodinámica con verteporfina u otra terapia ocular antiangiogénica (p. ej., aflibercept, bevacizumab, ranibizumab, pegaptanib), aprobada o en investigación, para el tratamiento de la DMAE neovascular, o radiación terapéutica previa en la región del ojo estudiado
    15. Todo tratamiento sistémico u ocular (cirugía incluida) previo o actual para la DMAE neovascular, aprobado o en investigación, excepto vitaminas o suplementos dietéticos
    16. Uso previo de agentes oculares contra el FCEV para enfermedades oculares neovasculares que no sean DMAE
    17. Tratamiento mediante implantes o inyecciones oculares de corticosteroides (p. ej., por administración subconjuntival, periocular o intravítrea) en los 6 meses previos al momento inicial (día 1), o mediante implantes de acetónido de fluocinolona (Iluvien?) en los 36 meses previos al momento inicial (día 1)
    18. Tratamiento previo o concurrente con láser para drusas maculares
    19. Tamaño total de la lesión > 12 áreas de disco (AD) (30,5 mm2 incluyendo sangre, neovascularización y fibrosis), según lo evaluado por el investigador en la selección y confirmado por el centro de lectura central antes del momento inicial (día 1)
    20. Presencia de un desgarro o una lesión del epitelio pigmentario retiniano (EPR) que afecte a la mácula, según lo evaluado por el investigador en la selección y confirmado por el centro de lectura central antes del momento inicial (día 1)
    21. Daños estructurales del centro de la mácula con probabilidad de impedir la mejora de la MAVC tras la remisión del edema macular, incluida la atrofia del EPR, y fibrosis/cicatrización retiniana, según lo evaluado por el investigador en la selección y confirmado por el centro de lectura central antes del momento inicial (día 1)
    22. Fibrosis macular o cicatriz responsable de > 50 % del área total de la lesión, según lo evaluado por el investigador en la selección y confirmado por el centro de lectura central antes del momento inicial (día 1)

    Para los demás criterios de exclusión, remítanse al protocolo páginas 23 y 24
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with stable vision (i.e. patients who lose fewer than 15 letters in BCVA) from baseline at week 52.
    Proporción de pacientes con visión estable (es decir, pacientes que pierdan menos de 15 letras en la MAVC) respecto al momento inicial en la semana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52.
    Semana 52
    E.5.2Secondary end point(s)
    - Mean change from baseline in BCVA at week 52
    - Mean change from baseline in CRT as assessed with SD-OCT and quantified by the central reading center at week 52
    - Proportion of patients with a gain of 15 or more ETDRS letters in BCVA from baseline at week 52
    - Mean change from baseline in NEI-VFQ-25 composite score at week 52
    - Cambio medio de la MAVC respecto al momento inicial en la semana 52
    - Cambio medio del ERC respecto al momento inicial según lo evaluado por TCO-DE y cuantificado por el centro de lectura central en la semana 52
    - Proporción de pacientes con una mejora de 15 o más letras en el ETTRD en la MAVC respecto al momento inicial en la semana 52
    - Cambio medio en la puntuación compuesta del NEI-VFQ-25 respecto al momento inicial en la semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52.
    Semana 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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    inmunogenicidad
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Austria
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Hong Kong
    Israel
    Korea, Republic of
    Latvia
    New Zealand
    Philippines
    Portugal
    Singapore
    Spain
    Switzerland
    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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 308
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 618
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with poor vision
    Pacientes con mala visión
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 926
    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)
    Following their exit from the study patients will discuss with their study doctor the most appropriate standard of care treatment for their condition for them to move onto.
    Después de la salida del estudio los pacientes hablarán con el médico del estudio sobre el tratamiento habitual más adecuado que se les puede asignar para su enfermedad
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-16
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