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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-021291-29
    Sponsor's Protocol Code Number:FOV2304/CLIN/201/P
    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:2011-01-27
    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 number2010-021291-29
    A.3Full title of the trial
    Estudio de 6 meses de fase II con doble enmascaramiento, multicéntrico, aleatorizado, controlado con placebo, de grupos paralelos para determinar la seguridad y la eficacia de la administración tópica de dos concentraciones de FOV2304 (1% y 2%) dos veces al día para el tratamiento del edema macular de importancia clínica con afectación central asociado a retinopatía diabética
    A.4.1Sponsor's protocol code numberFOV2304/CLIN/201/P
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFovea Pharmaceuticals SA
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameFOV2304/SOL2/1%
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFV-60135-02
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameFOV2304/SOL2/2%
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFV-60135-02
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboEye drops, solution
    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
    Clinically significant diabetic macular edema in at least one eye involving the center of the macula ---Edema macular diabético clínicamente significativo en al menos un ojo y que afecte al centro de la mácula
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es determinar si las concentraciones de FOV2304 al 1 % dos veces al día o al 2 % dos veces al día son más eficaces que el placebo en la reducción del grosor medio de la retina central después de 12 semanas de tratamiento en pacientes con EMD. ---The primary objective of the study is to determine whether concentrations of FOV2304 at 1% BID or 2% BID is more effective than placebo in decreasing mean central retinal thickness following twelve weeks of treatment for patients with DME
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio son evaluar los efectos de FOV2304 (al 1 % y al 2 % dos veces al día) en comparación con placebo sobre la agudeza visual, el grosor retiniano y el volumen macular después de 12 semanas de tratamiento y después de otras 12 semanas de seguimiento y la necesidad de tratamiento de rescate durante el período de seguimiento de la seguridad, y evaluar la seguridad, la tolerabilidad y la PK de FOV2304 en el tratamiento de pacientes con EMD. ---The secondary objectives of the study are to estimate the effects of FOV2304 (1% and 2% BID) compared with placebo on visual acuity, retinal thickness and macular volume following twelve weeks treatment and after a further twelve weeks of follow-up, the requirement for rescue therapy during the safety follow-up period and to assess the safety, tolerability, and PK of FOV2304 in the treatment of patients with DME.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes de ambos sexos, de 18 años de edad como mínimo. 2. Obtención del consentimiento informado firmado por escrito. 3. Diagnóstico de diabetes mellitus. 4. El paciente debe ser capaz de autoadministrarse el fármaco del estudio. 5. Edema macular diabético clínicamente significativo en un ojo como mínimo (?ojo del estudio?) que afecte al centro de la mácula. 7. Retinopatía diabética no proliferativa leve a intensa 8. Puntuación de la mejor agudeza visual corregida (MAVC) ?8805; 34 letras y < 80 letras en el ojo del estudio. 11. Las mujeres deberán llevar al menos un año en posmenopausia, estar esterilizadas quirúrgicamente o utilizar dos métodos anticonceptivos médicamente aceptables. Las mujeres en edad fértil deberán dar resultado negativo en una prueba de embarazo en orina en la selección y utilizar dos métodos anticonceptivos de elevada eficacia a lo largo del estudio. 12. Los varones cuyas parejas se encuentren en edad fértil deberán comprometerse a utilizar al menos un método anticonceptivo de elevada eficacia durante todo el estudio.
    E.4Principal exclusion criteria
    1.Cualquier trastorno ocular en el ojo del estudio que, en opinión del investigador, impida la mejoría de la agudeza visual (como, por ejemplo, isquemia macular intensa, atrofia de la fóvea, anomalías pigmentarias, exudados duros subfoveales densos, trastornos no retinianos). 2. Retinopatía diabética proliferativa. 3. Antecedentes de fotocoagulación panretiniana difusa (PRP) en los 4 meses previos a la selección, y necesidad prevista de PRP en los 3 meses siguientes a la aleatorización. 4. Presencia de cualquier otro proceso que podría contribuir al edema macular. a.Presencia de oclusión de ramas de venas retinianas, oclusión de la vena central de la retina, uveítis, edema macular cistoide pseudofáquico, o cualquier otro trastorno en el ojo del estudio que pudiera contribuir al edema macular. b. Presencia de una membrana epirretiniana, tracción hialoidal posterior o tracción vitreomacular en el ojo del estudio que, en opinión del investigador o del centro de interpretación, es la causa principal del edema macular, o es lo bastante intensa para impedir que mejore de la agudeza visual a pesar de la reducción del edema macular. 5. Neovascularización activa de la retina o de la papila óptica, rubeosis iridiana, neovascularización coroidea activa o antecedentes de la misma. 6. Antecedentes de vitrectomía de la pars plana en cualquier momento, cirugía intraocular en los 90 días previos a la selección. 7. Antecedentes de uso de corticosteroides (distintos del acetónido de triamcinolona) inyectables, intravítreos o de depósito periocular en los 3 meses previos a la visita de selección. 8. Pacientes que hayan recibido previamente acetónido de triamcinolona 9. Pacientes que hayan recibido previamente tratamiento contra el factor de crecimiento del endotelio vascular (VEGF)
    a. Anti-VEGF intravítreo en los 3 meses previos a la visita de selección.
    b. Anti-VEGF sistémico en los 3 meses previos a la visita de selección.10. Glaucoma no controlado o glaucoma tratado con dos o más fármacos. 11. Presión intraocular (PIO) ? 25 mm Hg en la tonometría por aplanación en la visita de selección.12. Afaquia o lente intraocular en la cámara anterior en el ojo del estudio. 13. Pacientes cuya puntuación basal acumulada de la tinción de la córnea con fluoresceína (es decir, la suma de las puntuaciones de las 5 regiones corneales) en el ojo del estudio sea ? 5, o pacientes cuya puntuación basal acumulada de la tinción de la córnea con fluoresceína en una sola región en el ojo de estudio sea ? 3. 14. Cualquier infección ocular activa; antecedentes de infecciones crónicas o recurrentes o de inflamación en el ojo de estudio. 15. Antecedentes de infección herpética en uno de los ojos. 16. Antecedentes de enfermedad/intervención quirúrgica corneal. 17. Uso de lentes de contacto. Enfermedades sistémicas: 18. Enfermedad sistémica no controlada. 19. Diabetes mellitus mal controlada. 20. Función renal deficiente. 21. Inicio/cambio de tratamiento farmacológico de la diabetes mellitus o la hipertensión en los 4 previos a la selección, o cambio previsto en los 4 meses siguientes a la inclusión en el estudio. 22. Hipertensión arterial mal controlada. 23. Uso de esteroides sistémicos durante el mes anterior a la visita de selección o previsión de utilizarlos en cualquier momento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de este estudio es evaluar la variación con respecto al valor basal del GCR, determinada por logTCO en la semana 12. ----The primary endpoint of this study is to evaluate the change from baseline of central retinal thickness as determined by logOCT at Week 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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 EEA40
    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
    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
    NA
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 216
    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 Decision2011-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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