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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2005-001324-36
    Sponsor's Protocol Code Number:VERTA
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-03-13
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-001324-36
    A.3Full title of the trial
    ENSAIO CLÍNICO DE FASE IIIB, PROSPECTIVO, CONTROLADO, COM OCULTAÇÃO DUPLA, ALEATÓRIO COM GRUPOS PARALELOS E MULTICÊNTRICO PARA COMPARAR A SEGURANÇA E A EFICÁCIA DA TERAPIA FOTODINÂMICA COM VERTEPORFINA (TFDV) VERSUS A ASSOCIAÇÃO DE TFDV COM ACETATO DE TRIAMCINOLONA (TA) INTRAVÍTREA EM DOENTES COM NEOVASCULARIZAÇÃO COROIDEIA (NVC) SUBFOVEAL ASSOCIADA À DEGENERESCÊNCIA MACULAR RELACIONADA COM A IDADE (DMRI) (ESTUDO VERTA)
    A.3.2Name or abbreviated title of the trial where available
    ESTUDO VERTA
    A.4.1Sponsor's protocol code numberVERTA
    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 SponsorInstituto Oftalmológico de Alicante (VISSUM)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Kenacort A
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameKenacort-A
    D.3.2Product code Triamcinolona
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTriamcinolona acetónido
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4/20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Visudyne®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma S.A.S.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameVisudyne®
    D.3.2Product code Verteporfina
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVerteporfina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neovascularização coroideia (NVC) subfoveal associada à degenerescência macular relacionada com a idade (DMRI)
    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
    Determinar se a média da alteração da acuidade visual aos 12 meses relativamente à basal é diferente no grupo de doentes com TFDV combinada com TA 4mg, o grupo de doentes com TFDV combinada com TA 20mg e os tratados apenas com TFDV.
    E.2.2Secondary objectives of the trial
    -Determinar se a proporção de doentes com diminuição importante da acuidade visual (definido por perda ≥ 15 letras) aos 12 meses relativamente à basal é diferente no grupo de doentes com apenas TFDV versus os tratados com TFDV combinada com TA 4mg e os tratados com TFDV combinada com TA 20mg.
    -Determinar se a proporção de doentes com diminuição ligeira da acuidade visual (definida por perda < 15 letras) a cada 3 meses relativamente à basal é diferente no grupo de doentes com apenas TFDV versus os tratados com TFDV combinada com TA 4mg e os tratados com TFDV combinada com TA 20mg.
    -Determinar se a proporção de doentes com actividade da NVC subfoveal determinada mediante AGF a cada 3 meses (consultas aos 3, 6, 9 e 12 meses) relativamente à basal é diferente no grupo de doentes tratados com apenas TFDV versus os tratados com TFDV combinada com TA 4mg e os tratados com TFDV combinada com TA 20mg.
    -Avaliar a segurança do tratamento com TFDV, TFDV com TA 4mg, TFDV com TA 20mg.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Doentes:
    -idade igual ou superior a 50 anos.
    -diagnosticados mediante angiografia fluoresceínica de NVC subfoveal associada a DMAI.
    -acuidade visual no olho em estudo entre 73-34 letras mediante ETDRS (aproximadamente entre 20/40 e 20/320) e uma acuidade visual no olho contralateral igual ou superior a 20/800.
    -NVC de qualquer tipo no olho em estudo com as seguintes características determinadas por angiografia fluoresceínica: Evidência de NVC que se estenda debaixo do centro geométrico da zona avascular foveal. A área da NVC deve ocupar pelo menos 50% do total da lesão. Para cada tipo de lesão devem ser cumpridos os critérios seguintes:
    -Para as NVC predominantemente clássicas a lesão deve ter ≤5,400 mícron de diâmetro maior (DLM).
    -Para as minimamente clássicas e as ocultas sem componente clássico, a lesão deve ser menor ou igual a 4 MPS áreas de disco e ter uma evolução recente presumível, ao critério do investigador, e definida como a presença de pelo menos um dos seguintes critérios:Hemorragia associado à lesão na visita inicial, perda de acuidade visual durante os 3 meses anteriores definida como ≥ 5 letras (Equivalente ETDRS) como se determina pelo protocolo de refracção e medida do protocolo, um aumento ≥ 10% no DLM da lesão detectado mediante angiografia fluoresceínica nos 3 meses anteriores.
    Nas ocultas sem componente clássico, se a lesão for > 4 MPS áreas de disco, a MAVC deve ser de < 65 letras.
    - capazes de cumprir os requisitos do estudo e sem impedimentos para seguir as instruções durante os 12 meses do estudo.
    -Que após serem informados dos objectivos e das características do estudo, dêem o seu consentimento por escrito.
    E.4Principal exclusion criteria
    -Tto anterior com terapia fotodinâmica, radiação externa, fotocoagulação subfoveal focal com laser, cirurgia submacular e termoterapia transpupilar no olho em estudo.
    -Estrias angióides, síndrome de presumível histoplasmose ocular, miopia (superior a – 6 dioptrias) ou outras causas de NVC diferentes das associadas à DMRI.
    -Tto concomitante com terapia sistémica ou tópica ocular com corticoesteróides. Tto. concomitante crónico definido como múltiplas doses diárias tomadas durante 3 ou mais dias consecutivos em qualquer momento durante os 3 meses anteriores à selecção.
    -Cataratas que, a critério do investigador, possam evoluir.
    -Recebidos anteriormente outro tratamento anti-angiogénico (como por exemplo Sandostatin®, Ruboxistaurin, Pegaptanib sódico, Ranibizumab, etc.) durante os 6 meses anteriores à selecção.
    -Fibrose, hemorragia, descolamento do epitélio pigmentar da retina ou outras lesões hipofluorescentes que suponham mais de 50% da lesão.
    -Apresentem ou possam apresentar durante o estudo patologia concomitante ocular com comprometimento irreversível ou que a evolução possa comprometer a acuidade visual do olho em estudo, incluindo ambliopia, neuropatia óptica isquémica anterior, edema macular diabético clinicamente significativo, retinopatia diabética severa não proliferativa.
    -Glaucoma ou pressão intraocular ≥ 23 mmHg no olho em estudo.
    -História de hipertensão ocular induzida por corticóides.
    -Cirurgia intraocular durante os dois meses anteriores à selecção (incluindo a cirurgia de catarata e um mês para YAG) no olho em estudo.
    -Administração anterior de fármacos intravítreos (injecção ou implantação) no olho em estudo.
    -Hipersensibilidade conhecida à verteporfina ou ao acetato de triamcinolona ou que apresentem alguma das contra-indicações especificadas nas fichas técnicas dos fármacos em estudo.
    -Incapacidade para obter fotografias documentadas da NVC devido, por exemplo, à opacidade dos meios, a alergia à fluoresceína ou à perda do acesso venoso.
    -Estejam a participar ou tenham participado num ensaio clínico durante as 12 semanas anteriores à inclusão.
    -Porfiria ou outra hipersensibilidade conhecida às porfirinas
    Hepatopatia ou hepatite activa clínica significativa.
    -apresentem hipertensão arterial não controlada (PAS >180 mmHg e/ou PAD >100mmHg).
    -Mulheres em idade fértil que não utilizem métodos anticonceptivos eficazes, gestantes, com suspeita de gravidez ou em período de lactância.
    E.5 End points
    E.5.1Primary end point(s)
    Alteração média na acuidade visual, medida com ETDRS, no final do estudo (12 meses) relativamente à basal.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Injecção simulada
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 189
    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 Decision2006-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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