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    Summary
    EudraCT Number:2017-003899-31
    Sponsor's Protocol Code Number:DBC-AMD-001-D
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003899-31
    A.3Full title of the trial
    International, multicenter, randomised, blind, sham-controlled, 2x2 cross over phase III clinical trial to assess the efficacy and security of an intravitreal injection of Etamsylate in the improvement of visual acuity of patients with dry age-related macular degeneration.
    Jericho-D, studio clinico di fase III, con disegno crossover 2x2, controllato con iniezione simulata, in cieco, randomizzato, multicentrico, internazionale, per valutare l’efficacia e la sicurezza di un’iniezione intravitreale di etamsilato nel miglioramento dell’acuità visiva, in pazienti con degenerazione maculare senile secca.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International, multicenter, randomised, blind, sham-controlled, 2x2 cross over phase III clinical trial to assess the efficacy and security of an intravitreal injection of Etamsylate in the improvement of visual acuity of patients with dry age-related macular degeneration.
    Jericho-D, studio clinico di fase III, con disegno crossover 2x2, controllato con iniezione simulata, in cieco, randomizzato, multicentrico, internazionale, per valutare l’efficacia e la sicurezza di un’iniezione intravitreale di etamsilato nel miglioramento dell’acuità visiva, in pazienti con degenerazione maculare senile secca.
    A.3.2Name or abbreviated title of the trial where available
    JERICHO-D
    JERICHO-D
    A.4.1Sponsor's protocol code numberDBC-AMD-001-D
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorDOBECURE S.L.
    B.1.3.4CountrySpain
    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 organisationLeon Research S.L.
    B.5.2Functional name of contact pointCarla d'Altilia
    B.5.3 Address:
    B.5.3.1Street AddressVia Enrico Fermi, 3
    B.5.3.2Town/ cityCordenons (PN)
    B.5.3.3Post code33084
    B.5.3.4CountryItaly
    B.5.4Telephone number00393345967636
    B.5.5Fax number0039987216243
    B.5.6E-mailcdaltilia@leonresearch.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dicynone
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDicynone
    D.3.2Product code [020917023]
    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 INNEtamsilato
    D.3.9.1CAS number 2624-44-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameEtamsylate
    D.3.9.4EV Substance CodeSUB11943MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    age-related macular degeneration (AMD) is a serious disease in terms of the incapacity it may produce in patients who suffer from it, accompanied by a consequent deterioration in their quality of life. Nowadays, there are only authorised treatments for exudative (wet) AMD. These treatments target the vascular endothelial growth factor (VEGF) aiming to block it.Nowadays, there is no treatment for dry AMD.
    la degenerazione maculare senile (DMS) è una malattia grave per l’inabilità che può determinare nei pazienti affetti, e per il deterioramento della qualità della vita che ne consegue. Attualmente sono disponibili solo trattamenti autorizzati per la DMS essudativa (umida). Questi trattamenti agiscono sul fattore di crescita dell’endotelio vascolare (VEGF), con l’obiettivo di bloccarlo. Non esiste attualmente alcun trattamento per la DMS secca
    E.1.1.1Medical condition in easily understood language
    Aged related macula degeneration (AMD) is a serious disease in terms of the incapacity it may produce in patients who suffer from it, accompanied by a consequent deterioration in their quality of life
    la degenerazione maculare senile (DMS) è una malattia grave per l’inabilità che può determinare nei pazienti affetti, e per il deterioramento della qualità della vita che ne consegue.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025409
    E.1.2Term Macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy after 90 days of a single intravitreal injection of Etamsylate in the improvement of visual acuity in patients diagnosed with dry AMD.
    Valutare l’efficacia dopo 90 giorni da una singola iniezione intravitreale di etamsilato nel miglioramento dell’acuità visiva in pazienti con diagnosi di DMS secca.
    E.2.2Secondary objectives of the trial
    To assess the efficacy after 90 days of a single intravitreal injection of Etamsylate in structural changes of the retina associated to the AMD evaluating the number, localization, areaand volume of drusen.
    For those patients suffering from the most advanced form of the disease (geographical atrophy) to assess the changes in percentage of the area affected by geographical atrophy.
    To assess the efficacy after 90 and 180 days of a single intravitreal injection of Etamsylate in patient’s quality of life.
    To compare the results obtained in this clinical trial with an historic control group to assess the long-term efficacy of a single injection of intravitreal etamsylate.
    Valutare l’efficacia dopo 90 giorni da una singola iniezione intravitreale di etamsilato nelle alterazioni strutturali della retina associate alla DMS, valutando il numero, la localizzazione, l’area e il volume delle drusen.
    Per i pazienti affetti dalla forma più avanzata della malattia (atrofia geografica), valutare le variazioni nella percentuale dell’area interessata dall’atrofia geografica.
    Valutare l’efficacia dopo 90 e 180 giorni da una singola iniezione intravitreale di etamsilato nella qualità della vita del paziente.
    Confrontare i risultati ottenuti in questo studio clinico con un gruppo di controllo storico, per valutare l’efficacia a lungo termine di una singola iniezione di etamsilato intravitreale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients, aged =18 years, males or females.
    Diagnosis of dry AMD
    Patients with best corrected visual acuity (BCVA) between 20/25 and 20/320, measured by ETDRS optotype (Early Treatment Diabetic Retinopathy Study)
    Patients with the capacity and disposition to follow the study protocol and procedures and that grant their informed consent in writing (signed and dated), accepting voluntarily to participate in the trial
    Pazienti adulti, di età =18 anni, maschi o femmine.
    Diagnosi di DMS secca.
    Pazienti con migliore acuità visiva corretta (BCVA) compresa tra 20/25 e 20/320, misurata mediante ottotipo ETDRS (Early Treatment Diabetic Retinopathy Study, studio sul trattamento precoce della retinopatia diabetica).
    Pazienti con capacità e volontà di seguire il protocollo e le procedure dello studio e che concedono il consenso informato scritto (firmato e datato), accettando volontariamente di partecipare allo studio.
    E.4Principal exclusion criteria
    Patients with grade 5 AMD in one or both eyes.
    Patients with any concomitant ocular disease that, under investigator’s judgement, could influence the development, evaluation or assessment of the AMD, such as glaucoma, permanent structural damage in the centre of the fovea, Geographic parafoveolar atrophy, Polypoid choroidal vasculopathy etc.
    Patients with any concomitant disease that, under investigator’s judgement, could influence (the disease itself or its treatment) the development, evaluation or assessment of the AMD, such as diabetes mellitus with ocular affectation, current or active systemic infection, any ocular infection, psychiatric diseases, social situation that may affect study protocol compliance etc.
    • Patients treated with any intravitreal anti-VEGF agent within the last month prior to study randomisation entry
    • Pregnant or breastfeeding women (urine pregnancy test to be performed for those patients of childbearing potential patients)
    Pazienti con DMS di grado 5 in uno o entrambi gli occhi.
    Pazienti con qualsiasi malattia oculare concomitante che, a giudizio dello Sperimentatore, potrebbe influenzare lo sviluppo, l’analisi o la valutazione della DMS, come glaucoma, danni strutturali permanenti nel centro della fovea, atrofia parafoveolare geografica, vasculopatia coroidale polipoide e così via.
    Pazienti con qualsiasi malattia concomitante che, a giudizio dello Sperimentatore, potrebbe influenzare (la malattia stessa o il relativo trattamento) lo sviluppo, l’analisi o la valutazione della DMS, come diabete mellito associato a malattia oculare, infezione sistemica corrente o attiva, qualsiasi infezione oculare, malattie psichiatriche, situazione sociale che può compromettere la compliance al protocollo dello studio e così via.
    Pazienti trattati con qualsiasi agente anti-VEGF intravitreale nell’ultimo mese prima della randomizzazione dello studio.
    Donne in gravidanza o allattamento (test di gravidanza urinario da eseguire nelle pazienti in età fertile).
    E.5 End points
    E.5.1Primary end point(s)
    The trial’s primary endpoint is, for each subject, the difference in number of letters read in the ETDRS optotype between the baseline values and after 90 and 180 days of a single intravitreal injection of Etamsylate expressed in in negative decimal logarithmic units of the Minimum Angle Resolution (logMAR).
    L’endpoint primario dello studio è, per ogni soggetto, la differenza nel numero di lettere lette nell’ottotipo ETDRS tra i valori basali e quelli registrati dopo 90 e 180 giorni da una singola iniezione intravitreale di etamsilato, espressa in unità logaritmiche decimali negative della minima risoluzione angolare (logMAR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 90 and 180 days from the baseline
    Dopo 90 e 180 giorni dalla visita basale
    E.5.2Secondary end point(s)
    Evolution from baseline at 90 and 180 days after etamsylate intravitreal injection of corrected visual acuity assessed by ETDRS optotype and expressed in in negative decimal logarithmic units of the Minimum Angle Resolution (logMAR) equivalent to the number of letters accurately read.
    Evolution from the baseline at 90 and 180 days after Etamsylate intravitreal injection of the number of letters read correctly (counted from the upper left corner) in the ETDRS optotype.
    Percentage of patients showing an improvement of the best-corrected visual acuity assessed with ETDRS.
    Evolution of the thickness of the central part of the macula measured by OCT.
    Evolution of the number of targeted areas of retinal pigment epithelium disappearance measured by OCT.
    Evolution of the number, location, area and volume of drusen measured by OCT and colour retinography.
    In those patients with the most advanced form of AMD (presence of geographical atrophy), the percentage of increase or decrease of the geographical atrophy area.
    Evolution of patient’s quality of life measured by Visual Function Questionnaire of National Eye Institute (VFQ-25) and EuroQol five dimensions-five levels questionnaire (EQ-5D-5L).
    Evolution compared with non-concurrent control group of corrected visual acuity assessed by ETDRS optotype. This group will include patients treated with any treatment alternatives, standard of care and observation.
    Evoluzione rispetto al gruppo di controllo non simultaneo nell’acuità visiva corretta valutata mediante ottotipo ETDRS. Questo gruppo includerà pazienti trattati con tutti i tipi di alternativa terapeutica, standard di cura e osservazione.
    Evoluzione dal basale a 90 e 180 giorni dopo l’iniezione intravitreale di etamsilato nell’acuità visiva corretta valutata mediante l’ottotipo ETDRS, ed espressa in unità logaritmiche decimali negative della minima risoluzione angolare (logMAR), equivalente al numero di lettere lette con accuratezza.
    Evoluzione dal basale a 90 e 180 giorni dopo l’iniezione intravitreale di etamsilato nel numero di lettere lette correttamente (contate dall’angolo superiore sinistro) nell’ottotipo ETDRS.
    Percentuale di pazienti che mostrano un miglioramento della migliore acuità visiva corretta valutata mediante ETDRS.
    Evoluzione nello spessore della parte centrale della macula misurata mediante TCO.
    Evoluzione nel numero di aree interessate dalla sparizione dell’epitelio pigmentato retinico misurate mediante TCO.
    Evoluzione in termini di numero, posizione, area e volume delle drusen, misurata mediante TCO e retinografia a colori.
    Nei pazienti con la forma più avanzata di DMS (presenza di atrofia geografica), la percentuale di aumento o riduzione dell’area dell’atrofia geografica.
    Evoluzione della qualità della vita del paziente, misurata mediante il Visual Function Questionnaire (questionario della funzione visiva) del National Eye Institute (VFQ-25) e il questionario EuroQol in cinque dimensioni e cinque livelli (EQ-5D-5L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 90 and 180 days from the baseline
    Dopo 90 e 180 giorni dalla visita basale
    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 No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Il trattamento con iniezione simulata imiterà la somministrazione di etamsilato a tutti i livelli (p
    Fingered Treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    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
    LVLS
    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 days18
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days18
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    None
    Nessuno
    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 Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
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