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    Summary
    EudraCT Number:2007-003042-15
    Sponsor's Protocol Code Number:ACU301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-12
    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 number2007-003042-15
    A.3Full title of the trial
    A Phase 3, randomized, double-masked, parallel-assignment study of intravitreal bevasiranib sodium administered every 8 or 12 weeks as maintenance therapy following three injections of Lucentis compared with Lucentis monotherapy every 4 weeks in patients with Exudative Age-Related Macular Degeneration (AMD)
    A Phase 3, randomized, double-masked, parallel-assignment study of intravitreal bevasiranib sodium administered every 8 or 12 weeks as maintenance therapy following three injections of Lucentis compared with Lucentis monotherapy every 4 weeks in patients with Exudative Age-Related Macular Degeneration (AMD)
    A.4.1Sponsor's protocol code numberACU301
    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 SponsorOPKO HEALTH INC
    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 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 namebevasiranib sodium
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 FARMA SpA
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 347396-82-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    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
    Exudative Age-Related Macular Degeneration
    Degenerazione Maculare Senile Essudativa
    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 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 evaluate efficacy of bevasiranib sodium as maintenance therapy in patients with Exudative Age-Related Macular Degeneration (AMD)after initial VEGF antagonist therapy with 3 doses of Lucentis
    Valutare l'efficacia di bevasiranib sodico come terapia di mantenimento per la Degenerazione Maculare Senile dopo l'inizio di una terapia anti VEGF con tre dosi di Lucentis.
    E.2.2Secondary objectives of the trial
    The proportion of patients who have a successful visual acuity outcome at week 60 and had no need for rescue therapy in the first year after treatment
    Valutare la proporzione di pazienti con esito positivo per quanto riguarda l'acuita' visiva alla settimana 60 e che non necessitano di terapia di sostegno nel primo anno dopo l'inizio del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have predominantly classic, minimally classic, or occult
    with no classic lesions, secondary to AMD, with a total lesion size
    (including blood, scarring and neovascularization) of < 12 total disc areas (30.48 mm2);
    2. Patients must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye;
    3. Occult with no classic lesions must have evidence of presumed recent
    disease progression defined as:
    a. The presence of subretinal hemorrhage OR
    b. Loss of > 1 line of VA during the past 12 weeks OR
    c. FA documented lesion growth by _ 10% during the past 12 weeks;
    4. Patients must be age 50 or older;
    5. Patient must sign and retain a copy of the written informed consent form;
    6. Patients must be willing and able to return for scheduled follow-up
    examinations for two years; and
    7. Women must be post-menopausal 1 year, or surgically sterilized. If not, a negative serum pregnancy test is required within 14 days of randomization.
    Maschi e femmine, eta' minima 50 anni, con lesioni prevalentemente classiche, minimamente classiche o occulte senza classiche secondarie a Degenerazione Maculare Senile e miglior acuita' visiva corretta secondo EDTRS da 69 a 24 lettere (20/40 a 20/320 equivalenti Snellen)
    E.4Principal exclusion criteria
    1. Patients who have been previously treated for AMD in the study eye with
    any agent except vitamins and/or minerals;
    2. Patients with concomitant disease in the study eye, including uveitis,
    presence of pigment epithelial tears or rips, acute ocular or periocular
    infection;
    3. Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22mmHg in the study eye despite adequate treatment with medication;
    4. Patients with any retinal vasculopathies, including diabetic retinopathy,retinal vein occlusions, etc. in the study eye;
    5. Patients with any subfoveal scarring, atrophy, or hemorrhage > 500&#956;m in the study eye;
    6. Patients whose CNV lesion in the study eye contains more than 25%
    scarring and/or fibrosis;
    7. Patients with inadequate papillary dilation or significant media opacities in the study eye, which may interfere with visual acuity or the evaluation of the posterior segment, including cataract, which is likely to require surgical intervention within the 100 week active study period;
    8. Patients who present with choroidal neovascularlization due to causes
    other than AMD, including ocular Histoplasmosis syndrome, angioid
    streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia
    (spherical equivalent > 8 Diopters or axial length > 25mm);
    9. Patients who have undergone any intraocular surgery of the study eye
    within 12 weeks prior to the screening visit;
    10. Patients who have undergone any extrafoveal/juxtafoveal laser treatment
    of the study eye within two weeks prior to the screening visit;
    11. Patients with previous posterior vitrectomy of the study eye;
    12. Patients with known serious allergies to fluorescein dye, not amenable to treatment with diphenhydramine;
    13. Patients who underwent previous radiation therapy to the head or neck in the region of the study eye;
    14. Patients who received treatment with any investigational drug within 4
    weeks prior to the screening visit;
    15. Patients with an intravitreal device or drug implant in the study eye;
    16. Patients with any other condition, which in the judgment of the
    investigator would prevent the patient from completing the study;
    17. Premenopausal women not using adequate contraception.
    I pazienti non devono mai essere stati trattati per la DMS, il che esclude precedente uso di Avastin/Lucentis, Macugen e qualsiasi altro prodotto anti VGEF, trattamenti con steroidi, PDT, trattamenti con radiazioni, qualsiasi trattamento sperimentale per la DMS. I pazienti non possono essere stati sottoposti a nessuna chirurgia intraoculare entro 12 settimane dallo screening. Una precedente vitrectomia posteriore nell'occhio in studio non e' ammessa.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision)
    La proporzione di pazienti in ciascun gruppo alla settimana 60 con esito positivo per quanto riguarda l'acuita' visiva (definito come prevenzione della perdita di 3 o piu' linee nella visione)
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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
    La conclusione della sperimentazione si identifica con la Visita di Chiusura dell'ultimo centro attivo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 250
    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)
    Il protocollo non prevede ulteriori programmi di trattamento
    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 Decision2008-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-05-04
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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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