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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:2007-003042-15
    Sponsor's Protocol Code Number:ACU301
    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:2007-07-27
    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 ConcernedPortugal - INFARMED
    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.3.2Name or abbreviated title of the trial where available
    COBALT
    A.4.1Sponsor's protocol code numberACU301
    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 SponsorOpko Health, Incorporated
    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.3.4Pharmaceutical form Solution 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 INNBevasiranib Sodium
    D.3.9.3Other descriptive nameBevasiranib Sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic double stranded RNA (dsRNA) oligonucleotide; Small Interfering RNA (siRNA).
    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 Limited
    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 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 INNRanibizumab
    D.3.9.1CAS number 347396-82-1
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-(human vascular endothelial growth factor)
    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) 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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with subfoveal choroidal neovascularization associated with Age-Related Macular Degeneration
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this Phase 3, multi-center, randomized, double-masked, controlled, study is to show that after initial VEGF antagonist therapy with 3 doses of Lucentis®, maintenance therapy with bevasiranib (2.5 mg) administered at two dosing regimens (8 weeks apart and 12 weeks apart) is not inferior to continued treatment with Lucentis® every 4 weeks with regard to safety and efficacy.

    o Efficacy endpoints:

    - Primary efficacy measure: The proportion of subjects at 60 weeks in each group with a successful visual acuity outcome.

    o Safety endpoints:

    - The incidence of injection-related complications.

    - Frequency of severe loss of visual acuity (6 or more lines) from baseline to week 60.

    - Rate of serious ocular adverse events.

    - Incidence of increased intraocular pressure requiring medical or surgical intervention.

    - All adverse events reported, whether deemed related to treatment or not.
    E.2.2Secondary objectives of the trial
    o Secondary efficacy measure:

    - The proportion of subjects who have a successful visual acuity outcome at 60 weeks and had no need for rescue therapy in the first year after treatment.

    - Time from treatment initiation to first use of rescue therapy.

    - Mean visual acuity change (in VA letters) from baseline at 60 weeks, and at each visit.
    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.
    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 > 500µm 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 pupillary 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 high 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 a recent history of acute coronary syndrome, coronary angioplasty, aorto-coronary bypass, or stroke.
    17. Patients with any other condition, which in the judgment of the investigator would prevent the patient from completing the study;
    18. Premenopausal women not using adequate contraception.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints: Ocular safety will be evaluated by assessing:
    · Incidence of adverse events/serious adverse events
    · Visual acuity
    · Ophthalmic examination
    · Intraocular pressure
    · Fundus findings

    Efficacy Endpoints

    Primary efficacy measure:
    . 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).

    Secondary efficacy measures:
    . The proportion of patients who have a successful visual acuity outcome at week 60 and had no need for rescue therapy with Lucentis®.
    . Time from treatment initiation to first use of rescue therapy.
    . The distribution of change in visual acuity from baseline to 60 weeks (i.e. proportion of patients with any numbers of lines of vision lost or gained).
    . The proportion of patients at week 60 with a 3, or more, line gain in vision.
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Last visit (week 104 visit) of last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months34
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months34
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 330
    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)
    No further treatment is anticipated at this stage.
    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 Decision2007-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-12
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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