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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2005-005921-73
    Sponsor's Protocol Code Number:CRFB002A2303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-27
    Trial results View 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 number2005-005921-73
    A.3Full title of the trial
    "Estudio de fase IIIB, multicéntrico, abierto, de 12 meses de duración para evaluar la seguridad, tolerabilidad y eficacia de ranibizumab (0.3 mg) en pacientes con neovascularización coroidea subfoveal secundaria a la degeneración macular asociada a la edad"
    A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
    A.3.2Name or abbreviated title of the trial where available
    SUSTAIN
    A.4.1Sponsor's protocol code numberCRFB002A2303
    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 SponsorNovartis Farmacéutica, S.A.
    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 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.2.5The 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 nameLucentis
    D.3.2Product code RFB002
    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.3.9.2Current sponsor codeRFB002
    D.3.9.3Other descriptive namerhuFab V2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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
    Hombres y mujeres ≥50 años de edad con neovascularización coroidea subfoveal secundaria a la degeneración maculara asociada a la edad.
    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
    The primary objective of this study is to estimate the incidence of ocular adverse events (AEs) in patients with CNV secondary to AMD who are treated with 0.3 mg intravitreal ranibizumab.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. To evaluate the mean change in best corrected visual acuity (BCVA) from Baseline to Months 3 and 12.
    2. To evaluate the mean change in retinal thickness as assessed with OCT from Baseline to Months 3 and 12.
    3. To evaluate the time to the first retreatment and the total number of treatments.

    Exploratory objectives:
    1. To evaluate the interaction between edema reduction and the change/status of visual acuity to support establishment of edema reduction as a surrogate endpoint.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Signed informed consent form
    2. Male or female patients >50 years of age
    3. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
    4. The total area of CNV (including both classic and occult components) encompassed within the lesion must be ³ 50% of the total lesion area
    5. The total lesion area must be ≤ 12 disc areas
    6. Patients who have a BCVA score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
    7. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
    E.4Principal exclusion criteria
    1. Previous treatment with intravitreally (in either eye) or intravenously administered Avastin ™ (bevacizumab)
    2. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy (Visudyne®) or pegaptanib sodium (Macugen®) in the study eye within 30 days preceding Day 1
    3. Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
    4. History of surgical intervention in the study eye within two months preceding Day 1
    5. Previous participation in any studies of investigational drugs within one month preceding Day 1(excluding vitamins and minerals and study CRFB002A2301)
    6. Concurrent use of systemic anti-VEGF agents
    7. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol
    8. Concomitant use of chronic NSAIDs for more than seven consecutive days or systemic or topical ocular corticosteroids for three or more consecutive days within six months prior to screening) or at any time during the study. Note that ASA (aspirin) taken as “low dose” up to 100 mg qd for prophylaxis of myocardial infarction and/or stroke is permitted during study
    9. Previous treatment with or participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate or corticosteroids, etc.).
    10. Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases
    11. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period
    12. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
    13. Presence of retinal pigment epithelial tear involving the macula in the study eye
    14. History of idiopathic or autoimmune-associated uveitis in either eye
    15. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
    16. History of glaucoma filtration surgery or corneal surgery
    17. Extracapsular extraction of cataract with phacoemulsification within 2 months preceding Day 1, or a history of post-operative complications within the last 12 months preceding Day 1 in the study eye (uveitis, cyclitis etc.)
    18. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation).
    19. Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
    20. Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia; for subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye can not exceed -8 diopters of myopia
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to estimate the incidence of ocular adverse events (AEs) in patients with CNV secondary to AMD who are treated with 0.3 mg intravitreal ranibizumab.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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.8.5The 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 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 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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 458
    F.4.2.2In the whole clinical trial 500
    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 Decision2006-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
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