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    Summary
    EudraCT Number:2008-001469-28
    Sponsor's Protocol Code Number:SA2008
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-001469-28
    A.3Full title of the trial
    A randomized, double-masked study with intraocular Bevacizumab (Avastin®) compared with intravitreal Ranibizumab (Lucentis®) in patients with persistent diabetic macular edema or persistent active neovascularisation following lasercoagulation
    A.4.1Sponsor's protocol code numberSA2008
    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 SponsorDep. of Ophthalmology, Medical University of Vienna
    B.1.3.4CountryAustria
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Austria GmBH
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameAvastin
    D.3.2Product code EU/1/04/300/001-002
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravitreal use
    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 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 typeecombinant monoclonal antibody
    D.IMP: 2
    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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 EU/1/06/374/001
    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.3.11 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 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 typerecombinant monoclonal antibody fragment
    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
    persistent diabetic macula edema or persistent diabetic proliferative retinopathy after lasercoagulation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012689
    E.1.2Term Diabetic retinopathy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • For Group A (persitient macular edema): To investigate the change in macular edema measured with standard optical coherence tomography (OCT) and the absolute change in visual acuity following intravitreal administered injections of Bevacizumab (Avastin®) compared with intravitreal administered injections of Ranibizumab (Lucentis®) in patients with persistent diabetic macular edema following grid lasercoagulation. • For Group B (persistent neovascularisation): To investigate the change of neovascularisation and vitreous hemorrhage following intravitreal administered injections of Bevacizumab (Avastin®) compared with intravitreal administered injections of Ranibizumab (Lucentis®) as assessed by fundus photography and fluorescence angiography and the absolute change in visual acuity.
    E.2.2Secondary objectives of the trial
    • To explore the structural mechanisms of Bevacizumab (Avastin®) and Ranibizumab (Lucentis®) on persistent diabetic macular edema or persistent neovascularisation as assessed by fundus photography, fluorescein angiography, and ultra high-resolution optical coherence tomography. • To investigate the safety and tolerability of Bevacizumab (Avastin®), a recombinant humanized anti VEGF monoclonal antibody, administered as multiple intravitreal injections in patients with persistent diabetic macular edema or persistent neovascularisation following lasercoagulation. • To assess the effect of Bevacizumab (Avastin™) and Ranibizumab (Lucentis) on intraocular concentrations of inflammatory cytokines and growth factors
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent • Age ≥18 years • Patients with type 1 or type 2 diabetes mellitus • HbA1C between 6% and 9 %. • Patients with persistent diabetic macular edema with center involvement following completed grid lasercoagulation in the study eye • Last perifoveolar laser treatment 3 months before study entry • Central macular thickness (macular edema) of at least 300 - 550 microns in the central subfield as measured by OCT • Not eligible for any currently approved treatments or experimental protocols • Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/200 (Snellen equivalent) in the study eye • Patients with decrease in vision in the study eye due to foveal thickening from diabetic macular edema and not to other causes, in the opinion of the investigator • Patients without a necessity for panretinal laser photocoagulation for at least 3 months after study inclusion • If both eyes are eligible, the one with the worse visual acuity will be selected for study treatment unless, based on medical reason, the investigator deems the other eye have got more benefit from study treatment.
    E.4Principal exclusion criteria
    • A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure • History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week Prior/Concomitant Treatment • Panretinal laser photocoagulation within the past 3 months or macular laser photocoagulation within the past 3 months in the study eye • Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3 months in the study eye • Previous participation in clinical trial involving anti-angiogenic drugs (pegabtanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) • History of submacular surgery or other surgical intervention for diabetic macular edema except grid lasercoagulation in the study eye • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) Diabetic Retinopathy Characteristics • High risk proliferative diabetic retinopathy in the study eye without complete panretinal lasercoagulation and having a risk for intravitreal bleeding Concurrent Ocular Conditions • Active intraocular inflammation (grade trace or above) in either eye • Vitreomacular traction in the study eye evident by OCT • Current vitreous hemorrhage in the study eye (Group A) • Infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmuneassociated uveitis in either eye • Structural damage to the center of macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques (Group A) • Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularisation • Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0 • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) • History of glaucoma filtration surgery, corneal transplantation in the study eye Concurrent Systemic Conditions • Systemic hypertension (> 150/100 mmHg) • History of myocardial infarction (in anamnesis or signs in ECG) • History of congestive heart failure • History of stroke or transient ischemic attacks • Significant abnormalities on laboratory testing (signs on failure of kidney, liver disease) • Premenopausal women not using adequate contraception and pregnant or nursing women The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; an IUD; or contraceptive hormone implant or patch. • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications • Current treatment for active systemic infection Other • History of allergy to fluorescein, not amenable to treatment • Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded • Inability to comply with study or follow up procedures
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy of the treatment with intravitreal administered injections of Bevacizumab (Avastin®) compared with intravitreal administered injections of Ranbizumab (Lucentis) in patients with persistent diabetic macular edema following grid lasercoagulation and with persistent active neovasculariasation following panretinal scatter coagulation is examined using the following parameters:Visual acuity measured by ETDRS chartsCentral retinal thickness as measured by standard Optical Coherence Tomography (OCT) in Group A.Reduction of neaovascularisation and Retinopathy Severity Score as measured by FLA and documented with fundus photography in Group B.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2009-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
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