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    Summary
    EudraCT Number:2010-022364-12
    Sponsor's Protocol Code Number:BAY86-5321/91745
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-16
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-022364-12
    A.3Full title of the trial
    A randomized, double masked, active controlled, phase III study of the efficacy and
    safety of repeated doses of intravitreal VEGF Trap-Eye in subjects with diabetic
    macular edema
    Egy randomizált, kettősen elmaszkolt, aktív kontrollos, III. fázisú vizsgálat az ismételt dózisokban az üvegtestbe adott VEGF Trap-Eye hatékonyságának és biztonságosságának felmérésére diabeteses macula-ödémában szenvedő betegek esetében.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of VEGF Trap-Eye in diabetic macular edema (DME) with central involvement
    A VEGF Trap-Eye hatékonysága és biztonságossága centrális érintettséggel járó DME esetében.
    A.3.2Name or abbreviated title of the trial where available
    VIVID DME
    A.4.1Sponsor's protocol code numberBAY86-5321/91745
    A.5.4Other Identifiers
    Name:VIVID DMENumber:PXL 112342
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointCTP Team / Ref: "EU CTR" / S102 - R
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstr. 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 30 300139003
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.com
    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 nameVEGF Trap-Eye
    D.3.2Product code 80418745
    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 INNAflibercept
    D.3.9.2Current sponsor codeBAY86-5321
    D.3.9.3Other descriptive nameVEGF Trap-Eye
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) 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 typerecombinantly produced fusion protein
    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
    Diabetic macular edema with central involvement
    Centrális érintettséggel járó diabeteses macula-ödéma
    E.1.1.1Medical condition in easily understood language
    Patients with fluid retention in the back of the eye as a result of diabetes
    mellitus
    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 LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 100000004853
    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 of intravitreally (IVT) administered VEGF Trap Eye in comparison to laser treatment in improving best corrected visual acuity (BCVA) in subjects with diabetic macular edema (DME) with central involvement
    Az üvegtestbe (IVT) beadott VEGF Trap-Eye hatékonyságának és biztonságosságának összehasonlítása a lézerkezeléssel, a legjobb korrigált látásélesség (Best Corrected Visual Acuity, BCVA) javulásának alapján centrális érintettséggel járó diabeteses macula-ödémában szenvedő betegek esetében.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of IVT administered VEGF Trap Eye in subjects with DME
    Az IVT beadott VEGF Trap-Eye biztonságosságának vizsgálata DME-ben szenvedő betegek esetében.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic sub-study for the the collection of blood samples for DNA analyses.
    E.3Principal inclusion criteria
    1. Adults ≥ 18 years with type 1 or 2 diabetes mellitus.
    2. Subjects with DME secondary to diabetes mellitus involving the center of
    the macula (defined as the area of the center subfield of optical coherence tomography [OCT]) in the study eye.
    3. Decrease in vision determined to be primarily the result of DME in the study eye
    4. Retinal thickness as assessed by OCT of ≥300 µm in the study eye.
    5. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye.
    6. Willing and able to comply with clinic visits and study-related procedures.
    7. Provide a signed informed consent form (ICF). In Japan only, the informed consent form for a subject under the age of 20 years will require the co-signature of the subject’s legally authorized representative.
    E.4Principal exclusion criteria
    1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
    2. History of vitreoretinal surgery and/or including scleral buckling in the study eye
    3. Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
    4. More than 2 previous macular laser treatments in the study eye or, in the opinion of the investigator, the subject has no potential to benefit from laser treatments (eg, if too many laser treatments were applied in the past).
    5. Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
    6. Previous treatment with anti-antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
    7. Active, proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
    8. History of idiopathic or autoimmune uveitis in the study eye
    9. Cataract surgery within 90 days before Day 1 in the study eye
    10. Aphakia in the study eye
    11. Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 30 days before Day 1
    12. Any other intraocular surgery within 90 days of Day 1 in the study eye
    13. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
    14. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
    15. Pre-retinal fibrosis involving the macula in the study eye
    16. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates.
    17. Ocular inflammation including trace or above in the study eye
    18. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
    19. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
    20. Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
    21. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥ 8 diopters
    22. Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
    23. Only 1 functional eye even if that eye is otherwise eligible for the study
    24. Ocular media of insufficient quality to obtain fundus and OCT images
    25. Current treatment for a serious systemic infection
    26. Administration of systemic anti-angiogenic agents within 180 days before Day 1
    27. Uncontrolled diabetes mellitus, as defined by HbA1c >12%.
    28. Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg while subject is sitting)
    29. History of either cerebral vascular accident and/or myocardial infarction within 180 days prior to Day 1
    30. Renal failure requiring dialysis or renal transplant
    31. 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, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications.
    32. Pregnant or breast-feeding women. In addition, to prevent exposure during pregnancy female subjects, male subjects, and their partners must agree to the following.
    33. Women of childbearing potential with either a positive pregnancy test result or no pregnancy test at baseline are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
    34. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study are excluded. (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or jelly)
    35. Allergy to fluorescein
    36. Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline of BCVA in ETDRS letters score at Week 52 compared to baseline (Day 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    10. May 2013
    E.5.2Secondary end point(s)
    Comparisons between each of the VEGF Trap-Eye arms and the laser arm
    on the secondary efficacy endpoints will be performed only when the
    respective VEGF Trap-Eye arm demonstrates statistically significant
    difference from laser arm on the primary endpoint at week 52. To control
    the type I error, the secondary endpoints will be tested sequentially in
    the order described below:
    -CRT assessed by OCT change from baseline to week 52
    -Proportion of subjects who gain at least 10 ETDRS letters from baseline
    to week 52
    -NEI VFQ-25 near activities subscale change from baseline to week 52
    -NEI VFQ-25 distance activities subscale change from baseline to week
    52
    E.5.2.1Timepoint(s) of evaluation of this end point
    10. May 2013
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    macular laser photocoagulation
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Australia
    Japan
    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
    End of trial is last visit of last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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) 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state86
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 263
    F.4.2.2In the whole clinical trial 375
    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)
    Not different from the expected normal treatment of that condition.
    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 Decision2011-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-30
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