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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2011-005631-20
    Sponsor's Protocol Code Number:206207-024
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-16
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2011-005631-20
    A.3Full title of the trial
    A Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of 700 μg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) to Ranibizumab in Patients With Diabetic Macular Edema.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of OZURDEX® versus Lucentis® in the treatment of Diabetic Macular Edema.
    A.3.2Name or abbreviated title of the trial where available
    Dexamethasone Posterior Segment Drug Delivery System versus Ranibizumab in Patients with DME
    A.4.1Sponsor's protocol code number206207-024
    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 SponsorAllergan Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628494444
    B.5.5Fax number+441628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 Yes
    D.2.1.1.1Trade name Ozurdex®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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.3.1Product name700 μg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)(Ozurdex®)
    D.3.4Pharmaceutical form Intravitreal implant in applicator
    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 INNDexamethasone
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 No
    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.3.1Product nameRanibizumab
    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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeSUB22314
    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) 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 Yes
    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
    Diabetic Macular Edema
    E.1.1.1Medical condition in easily understood language
    Diabetic Macular Edema
    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 evaluate whether treatment with 700 μg DEX PS DDS every 5 months provides a similar treatment effect on average change of best-corrected visual acuity (BCVA) as ranibizumab administered as per its European Summary of Product Characteristics (SmPC) in patients with DME
    E.2.2Secondary objectives of the trial
    • To evaluate the effects of 700 μg DEX PS DDS on central retinal thickness (CRT) and other anatomical changes relative to ranibizumab 0.5 mg in patients with DME.
    • To evaluate the effects of 700 μg DEX PS DDS on patient-reported outcomes (PROs) relative to ranibizumab 0.5 mg in patients with DME.
    • To evaluate the safety of 700 μg DEX PS DDS relative to ranibizumab 0.5 mg in patients with DME.
    • To evaluate the effect of 700 μg DEX PS DDS on BCVA average change in
    pseudophakic subgroup of patients relative to ranibizumab 0.5 mg in patients with DME
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age.

    2. Diagnosis of diabetes mellitus (type 1 or type 2) as defined by the World Health Organization/International Diabetes Federation (Report of a WHO/IDF consultation, 2006)
    - Fasting plasma glucose level ≥ 7.0 mmol/L (126 mg/dL) or
    - Plasma glucose ≥ 11.1 mmol/L (200 mg/dL) 2 hours after a 75 g oral glucose load as in a glucose tolerance test.

    3. Presence of macular edema associated with diabetic retinopathy defined as macular thickening by optical coherence tomography (OCT) assessed by the investigator in the study eye with the following characteristics:
    - involving the center of the macula (fovea)
    - VA decrease attributable to macular edema

    4. BCVA score ≥ 34 and ≤ 70 letters (approximately 20/200 to 20/40 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method in the study eye at the screening visit.

    5. Study eye mean retinal thickness by spectral domain OCT in the 1 mm central macular subfield of ≥ 300 μm with Spectralis (Heidelberg) or 275 μm with Cirrus (Zeiss) as determined by the investigator at the screening visit.

    6. (Both Eyes) Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures.

    7. Written informed consent has been obtained in accordance with state and country privacy requirements, where applicable.
    E.4Principal exclusion criteria
    Systemic conditions or treatments
    1. History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, might affect the interpretation of study results or render the patient at high risk from treatment complications.

    2. HbA1c (glycated hemoglobin) >12% at baseline.

    3. Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to baseline or anticipated change of anti-diabetic medications during the 1-year study participation.

    4. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to baseline or anticipated need for hemodialysis or peritoneal dialysis at any time during the study or adjusted glomerular filtration rate < 50 mL/min.

    5. Use of systemic (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) corticosteroids within 1 month prior to screening.

    6. Uncontrolled systemic disease

    Ocular concomitant conditions/disease
    7. Any current or history of ocular disease in the study eye, other than DME that in the opinion of the investigator may confound assessment of the macula or affect central vision (for example: exudative age-related macular degeneration [AMD], geographic atrophy, macular edema due to retinal vein occlusion, uveitis, angioid streaks, histoplasmosis, active or inactive cytomegalovirus, pathological myopia, retinal detachment, macular traction, macular fibrosis or scarring, macular hole, significant cataract).

    8. Increased intraocular pressure (IOP ≥ 22 mmHg) at screening or day 1, or diagnosis of glaucoma.

    9. Any active ocular inflammation or ocular infection (ie, bacterial, viral, parasitic, or fungal) in either eye at the screening visit.

    10. Aphakia in the study eye or break in the posterior capsule in the study eye, unless it is a small break resulted from a YAG laser posterior capsulotomy in association with prior posterior intraocular lens implantation

    11. Anticipated need for ocular surgery in the study eye during the 1-year study participation.

    12. Active proliferative diabetic retinopathy and/or rubeosis.

    13. BCVA score < 34 letters in fellow eye.

    Ocular treatment
    14. Laser photocoagulation to the study eye within 3 months prior to screening.

    15. Use of anti-VEGF treatment in study eye within 3 months prior to screening or use of systemic anti-VEGF within 6 months prior to screening
    16. Use of intravitreal triamcinolone within 6 months prior to screening.

    17. Use of topical intraocular, intravitreal (except triamcinolone, see above) or periocular corticosteroids within 3 months prior to screening in the study eye or ocular conditions in the study eye that require chronic concomitant therapy with topical, local ocular or systemically administered corticosteroids.

    18. History of use of DEX PS DDS within 9 months prior to screening.

    19. History of cataract surgery within the 3 months prior to baseline.

    20. History of vitrectomy.

    21. History of incisional glaucoma surgery.

    22. Known allergy, hypersensitivity or contraindication to the study medications, its components, fluorescein or povidone iodine.

    Compliance / administrative.
    23. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception.

    24. Current enrollment in an investigational drug or device study or participation in such a study within the 30 days prior to day 1

    25. Patient has a condition or is in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The average change from baseline in BCVA across all follow-up visits will be calculated for each patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every visit - screening, randomization (Day 1), Month 1-12 visits.
    E.5.2Secondary end point(s)
    (1) Change from baseline in the foveal thickness based on optical coherence tomography (OCT).

    (2) Change from baseline in total leakage area based on fluorescein angiography (FA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    OCT assessment at every visit (screening, randomization (Day1), Month 1-12 visits)
    FA assessment at screening, month 6 and month 12.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Brazil
    Denmark
    France
    Germany
    Israel
    Italy
    Netherlands
    Portugal
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    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
    LVLS
    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 months6
    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 months8
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The population targeted by this study has vision impairment which can affect writing. The legal authorized representative can only sign in case the subject can’t, though the subject has to confirm participation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 363
    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)
    Subjects will return to the expected normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Vision Institute Clinical Research Network
    G.4.3.4Network Country Portugal
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-13
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