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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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:2004-004996-12
    Sponsor's Protocol Code Number:206207-010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-004996-12
    A.3Full title of the trial
    A 3-Year, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Diabetic Macular Edema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    N/A
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number206207-010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00168389
    A.5.4Other Identifiers
    Name:MEADNumber:N/A
    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 Limited
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan - Regulatory Affairs Department
    B.5.2Functional name of contact pointSenior Regulatory Manager
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL71YL
    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 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 nameDEX PS DDS Applicator System
    D.3.2Product code 9632X
    D.3.4Pharmaceutical form Implant
    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.3.9.2Current sponsor codeAGN206207
    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 Yes
    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 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 nameDEX PS DDS Applicator System
    D.3.2Product code 9635X
    D.3.4Pharmaceutical form Implant
    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.3.9.2Current sponsor codeAGN206207
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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 Yes
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboRoute of administration not applicable
    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
    To treat damage (swelling) of the retina (the light sensitive part of the eye) caused by complications of diabetes.
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic macular oedema
    E.1.2System Organ Class 10015919 - Eye disorders
    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 the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) and 350 µg DEX PS DDS Applicator System (350 µg dexamethasone) compared with a Sham DEX PS DDS Applicator System (needle-less applicator) in patients with diabetic macular edema.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) compared with the 350 µg DEX PS DDS Applicator System
    (350 µg dexamethasone) in patients with diabetic macular edema.
    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). Any one of the following will be considered to be sufficient evidence that diabetes is present:
    - Current regular use of insulin for the treatment of diabetes
    - Current regular use of oral hypoglycemic agents for the treatment of diabetes
    - Diabetes defined as (ADA guidelines):
    • Symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) plus plasma glucose concentration at any time of the day regardless of time since last meal ≥ 200 mg/dl (11.1 mmol/l) or
    • Eight-hour fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/l) or
    • Two-hour postload (75 g) glucose ≥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test
    3. Diabetic macular edema in the study eye defined as clinically
    observable macular edema involving the center of the macula (fovea)
    associated with diabetic retinopathy, with any of the following
    characteristics:
    a) Prior medical therapy for diabetic macular edema
    b) Prior macular laser(s) for diabetic macular edema with the most
    recent laser at least 3 months prior to Baseline/ Qualification
    where, in the opinion of the investigator, the patient will be able to
    improve 15 or more letters in BCVA from baseline with the
    resolution of the macular edema despite the presence of macular
    laser scars
    c) In the investigator’s opinion the patient would not benefit from
    macular laser treatment
    d) The patient refuses laser treatment
    4. BCVA score between 34 letters (approximately 20/200 Snellen equivalent) and
    68 letters (approximately 20/50 Snellen equivalent) in the study eye measured by the ETDRS method at qualification/baseline
    5. Retinal thickness of ≥ 300 μm by OCT in the 1mm central macular
    subfield of the study eye at qualification/baseline as determined by the
    investigator
    6. Patients who have received intravitreal triamcinolone acetonide must
    satisfy the following:
    • The intended dose for each injection was 4 mg or less
    • The most recent dose was at least 6 months prior to
    qualification/baseline visit
    • No treatment-related adverse event was seen that, in the
    opinion of the investigator, has the potential to worsen or
    reoccur with study treatment
    7. Female patients of childbearing potential must have a negative urine pregnancy test at the randomization (day 0) visit
    8. Written informed consent has been obtained
    9. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
    10. Written Data Protection Consent (European sites only) has been obtained
    11. Written documentation has been obtained, in accordance with state and country privacy requirements, where applicable
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease or current immunosuppressive diseases
    (e.g. HIV+ or AIDS)
    2. Initiation of medical therapy for diabetes or a change from oral
    hypoglycemic agents to insulin therapy within 4 months prior to the
    qualification/baseline visit
    3. Blood HbA1c level greater than 10% at the qualification/baseline visit
    4. Renal failure requiring hemodialysis or peritoneal dialysis within 6
    months prior to the qualification/baseline visit
    5. Adjusted glomerular filtration rate (GFR) less than 50 mL/min based on
    the Modified Diet in Renal Disease (MDRD) formula adjusted for body
    surface area, at the qualification/baseline visit
    6. Any ocular condition in the study eye that in the opinion of the
    investigator would prevent a 15-letter improvement in visual acuity
    (e.g., severe macular ischemia, extensive macular laser scarring or
    atrophy)
    7. Presence of branch retinal vein occlusion, central retinal vein occlusion,
    uveitis, pseudophakic cystoid macular edema or any other condition in
    the study eye which could be contributing to macular edema
    8. Presence of an epiretinal membrane or vitreo-retinal interface changes in
    the study eye which, in the opinion of the investigator, is the primary
    cause of macular edema, or is severe enough to prevent improvement in
    visual acuity despite reduction in macular edema
    9. History of IOP elevation in response to steroid treatment in either eye
    that resulted in any of the following:
    1) a ≥ 10 mm Hg increase in IOP from baseline with an absolute IOP
    ≥25 mm Hg
    2) required therapy with 3 or more anti-glaucoma medications
    10. History of glaucoma or optic nerve head change consistent with
    glaucoma damage, and/or glaucomatous visual field loss in the study
    eye. Patients with a history of previous angle-closure or similar
    conditions that have been successfully treated with either a laser or
    surgical peripheral iridotomy are allowed as long as the visual fields
    and optic nerves have been stable for > 1 year prior to study entry and
    the patient has been and can be safely dilated
    11. Ocular hypertension in the study eye at qualification/baseline with any
    of the following:
    1) IOP > 23 mm Hg if taking no anti-glaucoma medications
    2) IOP > 21 mm Hg if taking one anti-glaucoma medication
    3) Use of 2 or more anti-glaucoma medications (combination products
    should be considered 2 medications)
    Note: Anti-glaucoma medications or lack thereof must be stable for at
    least 4 weeks prior to qualification/baseline.
    12. Aphakia or presence of anterior chamber intraocular lens in the study
    eye
    13. Active optic disc or retinal neovascularization in the study eye at
    qualification/baseline
    14. Active or history of choroidal neovascularization in the study eye
    15. Presence of rubeosis iridis in the study eye at qualification/baseline
    16. Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in
    either eye at qualification/baseline
    17. History of herpetic infection in the study eye or adnexa
    18. Presence of active or inactive toxoplasmosis in either eye at
    qualification/baseline
    19. Presence of visible scleral thinning or ectasia in the study eye
    20. Media opacity in the study eye at qualification/baseline that precludes
    clinical and photographic evaluation (including but not limited to
    preretinal or vitreous hemorrhage, lens opacity)
    21. Intraocular surgery, including cataract surgery, and/or laser of any type
    in the study eye within 90 days prior to qualification/baseline
    22. History of central serous chorioretinopathy in either eye
    23. History of pars plana vitrectomy in the study eye
    24. Anticipated need for ocular surgery or laser in the study eye within 1
    year following the qualification/baseline visit (e.g., panretinal
    photocoagulation (PRP), cataract surgery)
    25. History of use of intravitreal steroids in the study eye other than
    triamcinolone acetonide
    26. History of use of intravitreal bevacizumab, ranibizumab, or pegaptanib
    in the study eye within 3 months prior to qualification/baseline visit
    27. History of use of any intravitreal agent in the study eye other than
    triamcinolone acetonide, bevacizumab, ranibizumab, or pegaptanib, or
    intravitreal doses of triamcinolone acetonide > 4mg, bevacizumab >
    1.25 mg, ranibizumab > 0.5 mg, or pegaptanib > 0.3 mg
    28. Periocular depot of steroids to the study eye within 6 months prior to
    qualification/baseline
    29. Use of systemic steroids (e.g., oral, intravenous, intra-articular,
    epidural, intra-bursal) within 1 month prior to the qualification/baseline
    visit or anticipated use at any time during the study. Inhaled and
    intranasal steroids are allowed
    30. For patients who participate in therapeutic drug monitoring evaluation
    only: use of dexamethasone within 1 month prior to
    qualification/baseline or anticipated use during the first 90 days in any
    form/route of administration
    DUE TO SPACE RESTRICTIONS, ONLY EXCLUSION CRITERIA 1-30 ARE LISTED.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for countries/regions other than the United States will be BCVA average change from baseline during the study (AUC approach) using observed data in the study eye.

    Best Corrected Visual Acuity (BCVA) is the primary efficacy variable and will be measured using the ETDRS method. It will be measured in both eyes (study eye and non-study eye) at the qualification visit and each follow-up visit. BCVA will be performed following manifest refraction, except 1, 7 and 21 days after the study treatment or re-treatment,. At days 1, 7 and 21 after a treatment or re-treatment, visual acuity (VA) evaluations may be performed using refraction obtained at baseline or at the preceding re-treatment visit, respectively. These VA evaluations will be considered as safety measures but not as efficacy measures. All other VA evaluations will be considered as both safety and efficacy measures.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36/39 months
    E.5.2Secondary end point(s)
    - Mean BCVA change from baseline at each scheduled follow-up visit.
    - Proportion of patients with a BCVA improvement of 10 or more letters from baseline
    - Proportion of patients with a BCVA improvement of 15 or more letters from baseline
    - Average proportion of patients with a BCVA improvement of 15 or more letters from baseline 3 month after each injection.
    - Analysis of BCVA change from baseline at each scheduled follow-up visit in the distribution of 7 categories: (1) ≥ 15 letters better, (2) ≥ 10 and < 15 letters better, (3) ≥ 5 and < 10 letters better, (4) no change (ie, change of -4 to +4 letters), (5) ≥ 5 and
    < 10 letters worse, (6) ≥ 10 and < 15 letters worse and (7) ≥ 15 letters worse.
    - Other secondary efficacy analyses include contrast sensitivity, FA, FP and retinal thickness by optical coherence tomography (OCT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36/39 months
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    sham controlled
    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
    Sham applicator
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Australia
    Brazil
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Democratic People's Republic of
    New Zealand
    Philippines
    Poland
    Portugal
    Singapore
    South Africa
    Spain
    Taiwan
    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
    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 months96
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months96
    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: 1055
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 510
    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)
    Once patients have exited from the study, the investigator will be responsible for either continuing their care personally (at the same hospital), or referring them back to their regular ophthalmologist. In either case, patients will be treated according to current best clinical practice with existing treatments.
    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 Decision2007-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-01
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