Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-004996-12
    Sponsor's Protocol Code Number:206207-010
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-01
    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 ConcernedBelgium - FPS Health-DGM
    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.4.1Sponsor's protocol code number206207-010
    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 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 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 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 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 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) 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 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 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 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) 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic macular Edema
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    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)
    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.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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13Others Information not present in EudraCT
    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.8.3 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 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 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 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 months60
    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 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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 343
    F.4.2.2In the whole clinical trial 860
    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 Decision2008-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA