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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2004-002502-29
    Sponsor's Protocol Code Number:206207-009
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-002502-29
    A.3Full title of the trial
    A Six-Month Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial (with Six-Month Open-Label Extension) 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 Macular Edema following Central Retinal Vein Occlusion or Branch Retinal Vein Occlusion.
    A.4.1Sponsor's protocol code number206207-009
    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
    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
    Macular edema due to Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO)
    MedDRA Classification
    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 macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
    E.2.2Secondary objectives of the trial
    To evaluate 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 macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
    To assess the safety of the 700 µg DEX PS DDS Applicator System for an additional 6 months in patients who qualify for treatment in an open-label extension.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age
    2. Macular edema in the study eye with all of the following characteristics:
    -involving the center of the macula (fovea)
    -due to BRVO or CRVO
    -with a duration of 6 weeks to 9 months prior to qualification/baseline visit for
    CRVO patients and a duration of 6 weeks to 12 months prior to
    qualification/baseline visit for BRVO patients
    -VA decrease attributable to the edema
    -in the investigator’s opinion, unlikely to be adversely affected if not treated for 6
    months
    3. 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
    4. Retinal thickness of ≥ 300 µm by OCT in the central 1 mm macular subfield of
    the study eye at qualification/baseline as determined by the investigator
    5. Female patients of childbearing potential must have a negative urine pregnancy
    test at the randomization (day 0) visit
    6. Written informed consent has been obtained
    7. Written Authorization for Use and Release of Health and Research Study
    Information (US sites only) has been obtained
    8. Written Data Protection Consent (European sites only) has been obtained
    9. Written documentation has been obtained, in accordance with state and country
    privacy requirements, where applicable
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease
    2. Any ocular condition in the study eye that, in the opinion of the investigator,
    would prevent a 15-letter improvement in visual acuity (eg, severe macular
    ischemia)
    3. Presence of an epiretinal membrane 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
    4. 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;
    2) IOP ≥ 25 mm Hg; or
    3) required therapy with anti-glaucoma medications
    5. 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 that has been successfully treated with either a
    laser or surgical peripheral iridotomy (PI) are allowed as long as the visual fields
    have been stable for > 1 year prior to study entry and the patient has been and can
    be safely dilated.
    6. 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; or
    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.
    7. Aphakia or presence of anterior chamber intraocular lens in the study eye
    8. Diabetic retinopathy in either eye
    9. Active or history of choroidal neovascularization in the study eye
    10. Presence of rubeosis iridis in the study eye at qualification/baseline
    11. Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in either eye
    at qualification/baseline
    12. History of herpetic infection in the study eye or adnexa
    13. Presence of active or inactive toxoplasmosis in either eye at qualification/baseline
    14. Presence of visible scleral thinning or ectasia in the study eye at
    qualification/baseline
    15. Intraocular surgery, including cataract surgery, and/or laser of any type in the
    study eye within 90 days prior to qualification/baseline
    16. History of central serous chorioretinopathy in either eye
    17. History of pars plana vitrectomy in the study eye
    18. History of use of intravitreal steroids or any intravitreal injectable drug in the
    study eye
    19. Periocular depot of steroids to the study eye within 6 months prior to
    qualification/baseline
    20. Use of systemic steroids (e.g., oral, intravenous, intra-articular, epidural, intrabursal) within 1 month prior to qualification/baseline visit or anticipated use at
    any time during the study. Inhaled and intranasal steroids are allowed.
    21. Use of topical or systemic carbonic anhydrase inhibitors (e.g., Azopt®, Trusopt®,
    Diamox®) within 1 month prior to qualification/baseline visit or anticipated use at
    any time during the study
    22. Use of immunosuppressants, immunomodulators, antimetabolites, and/or
    alkylating agents use within 6 months prior to qualification/baseline or anticipated
    use at any time during the study
    23. Use of topical ophthalmic steroids or topical non-steroidal anti-inflammatory
    drugs (NSAIDs) within 1 month prior to qualification/baseline or anticipated use
    within the 12-month study period in the study eye
    24. Use of warfarin, heparin, enoxaparin, or similar anticoagulants within 2 weeks
    prior to randomization or anticipated use at any time during the study
    25. BCVA score < 34 letters (approximately 20/200 Snellen equivalent) in the nonstudy eye using the ETDRS method at qualification/baseline
    26. Known allergy or hypersensitivity to the study medication or its components
    27. Known allergy or contraindication to the use of fluorescein or povidone iodine
    28. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
    29. Current enrollment in an investigational drug or device study or participation in
    such a study within the 30 days prior to qualification/baseline
    E.5 End points
    E.5.1Primary end point(s)
    Best Corrected Visual Acuity (BCVA) is the primary efficacy parameter and BCVA will be measured using the ETDRS method at each study visit (at Days 1 and 7 following the initial treatment or of open-label extension. BCVA will be considered as safety parameter).
    The primary efficacy variable is the proportion of patients with a BCVA improvement of 15 or more letters from baseline in the study eye at initial treatment Day 180.
    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 and open label on last 6 months
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 months27
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months45
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 550
    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 Decision2004-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-17
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