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    The EU Clinical Trials Register currently displays   43845   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:2006-000737-36
    Sponsor's Protocol Code Number:206207-015
    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:2006-06-15
    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 number2006-000737-36
    A.3Full title of the trial
    A 6-Week, Multicenter, Masked, Randomized Trial (with a 20-Week Masked Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System Compared with Sham DEX PS DDS Applicator System in the Treatment of Non Infectious Ocular Inflammation of the Anterior Segment in Patients with Anterior Uveitis
    A.4.1Sponsor's protocol code number206207-015
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Non-infectious ocular inflammation of the anterior segment in anterior uveitis
    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 Sham DEX PS DDS Applicator System (needle-less applicator) in the treatment of non-infectious ocular inflammation of the anterior segment in patients with anterior uveitis
    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 the treatment of non-infectious ocular inflammation of the anterior segment in patients with anterior uveitis
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age
    2. Diagnosis of persistent non-infectious anterior uveitis in at least one eye, based on the standardization of uveitis nomenclature for reporting clinical data workshop (SUN Working Group. AJO 2005;140:509-516). For the diagnosis of anterior uveitis (e.g. iritis, iridocyclitis, anterior cyclitis), the anterior chamber must be the primary site of inflammation.
    2.1. Persistent anterior segment inflammation defined as lasting > 3 months prior to the time of the screening visit
    2.2. Patients with secondary posterior segment inflammation (e.g., anterior vitreous cell, mild vitreous haze, peripheral vasculitis, optic nerve edema, or cystoid macular edema) are eligible if, in the opinion of the investigator, the anterior segment inflammation is the principal source of posterior segment inflammation
    3. Anterior chamber cell score of at least +2 at both the screening (Days -14 to -4) and baseline (Day -4 to 0) visits in the study eye despite topical corticosteroids at least three times a day for at least two weeks prior to baseline
    4. Best-corrected ETDRS visual acuity score at screening and baseline of ≥ 35 letters (i.e. Snellen equivalent of approximately 20/200 or better) in the study eye
    5. Media clarity other than vitreous haze, pupillary dilation, and patient cooperation sufficient for adequate visualization of the optic nerve in the study eye
    6. Allowable treatments at screening, baseline and treatment (Day 0) visits:
    6.1 Topical corticosteroids or NSAIDs if on stable doses of at least three times a day for at least 2 weeks prior to screening and remain stable through treatment (Day 0)
    6.2 Systemic immunosuppression if doses are stable for at least 3 months prior to screening and remain stable through treatment (Day 0)
    6.3 Systemic corticosteroids if daily doses are ≤20 mg/day oral prednisone (or equivalent) are stable for at least 1 month prior to screening and remain stable through treatment (Day 0)
    6.4 Topical cycloplegia (e.g. homatropine, atropine) at the investigator’s discretion
    7. Female patients of childbearing potential must have a negative urine pregnancy test at the treatment (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
    12. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures
    E.4Principal exclusion criteria
    General exclusion criteria:
    1. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
    2. Uncontrolled systemic disease
    3. Participation in an investigational trial within 30 days of study entry
    4. Use of warfarin/heparin/enoxaparin or similar anticoagulant agent ≤ 2 weeks prior to the treatment visit
    5. Known allergy or sensitivity to the study medications, any component of the delivery vehicle, any corticosteroid, or any diagnostic agents used during the study (e.g., fluorescein, dilation drops)
    6. Anticipated need to initiate or change doses of current systemic immunosuppression or systemic corticosteroids during the first 6 weeks of the study
    7. Any condition (including inability to read visual acuity charts or language barrier) that precludes patient’s ability to comply with study requirements including completion of the study
    8. Patient has a condition or is in a situation that 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
    Ocular exclusion criteria:
    1. Previous enrollment in a DEX PS DDS clinical trial
    2. IOP > 21 mm Hg at screening or baseline
    3. History of clinically significant IOP elevation in response to corticosteroid treatment in either eye (defined as an increase of >10 mm Hg and an absolute IOP of ≥25 mm Hg without the use of anti-glaucoma medications) unless there is a functioning trabeculectomy or seton (with IOP <18 mm Hg at screening and baseline) and there is no significant visual field loss in the investigator’s opinion
    4. History, diagnosis, or clinical findings of ocular hypertension or glaucoma (e.g. elevated IOP, optic nerve head change consistent with glaucoma, glaucomatous visual field loss) in the study eye unless there is a functioning trabeculectomy or seton (with IOP <18 mm Hg at screening and baseline) and there is no significant visual field loss in the investigator’s opinion. Patients with a history of episodic increases in IOP due to inflammation and not due to corticosteroids may be eligible if they meet all other IOP and glaucoma medication exclusions
    5. Use of anti-glaucoma medications within 4 weeks prior to the screening visit or any use between screening and treatment visits
    6. History of central serous chorioretinopathy in either eye
    7. Any active ocular infection (i.e. bacterial, viral, parasitic, or fungal) in either eye at screening, baseline or treatment visits
    8. Presence of active or inactive toxoplasmosis in either eye
    9. Contraindication to pupil dilation in either eye
    10. Any other ocular disease in the study eye that can interfere with the diagnosis or the assessment of disease progression such as corneal edema, posterior synechiae, iris or angle neovascularization
    11. Periocular corticosteroid injections to the study eye ≤ 16 weeks prior to the treatment visit
    12. History of any intravitreal drug injection to the study eye ≤ 26 weeks prior to the treatment visit
    13. History of any intravitreal corticosteroid injection to the study eye unless all of the following criteria are met:
    a. The only corticosteroid injected intravitreally was triamcinolone acetonide
    b. The most recent dose was >26 weeks prior to the treatment visit
    c. All doses were ≤ 4 mg
    14. Any previous use of RetisertTM (fluocinolone acetonide intravitreal implant) in the study eye
    15. Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye ≤ 90 days prior to the treatment visit
    16. Aphakia or anterior chamber intraocular lens in the study eye (posterior chamber IOL is acceptable)
    17. History of pars plana vitrectomy in the study eye
    18. History of herpetic infection in the study eye or adnexa
    19. Presence of visible scleral thinning or ectasia in the study eye at screening, baseline, or treatment visit
    20. Best-corrected visual acuity score < 34 letters (approximately 20/200 on the Snellen scale) in the non-study eye using the ETDRS method at the screening or baseline visit
    21. Presence of anterior segment inflammation in the study eye that, in the opinion of the investigator, is primarily due to a surgical complication
    22. Uveitis expected to be unresponsive to corticosteroids (e.g. Fuchs’) or uveitis unresponsive to prior corticosteroids
    23. Hypotony (IOP < 5 mm Hg or clinical signs such as choroidals, choroidal or corneal folds) or pre-phthisis (e.g. scleral thickening on ultrasonography, decreasing globe size)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the anterior chamber cell score measured by biomicroscopy and based on the cell count, as follows:
    0 = 0 cells*
    +0.5 = 1 – 5 cells (trace)**
    +1 = 6 – 15 cells
    +2 = 16 – 25 cells
    +3 = 26 – 50 cells
    +4 = > 50 cells

    Note hypopyon if present.

    * Rare cells, defined as < 1 cell seen per field, should be graded as zero
    ** Record actual cell count on Case Report Form for +0.5 grade only

    There is no primary safety endpoint for the study.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 100
    F.4.2.2In the whole clinical trial 189
    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 Decision2006-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
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