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    Summary
    EudraCT Number:2006-000736-26
    Sponsor's Protocol Code Number:206207-014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-000736-26
    A.3Full title of the trial
    An 8-Week, Multicenter, Masked, Randomized Trial with an 18-Week Masked Extension to Assess the Safety and Efficacy of 700 g and 350 g 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 Posterior Segment in Patients with Intermediate Uveitis
    A.3.2Name or abbreviated title of the trial where available
    Uveithis study
    A.4.1Sponsor's protocol code number206207-014
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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
    D.3.4Pharmaceutical form Ophthalmic insert
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    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.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
    D.3.4Pharmaceutical form Ophthalmic insert
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    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.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
    Intermidiate Uveitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10022557
    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 g dose and the 350 g dose DEX PS DDS Applicator Systems 700 g dexamethasone and 350 g dexamethasone DEX PS DDS, respectively compared with Sham DEX PS DDS Applicator System needle-less applicator in the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate uveitis.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of the 700 g DEX PS DDS Applicator System 700 g dexamethasone compared with the 350 g DEX PS DDS Applicator System 350 g dexamethasone in the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate uveitis.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Male or female, at least 18 years of age Diagnosis of intermediate uveitis in at least one eye based on the standardization of uveitis nomenclature for reporting clinical data workshop. SUN Working Group classification report published AJO 2005; 140 509-516 . Suspected masquerade syndromes should be ruled out by the investigator prior to patient entry into the study Vitreous haze of at least 2 at both the screening and baseline visits in the study eye Best-corrected ETDRS visual acuity score of 35 to 68 letters inclusive Snellen equivalent approximately 20/40 20/200 at screening and baseline visits in the study eye Media clarity other than vitreous haze, pupillary dilation, and patient cooperation sufficient for adequate visualization of the optic nerve in the study eye
    E.4Principal exclusion criteria
    Ocular exclusion criteria Previous enrollment in a DEX PS DDS clinical trial IOP 21 mm Hg at screening or baseline 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 8805;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 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 Use of anti-glaucoma medications within 4 weeks prior to the screening visit or any use between screening and treatment visits History of central serous chorioretinopathy in either eye Any active ocular infection i.e. bacterial, viral, parasitic, or fungal in either eye at screening, baseline, or treatment visits Presence of active or inactive toxoplasmosis in either eye Contraindication to pupil dilation in either eye Any other ocular disease e.g. choroidal neovascularization, media opacity in the study eye that can interfere with the diagnosis or the assessment of disease progression Periocular corticosteroid injections to the study eye 8804; 16 weeks prior to the treatment visit History of any intravitreal drug injection to the study eye 8804; 26 weeks prior to the treatment visit 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 8804;4 mg Any previous use of RetisertTM fluocinolone acetonide intravitreal implant in the study eye Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye 8804; 90 days prior to the treatment visit Aphakia or anterior chamber intraocular lens in the study eye posterior chamber IOL is acceptable History of pars plana vitrectomy in the study eye History of herpetic infection in the study eye or adnexa Presence of visible scleral thinning or ectasia in the study eye at screening, baseline, or treatment visits Best-corrected ETDRS 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 Uveitis expected to be unresponsive to corticosteroids or uveitis unresponsive to prior corticosteroids 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 assessment will be on the ocular inflammation in the study eye as measured by vitreous haze on a standardized 0 to 4 scale 0, 0.5, 1, 2, 3, 4 . The primary efficacy analysis will be performed on the change from the baseline in vitreous haze using the ITT population. Missing data will be imputed using the last observation carried forward LOCF method. Efficacy analyses will be performed at all scheduled efficacy visits with week 8 being the primary time point for the efficacy analyses.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Piu trattamento simulato uso dell aplicatore ;
    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 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.1.3Elderly (>=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 2006-05-25. 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 90
    F.4.2.2In the whole clinical trial 189
    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 Decision2004-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-28
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