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    The EU Clinical Trials Register currently displays   33890   clinical trials with a EudraCT protocol, of which   5493   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-003661-17
    Sponsor's Protocol Code Number:SS01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-24
    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 number2012-003661-17
    A.3Full title of the trial
    A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed versus PRN dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patients with refractory diabetic macular oedema.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed versus Variable dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patients with refractory diabetic macular oedema.
    A.3.2Name or abbreviated title of the trial where available
    OZDRY
    A.4.1Sponsor's protocol code numberSS01
    A.5.4Other Identifiers
    Name:R&D referenceNumber:SIVS1002
    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 SponsorMoorfields Eye Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAllergan Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMoorfields Eye Hospital
    B.5.2Functional name of contact pointNatasha Ajraam
    B.5.3 Address:
    B.5.3.1Street Address162, City Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1V 2PD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 7253 3411 x2937
    B.5.5Fax number02075662315
    B.5.6E-mailnatasha.ajraam@moorfields.nhs.uk
    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 Yes
    D.2.1.1.1Trade name OZURDEX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOZURDEX
    D.3.4Pharmaceutical form Intravitreal implant in applicator
    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.3.9.3Other descriptive nameOzurdex
    D.3.9.4EV Substance CodeAS1
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic macular oedema
    E.1.1.1Medical condition in easily understood language
    diabetes related swelling of the central retina
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    Is OCT-guided PRN dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)in patients with refractory DMO non-inferior to 5 monthly fixed dosing of this drug in terms of visual acuity outcomes?
    E.2.2Secondary objectives of the trial
    1. To evaluate the effects of PRN dosing relative to fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) on patient reported outcomes in patients with refractory DMO
    2. To evaluate the safety of PRN dosing relative to fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patients with refractory DMO.
    3. To evaluate the effects of PRN dosing relative to fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) on anatomical changes in patients with refractory DMO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects of either sex aged 18 years or over
    2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considere to be sufficient evidence that diabetes is present:
    i. Current regular use of insulin for the treatment of diabetes
    ii. Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes
    iii. Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes)
    3. Best corrected visual acuity in the study eye between ≥34 and ≤73 ETDRS letters at 1m at baseline attributable to DMO.
    4. On clinical exam at baseline in the study eye, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield > 300 microns (Spectralis) despite previous therapy.
    5. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
    6. Ability to return for study visits
    7. Visual acuity in fellow eye ≥ 2/60
    8. Ability to give informed consent throughout the duration of the study
    E.4Principal exclusion criteria
    The following exclusions apply to the study eye only (i.e. they may be present for the non study eye, provided that inclusion criterion 8 is met):
    1.Macular ischaemia (FAZ > 1000µm in diameter or severe perifoveal intercapillary loss on IVFA).
    2.Macular oedema is considered to be due to a cause other than diabetic macular oedema. An eye should not be considered eligible if: (1) the macular oedema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal embrane) is the primary cause of the macular oedema.
    3.Co-existent ocular disease: An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular oedema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non retinal conditions, such as amblyopia).
    4.An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, etc).
    5.A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).
    6.History of treatment for DMO with peribulbar or intravitreal steroids in the study eye in the past 6 months.
    7. History of macular laser in study eye in the last 3 months.
    8. History of antiVEGF therapy within the last 1 month.
    9. Active proliferative diabetic retinopathy or rubeosis in the study eye at baseline. (Stable and treated proliferative diabetic retinopathy may be included).
    10. A condition that, in the opinion of the investigator, would preclude participation in the study.
    11. A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
    12.. Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
    13. Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study.
    14. Pregnant or lactating women or women intending to become pregnant within the study period.
    15. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomisation.
    16. Aphakia
    17. A diagnosis of glaucoma which in the opinion of a glaucoma specialist is at high risk of progression or ocular hypertension requiring at least one topical medication.
    19. History of vitrectomy in study eye.
    20. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or severe blepharitis. If treated these subjects can be included.
    21. Known allergy to fluorescein dye or to any component of the study drug.
    22. Fertile male unwilling to use contraception for the duration of the study
    Contraceptive advice to women of child-bearing age and fertile males
    Women of child-bearing potential will be advised to use contraception for the duration of the study. They will be advised not to deliberately become pregnant during the trial and use contraception for 3 months after the study concludes. Women who become pregnant during the trial will have the study drug immediately discontinued and will be withdrawn from the trial. Fertile males will be advised to use contraception for the duration of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is the difference between arms in the change from baseline in best corrected visual acuity at 12 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    1. Difference between arms in proportion of patients with improvement of BCVA (gain of 10 ETDRS letters or more)
    2. Difference between arms in proportion of patients with stabilization of BCVA (loss of less than 15 ETDRS letters)
    3. Difference between arms in change from baseline in central retinal thickness as measured by OCT
    4. Difference between arms in change from baseline in each domain and composite scores of the National Eye Institute Visual function questionnaire (VFQ-25), RetTSQ and RetDQoL.
    5. Difference between arms in changes in morphological characteristics of diabetic macular oedema on OCT.
    6. Difference between arms in proportion of patients with decrease in leakage on FFA, foveal avascular zone parameters and ETDRS grade of retinopathy at month 12.
    7. Difference between arms in number of treatments.
    8. Difference between arms in changes in distribution of BCVA change from baseline in 5 categories: a) ≥15 letters improvement b) ≥ 5 letters and < 15 letter improvement c) no change (i.e. ≥ -4 and ≤4 letters d) ≥5 letters and <15 letters worsening and e) ≥15 letters worsening.
    9. Difference between arms in adverse events.
    Further exploratory analyses may be done as new data emerges.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 Yes
    E.8.1.3Single blind Yes
    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
    Ozurdex 5 monthly dosing
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Following completion of trial followup,subjects will continue to be treated in the Medical Retina Service at each site. If they have ongoing diabetic macular oedema requiring treatment, they will be able to receive laser or antiVEGF treatment for this irrespective of which arm of the trial they had been randomised to. There is no contraindication to receiving laser or antiVEGF treatment after Ozurdex therapy.There is no funding in place to supply Ozurdex to these participants post-trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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