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    The EU Clinical Trials Register currently displays   43857   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:2007-004416-31
    Sponsor's Protocol Code Number:206207-016
    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:2008-02-21
    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 number2007-004416-31
    A.3Full title of the trial
    A 6-Month, Single-Masked, Multicenter, Randomized, Controlled Study to Assess the Safety and Efficacy of 700 μg Dexamethasone Posterior Segment Drug Delivery System Applicator System as Adjunctive Therapy to Lucentis® Compared with Lucentis® Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
    A.4.1Sponsor's protocol code number206207-016
    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 nameDexamethasone Posterior Segment Drug Delivery System (DEX 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 RoleComparator
    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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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.3.4Pharmaceutical form Solution for injection
    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 INNRanibizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Choroidal neovascularization secondary to age-related macular degeneration
    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 DEX as adjunctive therapy to Lucentis® (hereafter referred to as “Adjunctive Therapy”) compared with sham DEX plus Lucentis® (hereafter referred to as “Lucentis Alone”) in subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 50 years
    2. In the study eye, subfoveal CNV secondary to AMD as evaluated by the investigator based on clinical examination and fluorescein angiography, with a total lesion size (including blood, scar/atrophy, and neovascularization) of ≤ 12 MPS (Macular Photocoagulation Study) disc areas (30.48 mm2), of which at least 50% has to be active CNV (classic or occult) at the screening visit
    3. In the study eye, best-corrected visual acuity (BCVA) score ≥ 19 and ≤ 69 letters (approximately 20/400 and 20/40 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the screening visit
    4. Patient requires Lucentis® treatment in the opinion of the investigator.
    5. Written informed consent has been obtained
    6. Written authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
    7. Written Data Protection Consent (European sites only) has been obtained
    8. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
    9. Ability to follow study instructions and likely to complete all required visits and procedures
    E.4Principal exclusion criteria
    OCULAR EXCLUSION CRITERIA
    Study Eye
    1. Presence of any subfoveal scarring, fibrosis, or atrophy
    2. Any significant ocular disease other than CNV due to AMD that could compromise vision and/or confound interpretation of the data
    3. Presence of any causes of CNV such as pathologic myopia (spherical equivalent of –8 diopters or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis
    4. Retinal pigment epithelium tear that includes the fovea as determined by fluorescein angiography (FA) at the screening or baseline visit
    5. Significant media opacities (including cataract), inability to dilate pupil, or lack of patient cooperation that, in the opinion of the investigator, might interfere with the patient’s ocular evaluations
    6. Aphakia or presence of anterior chamber intraocular lens
    7. Prior pars plana vitrectomy
    8. Elevated intraocular pressure (IOP) at the screening or baseline visit
    9. Previous or anticipated concomitant therapy:
    9.1 Cohort 1
    a) Any previous treatment for AMD
    9.2 Cohort 2
    a) Foveal thermal laser treatment for AMD within 3 month prior to the screening visit
    b) PDT treatment for AMD within 3 months prior to the screening visit
    c) Intraocular treatment with Lucentis®, Avastin®, or Macugen® within 6 weeks prior to the screening visit
    d) Use of topical ophthalmic corticosteroids or topical ophthalmic nonsteroidal drugs within 4 weeks prior to the screening visit
    e) History of any intravitreal triamcinolone acetonide injection unless the most recent dose was more than 3 months prior to the screening visit and each dose was ≤ 4 mg
    f) Any intravitreal or periocular dexamethasone injection within 3 months prior to the screening visit
    g) Periocular depot corticosteroid injection within 6 months prior to the screening visit
    h) If corticosteroids were previously administered, there were no corticosteroid or injection-related complications that would be expected to recur with repeated intravitreal corticosteroid administration.
    i) Recent (within 30 days prior to screening) or anticipated use of investigational multivitamins or trace minerals.
    10. Any intraocular surgery (including cataract surgery and/or laser of any type) within 3 months prior to the screening visit
    11. Anticipated need for ocular surgery or laser treatment during the study period
    12. History of herpetic infection in the study eye or adnexa
    13. Presence of visible scleral thinning or ectasia at the screening or baseline visit as determined by biomicroscopy
    Either Eye
    14. Diabetic retinopathy
    15. Active ocular infection (bacterial, viral, parasitic, or fungal) at the screening or baseline visit
    16. Glaucoma, optic nerve head change consistent with glaucoma, or visual field loss consistent with glaucoma.
    17. History of IOP elevation in response to steroid treatment that resulted in either of the following:
    a) IOP increase of ≥ 10 mm Hg and an absolute IOP ≥ 25 mm Hg, both attributed to the use of steroid treatment
    b) Required surgery, laser, or more than 1 medication to lower IOP
    18. Contraindication to pupil dilation
    19. History of central serous chorioretinopathy
    20. Presence of active or inactive toxoplasmosis
    NON-OCULAR EXCLUSION CRITERIA
    21. History or current uncontrolled systemic disease at the screening or baseline visits
    22. Myocardial infarction or stroke within 12 months prior to the baseline visit
    23. Any major surgical procedure within 1 month prior to the screening visit or during the screening period
    24. Known allergy or hypersensitivity to the study medication or its components
    25. Known allergy or contraindication to the use of fluorescein
    GENERAL EXCLUSION CRITERIA
    27. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception for at least 1 month prior to the screening visit and for the duration of the study
    28. Any condition (including inability to read visual acuity charts or language barrier) that precludes the patient’s ability to comply with study requirements including completion of the study
    29. Patients who are planning for an extended absence away from the immediate area of the study center that would preclude them from returning for all protocol-specified study visits
    30. Current enrollment in an investigational drug or device study or participation in such a study within 1 month prior to the screening visit
    31. Previous enrollment in a DEX clinical trial
    32. 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the time from the second Lucentis® injection (Day 7 to Day 14) to the determination of eligibility to receive a third Lucentis® injection. For those not requiring a third injection or for those who discontinued the study prematurely (prior to determination of eligibility to receive a third injection), the primary efficacy variable is the time between the second injection and the exit visit.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 years1
    E.8.9.1In the Member State concerned months1
    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 months1
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 200
    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 Decision2007-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-08
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    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.

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