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    Summary
    EudraCT Number:2013-003320-36
    Sponsor's Protocol Code Number:190342-038
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-003320-36
    A.3Full title of the trial
    Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON Study)
    A.4.1Sponsor's protocol code number190342-038
    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 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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Ltd. EU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 494444
    B.5.5Fax number+44 1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    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 nameBrimonidine free base
    D.3.2Product code AGN-190342
    D.3.4Pharmaceutical form Implant
    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 INNBrimonidine free base
    D.3.9.2Current sponsor codeAGN-190342
    D.3.9.3Other descriptive nameBrimonidine free base
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8.3Pharmaceutical form of the placeboImplant
    D.8.4Route of administration of the placeboIntravitreal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Geographic Atrophy Secondary to Age-related Macular Degeneration
    E.1.1.1Medical condition in easily understood language
    Geographic Atrophy Secondary to Age-related Macular Degeneration
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025409
    E.1.2Term Macular degeneration
    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
    The study objectives are to assess: (1) the safety of the treatment; (2) the effects of treatment
    on the mean change in atrophic lesion area quantified from fundus autofluorescence images;
    (3) the effects of treatment on the mean change in low luminance best corrected visual acuity (BCVA);
    (4) the effects of treatment on the mean change in standard BCVA;
    (5) the effects of treatment on the mean change in retinal sensitivity quatified using scotopic/mesopic microperimetry;
    (6) to characterize the systemic pharmacokinetic profile of Brimo DDS.
    E.2.2Secondary objectives of the trial
    None.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients 55 years of age or older as assessed at Screening Visit 1
    The study eye must have:
    • Diagnosis of GA secondary to AMD, as assessed with fundus autofluorescence (FAF) at Screening Visit 1 and confirmed by the central reading center (CRC); these atrophic areas consist of funduscopically visible discrete areas characterized by a marked decrease in fundus autofluorescence intensity and loss of outer-retinal layers with choroidal signal enhancement as assessed with SD-OCT.
    Areas of atrophy must be multifocal lesions that contain all of the following characteristics:
    - At least one focal lesion must be equal to or larger than 0.2 mm2
    - The total lesion area must be greater than 1.25 mm2, but not larger than 18 mm2
    - The presence of banded or diffuse perilesional hyper-autofluorescence evident on fundus autofluorescence examination.
    - The distance between the optic disc or peripapillary atrophy and any atrophic lesion must be greater than 300 μm
    • Presence of drusen, yellow or white accumulations of extracellular material formed between Bruch's membrane and the retina pigmented epithelial cell layer, assessed with fundus photography and/or SD-OCT at Screening Visit 1 and confirmed by the CRC
    - BCVA better than or equal to 45 letters (20/125 Snellen equivalent) at Screening Visit 1 and the Baseline visit as assessed using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity protocol
    - Clear ocular media and adequate pupil dilation to permit good quality retinal imaging as assessed at Screening Visit 1 and confirmed by the CRC
    - For patients participating in microperimetry assessments: abitity to complete repeat assessments of scotopic/mesopic microperimetry with an intra-visit, mean, retinal sensitivity reproducibility of 6 dB or less, as assessed at Screening Visit 2 and confirmed by the CRC
    • The Fellow Eye must have Standard BCVA of 34 letters (Snellen equivalent 20/200) or better at Screening Visit 1
    E.4Principal exclusion criteria
    • History or evidence of choroidal neovascularization in either eye at Screening Visit 1, as confirmed by the CRC
    • Diagnosis of GA secondary to AMD that presents as unifocal atrophic lesions, lesions with no perilesional hyper-autofluorescence, lesions with only focal areas of perilesional hyper-autofluorescence on FAF examination of the study eye at Screening Visit 1 and confirmed by the CRC
    • Spherical equivalent of the refractive error of -6 diopters of myopia or worse (prior to cataract or refractive surgery) in the study eye at Screening Visit 1
    E.5 End points
    E.5.1Primary end point(s)
    Atrophic lesion area as assessed with fundus autofluorescence and quantified by the
    CRC
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months following the first treatment.
    E.5.2Secondary end point(s)
    • Retinal sensitivity as assessed with scotopic/mesopic microperimetry
    • Low luminance BCVA as assessed using a 2.0 log unit neutral density filter and the
    ETDRS visual acuity protocol
    • Standard BCVA assessed using the ETDRS visual acuity protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months following the first treatment.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Genotyping and gene expression will also be performed.
    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) 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 No
    E.8.1.4Double blind Yes
    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 Study Treatment
    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 concerned2
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    France
    Germany
    Italy
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 320
    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)
    Standard of care.
    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 Decision2014-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-30
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