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    Summary
    EudraCT Number:2008-001487-37
    Sponsor's Protocol Code Number:190342-032D-01version 01
    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:2008-10-16
    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 number2008-001487-37
    A.3Full title of the trial
    A Multicenter, Masked, Randomized, Sham-controlled, Paired-eye comparison, 12-month (plus 12-month extension) study to evaluate the safety and efficacy on retinal structure and visual function of Brimonidine tartrate Posterior Segment Drug Delivery System (Brimonidine PS DDS) Applicator System in patients with Geographic Atrophy from Age-related macular degeneration.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code number190342-032D-01version 01
    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 UK 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 nameBrimo PS DDS Appllicator System
    D.3.2Product code 9741X
    D.3.4Pharmaceutical form Implant
    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 INNBrimonidine Tartrate
    D.3.9.1CAS number 70359-46-5
    D.3.9.2Current sponsor codeAGN 190342-LF
    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) 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 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 nameBrimo PS DDS Applicator System
    D.3.2Product code 9742X
    D.3.4Pharmaceutical form Implant
    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 INNBrimonidine Tartrate
    D.3.9.1CAS number 70359-46-5
    D.3.9.2Current sponsor codeAGN 190342-LF
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.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 placeboIntraocular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboImplant
    D.8.4Route of administration of the placeboIntraocular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Geographic Atrophy from 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 of the Brimo PS DDS Applicator System (200 µg and 400 µg brimonidine tartrate) in patients with geographic atrophy (GA) from age-related macular degeneration (AMD) To evaluate the effects of the Brimo PS DDS Applicator System (200 µg and 400 µg brimonidine tartrate) on retinal structure in patients with GA from AMD To evaluate the effects of the Brimo PS DDS Applicator System (200 µg and 400 µg brimonidine tartrate) on visual function in patients with GA from AMD
    E.2.2Secondary objectives of the trial
    No secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must have GA present in both eyes that is attributed to AMD. GA may be single or multi-focal and is defined as well-defined, circular areas of partial or complete depigmentation of the retinal pigment epithelium (RPE), typically with more readily visible underlying choroidal blood vessels. At the screening visit, at least one site of GA must be at least 0.75 disc area (DA) (2.02 mm2), some of which falls within a 1500 micron radius of the foveal center, and less than 12 DA (32.28 mm2) in both eyes. All sites of macular GA must be visible within 30 degree images centered on the fovea (field 2 macular photographs) without extension to the margin of these photographs. When measuring peripapillary atrophy, regardless of whether it is contiguous with any other macular areas of atrophy, draw a vertical line through the center of the optic nerve and include any atrophy on the temporal side of the vertical line.

    2. At the screening visit, the ocular media must be clear enough for good quality photographs in both eyes as determined by the investigator. Areas of GA identified on clinical examination should be visible in the fundus photographs

    3. In the treated eye, best-corrected visual acuity (BCVA) letter score between 70 (approximately 20/40 Snellen equivalent) and 25 (approximately 20/320 Snellen equivalent) inclusive as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the screening visit

    4. In the fellow eye, BCVA letter score of 25 (Snellen equivalent 20/320) or better as measured by the ETDRS method at the screening visit

    5. Man or woman, 50 years of age or older

    6. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment on Day 1. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries

    7. Written informed consent has been obtained

    8. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures

    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 the relevant country and local privacy requirements, where applicable
    E.4Principal exclusion criteria
    1. Known allergy to brimonidine tartrate or any component of the delivery vehicle or diagnostic agents used during the study (eg, fluorescein, dilation drops)
    2. Uncontrolled systemic disease 3. Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception 4. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to the screening visit 5. 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 6. Any injectable intravitreal treatment to either eye or intravitreal implant of any type in either eye within 6 months prior to the screening visit, between the screening visit and Day 1, or anticipated use during the study 7. Periocular injections of corticosteroids to either eye within 4 months prior to the screening visit or anticipated use during the study 8. Contraindication to pupil dilation in either eye 9. Use of brimonidine, apraclonidine, or any other topical alpha-2 agonist in either eye within 2 weeks prior to the screening visit or anticipated use during the study 10. Use of systemic alpha-2 antagonists (eg, phentolamine, phenoxybenzamine, yohimbine, idazoxan) or systemic alpha-2 agonists (eg, clonidine) within 2 weeks prior to the screening visit or anticipated use during the study 11. Any condition (including inability to read visual acuity, contrast sensitivity or reading speed charts or a language barrier) that precludes the patient’s ability to comply with study requirements, including completion of the study 12. Any infective condition in either eye 13. History or evidence of choroidal neovascularization in either eye based on fluorescein angiogram performed at the screening visit 14. Any ocular condition in either eye other than AMD that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study 15. Evidence of RPE abnormalities consistent with a pattern dystrophy or pseudovitelliform lesion in either eye 16. Evidence of vitreo-retinal traction maculopathy in either eye 17. History of laser or photodynamic therapy (PDT) to the macula of either eye 18. Any intraocular surgery or laser in either eye within 6 months prior to Day 1 19. GA in either eye secondary to any condition other than AMD, or secondary to drugs (eg, antimalarials)
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Measures: Primary: change in size of geographic atrophy from baseline to Month 12 based on stereoscopic color fundus photography and/or fluorescein angiography as measured by the reading center Secondary: visual acuity (BCVA by ETDRS), contrast sensitivity, reading speed, National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), Vision Preference Value Scales and Enthusiasm Questionnaire Pharmacokinetics: A single blood sample for determination of plasma brimonidine concentration will be collected on Day 1 before the treatment procedure, on Day 7, and at Months 1, 3 and 6. The samples will be collected from all patients who consent to this procedure at all clinical sites qualified for the collection and handling of pharmacokinetic samples. Plasma brimonidine concentrations will be determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with an LLOQ of 2 pg/mL. Safety Measures: Adverse events Ocular: biomicroscopy, indirect ophthalmoscopy, intraocular pressure (IOP), visual acuity (BCVA by ETDRS), and DDS residual assessment (in the treated eye) Non-ocular: blood pressure (systolic/diastolic), pulse rate, respiration rate, and urine pregnancy test
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 No
    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 Yes
    E.8.2.3Other No
    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 EEA9
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 94
    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 Decision2009-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-08
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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
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