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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2009-015586-31
    Sponsor's Protocol Code Number:190342-031D
    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:2010-03-17
    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 number2009-015586-31
    A.3Full title of the trial
    A Multicenter, Masked, Randomized, Sham-Controlled, Parallel-Group, 3 Month Study with a 9-Month Safety Extension to Evaluate the Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS®) Applicator System in Improving Visual Function in Patients with a Previous Rhegmatogenous Macula-Off Retinal Detachment
    A.4.1Sponsor's protocol code number190342-031D
    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 nameBrimonidine Tartrate Posterior Segment Drug Delivery System (Brimo 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 IMPIntravitreal 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.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 nameBrimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator 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 IMPIntravitreal 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.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
    Rhegmatogenous Macula-off Retinal Detachment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10065569
    E.1.2Term Rhegmatogenous retinal detachment
    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 efficacy of the Brimo PS DDS® Applicator System (200 µg and 400 µg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment

    To evaluate the safety of the Brimo PS DDS® Applicator System (200 µg and 400 µg brimonidine tartrate) in patients with previous rhegmatogenous macula-off retinal detachment
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female age ≥ 18 years
    2. The macula-off retinal detachment (including fovea) must have been rhegmatogenous in etiology; no suspected combined mechanism is permitted in the study eye
    3. The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
    4. No evidence of macular detachment or macular edema on screening optical coherence tomography (OCT) in the study eye
    5. The best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score must be ≥ 24 letters (ie, approximately 20/320 or better) and ≤ 65 letters (ie, approximately 20/50 or worse) in the study eye at screening and Day 1 and, in the opinion of the investigator, the decreased visual acuity is due to rhegmatogenous macula-off (including fovea) retinal detachment
    6. The best-corrected ETDRS visual acuity in the non-study eye at screening is ≥ 24 letters (approximately 20/320 or better)
    7. The repair of the detachment must have been deemed an anatomic success, and must have required no more than one macular re-attachment procedure (at least 6 months before the Day 1 visit) in the study eye
    8. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate clinical evaluation of posterior pole and for adequate visualization of DDS® in the study eye
    9. 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 is surgically sterilized
    10. Written informed consent has been obtained
    11. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
    12. Written Data Protection Consent (European sites only) has been obtained
    13. Written documentation has been obtained in accordance with state and country privacy requirements, where applicable
    14. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures
    E.4Principal exclusion criteria
    1. Any sight-threatening ocular condition in the study eye other than RRD such as age-related macular degeneration, proliferative vitreo-retinopathy, moderate to severe diabetic retinopathy, epiretinal membrane or glaucoma requiring treatment that can interfere with the diagnosis or the assessment of disease progression or in the opinion of the investigator would prevent a 15-letter improvement in visual acuity
    2. Silicone oil in the vitreous cavity of the study eye
    3. Residual subretinal fluid in the macula or macular edema in the study eye by OCT or clinical exam
    4. Cataract in the study eye defined as likely to:
    a. require cataract surgery during the study or
    b. contribute to worsening BCVA during the study or
    c. prevent a 3-line improvement
    5. Aphakia or presence of anterior chamber intraocular lens in the study eye
    6. Anticipated need for ocular surgery in the study eye during the 12-month study period
    7. Any injectable, periocular, or intravitreal corticosteroid treatment to the study eye within 6 months prior to screening (eg, triamcinolone acetonide) or any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
    8. Any infectious condition in the study eye
    9. Use of brimonidine, apraclonidine, or any other topical alpha-2 agonist in the study 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. Sight-threatening disease in the non study eye
    12. Known allergy to brimonidine tartrate or any component of the delivery vehicle or diagnostic agents used during the study (eg, dilation drops).
    13. Contraindication to pupil dilation in either eye
    14. Uncontrolled systemic disease
    15. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
    16. Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient’s ability to comply with study requirements including completion of the study
    17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to the screening visit
    18. 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)
    Efficacy measures:
    Primary efficacy measure: BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] method)
    Other efficacy measures: reading speed (selected sites), Humphrey visual field (selected sites), microperimetry (selected sites), and sweep visual evoked potential (VEP) (optional at selected sites)
    Other prognostic measures: Stratus optical coherence tomography (OCT), Fourier Domain OCT (selected sites)
    Health outcome measures: vision-related quality of life (patient-reported outcomes) using the National Eye Institute 25-Item Visual Functioning Questionnaire (NEI-VFQ-25)

    Safety measures:
    Adverse events, BCVA by ETDRS, reading speed (selected sites), biomicroscopy, intraocular pressure (IOP), indirect ophthalmoscopy, vital signs (blood pressure, pulse, respiration), DDS® residual assessment
    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 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 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 No
    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 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
    Last subject last visit
    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 months2
    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 months2
    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.1.3Elderly (>=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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects have very poor vision, and may be unable to read
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3
    F.4.2.2In the whole clinical trial 44
    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)
    Once patients have exited from the study, the investigator will be responsible for either continuing their care personally (at the same hospital) or referring them back to their regular ophthalmologist. In either case, patients will be treated according to current best clinical practice with existing treatments.
    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 Decision2009-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-18
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