Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-000900-15
    Sponsor's Protocol Code Number:B7A-MC-MBCU
    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:2005-05-11
    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 number2005-000900-15
    A.3Full title of the trial
    The effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients with Diabetes Mellitus, as assessed by Optical Coherence Tomography
    A.4.1Sponsor's protocol code numberB7A-MC-MBCU
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameRuboxistaurin
    D.3.2Product code LY333531
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRuboxistaurin
    D.3.9.1CAS number 169939-94-0
    D.3.9.2Current sponsor codeLY333531
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Macular Edema (DME), is the most common cause of visual impairment in patients with diabetic retinopathy (DR). It is the accumulation of extracellular fluid in the retinal tissues of the macula and is a microvascular complication of diabetes. In this study patients will have macular edema that meets the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant macular edema (CSME), (but patients with imminently vision threatening macular edema are excluded).
    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 test the hypothesis that oral administration of 32 mg per day of ruboxistaurin for approximately 24 months will reduce, relative to placebo, the baseline to endpoint changes in central macular thickness, as measured by OCT, in patients with CSME, not within 100 microns from the center of the macula at baseline.
    E.2.2Secondary objectives of the trial
    Key secondary objective:
    - Occurrence of sustained moderate visual loss (SMVL, defined as a 15 letter or more
    decrease from baseline in best-corrected ETDRS visual acuity that is sustained for the
    patient’s last 6 months of study participation). The SMVL data from this study will be
    combined with the SMVL data from Study B7A-MC-MBDL for the purpose of
    comparing ruboxistaurin to placebo. Additional secondary objectives:
    - Change from baseline to endpoint in mean retinal thickness within 500 microns of the center of the macula, as assessed by OCT.
    - Incidence and time to occurrence of significant center-involved macular edema, as assessed by OCT.
    - Change from baseline or time to occurrence in any other appropriate measures or treatments of DME or visual function, including but not limited to: photocoagulation, contrast sensitivity, and macular edema volume measures.
    - Safety and Tolerability
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Have type 1 or type 2 diabetes mellitus as defined by American Diabetes Association (ADA) and World Health Organization (WHO) criteria.
    - Have DME (based on 7-field stereoscopic fundus photogrpahs confirmed by the Fundus Photograph Reading Center) at Visit 1, showing in the study eye:
    [A] Any photographically detectable retinal thickening at or between 100 and 500 microns from the center of the macula.
    or
    [B] Retinal thickening >= 1 disc area in size, any part of which is within 100 microns from the center of the macula,
    or
    [C] Both [A] and [B].
    BUT EXCLUDING
    Retinal thickening, or hard exudates associated with adjacent retinal thickening, leass than 100 microns from the center of the macula, as noted on stereo fundus photographs.
    - Have, in the study eye, a DR level corresponding to ETDRS retinopathy score >=35b and <=53e, as determined by 7-field stereoscopic fundus photographs as confirmed by the Fundus Photograph Reading Center.
    - Have, in the study eye, a best-corrected visual acuity of at least 75 letters on the ETDRS visual acuity chart.
    - Male or female, aged 18 years or older at Visit 1.
    - Have and HbA1c value <=11.0% at Visit 1.
    - Have seated BP<= 160/90 mmHg, as determined by the mean of three separate resting measurements at Visit 1. Patients with a BP above this limit may be re-screened 1 month later.
    E.4Principal exclusion criteria
    - Retinal thickening, or hard exudates associated with adjacent retinal thickening, less than 100 microns from the center of the macula, noted on stereo fundus photographs in the study eye at Visit 1.
    - Have had previous photocoagulation for DR and/or DME in the study eye prior to Visit 1.
    - Are likely to require focal/grid or pan-retinal (scatter) photocoagulation in the study eye within 3 months of study randomization, in the opinion of the investigator, at Visit 1.
    - Have tractional DME, thickened taut posterior hyaloid membrane, or cystoid changes in the study eye, in the opinion of the investigator, as determined by OCT.
    - Have had intra-ocular surgery, e.g. cataract extraction, within 6 months of visit 1, and/or anticipated intra-ocular surgery during the study, in the opinion of the investigator, in the study eye.
    - Have an occludable anterior chamber angle or open angle glaucoma in the study eye, in the opinion of the investigator, at Visit 1. Ocular hypertension in the absence of a glaucomatous visual field defect is not an exclusion criterion.
    - Have current vitreous or pre-retinal hemorrhage in the study eye at Visit 1.
    - Have eccentric or imperfect fixation in the study eye at Visit 1.
    - Have a history of conditions in the study eye at Visit 1 which, in the opinion of the investigator, might affect macular edema, alter visual acuity, or confound stereoscopic fundus photography or OCT readings, including but not limited to: intra-ocular surgery, significant chorioretinal scars, optic atrophy, retinal degeneration, retinal vein occlusion, retinal artery occlusion, rubeosis iridis, pathologic myopia, age-related macular degeneration, posterior uveitis, branch vein or artery occlusion.
    - Are unable to provide adequate OCT readings or fundus photography at Visit 1 ( as assessed by the reading center) for reasons including but not limited to: media opacity or compliance.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the change from baseline to endpoint in absolute retinal thickness at the center of the macula, as determined by OCT.
    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 Information not present in EudraCT
    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) 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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    The end of study will be the Month 24 visit completed by the last patient active in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-05-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 191
    F.4.2.2In the whole clinical trial 300
    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 Decision2005-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-14
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 05 21:56:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA