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    Summary
    EudraCT Number:2013-004567-30
    Sponsor's Protocol Code Number:1313.20
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-24
    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 number2013-004567-30
    A.3Full title of the trial
    A single arm open label study to evaluate the pharmacodynamics and safety of a 4 wk treatment with BI 144807 in patients with newly diagnosed wet age related macular degeneration (wAMD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 4 week study with BI 144807 in patients >= 50 years with wet age related macular degeneration
    A.4.1Sponsor's protocol code number1313.20
    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 SponsorBoehringer Ingelheim Pharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co.KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBI 144807
    D.3.2Product code BI 144807
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNBI 144807
    D.3.9.3Other descriptive nameBI 144807
    D.3.9.4EV Substance CodeSUB91871
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed unilateral wet age-related macular degeneration (wAMD)
    E.1.1.1Medical condition in easily understood language
    A medical condition that results in a loss of vision in the center of the visual field because of damage to the retina caused by new blood vessel growth in the eye; usually affects older adults
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10067791
    E.1.2Term Wet macular degeneration
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the current study is to investigate the effect of BI 144807 treatment on central retinal thickness in patients with wAMD as assessed by spectral domain-optical coherence tomography (SD-OCT)
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    i) effect of BI 144807 on neovascular leakage as assessed by fluorescein angiography
    ii) presence of intraretinal fluid, subretinal fluid, and pigmented epithelial detachment
    iii) changes in visual acuity from baseline
    iv) safety in patients with wAMD
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    i) Pharmakokinetic substudy (31.01.2014 Version 1): Concentrations of BI 144807 in the ocular aqueous humour and in plasma will be determined to allow for exploratory pharmacokinetic/pharmacodynamic correlations to efficacy parameters.
    ii) Pharmakogenetic substudy (31.01.2014 Version 1): DNA banking for exploratory genotyping to analyze disease or treatment-related gene variants
    E.3Principal inclusion criteria
    1. Men and women with newly diagnosed unilateral active choroidal neovascularization secondary to AMD
    2. No prior treatment for neovascular AMD in the study eye and no current or planned concomitant intravitreal anti-vascular endothelial growth factor treatment in the fellow eye
    3. Central subfield retinal thickness ≥ 250 µm
    4. Presence of sub- and/or intraretinal fluid on SD-OCT
    5. Any active CNV with subfoveal leakage
    6. Total lesion size not greater than 12 disc areas
    7. No subretinal hemorrhage involving the fovea, if the size of hemorrhage is > 50% of the total lesion area
    8. No subfoveal fibrosis or atrophy
    9. Best-corrected ETDRS visual acuity in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 and 4/63) at screening
    10. Patients 50 years of age or older
    11. Female subjects must be of non-childbearing potential
    E.4Principal exclusion criteria
    1. Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
    2. The presence of polypoidal choroidal vasculopathy or retinal angiomatous proliferation in the study eye
    3. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation
    4. Intraocular surgery in the study eye within 3 months prior to screening
    5. Aphakia or total absence of the posterior capsule in the study eye
    6. Known allergy to fluorescein sodium for injection
    7. Current or planned use of medications known to be toxic to the retina, lens or optic nerve
    8. Medical history or condition: Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, concomitant use of warfarin or anticoagulation therapy, major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension
    9. Planned concomitant use of strong CYP 3A4 or P-gp inhibitors or inducers during the study
    10. Planned concomitant use of P-gp substrates, that are narrow therapeutic index drugs
    11. Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose or known diseases which could require the use of systemic steroids within the study period
    12. Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria. AST or ALT greater than 2.0-fold the upper limit of normal at screening. Patients with total bilirubin TB or INR> 1.5 x upper limit of normal at screening.
    13. Patient with impaired renal function defined as calculated GFR< 30 mL/min
    14. Significant alcohol or drug abuse within past 2 years
    15. Based on central ECG reading, patients with a risk of prolonged QT interval effects
    16. Significant disease or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:
    • Put the patient at risk because of participation in the study,
    • Influence the results of the study,
    • Cause concern regarding the patient’s ability to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in central retinal thickness as measured by SD-OCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 4 weeks
    E.5.2Secondary end point(s)
    • Change in neovascular leakage by fluorescein angiography from baseline
    • Visual Acuity determined with letter charts over time, absolute and as change from baseline;
    • Vascular area determined with cyanine green angiography, absolute and as change from baseline;
    • Central 1mm retinal thickness over time, absolute and as change from baseline;
    • Neovascular leakage area as assessed by fluorescein angiography over time, absolute and as change from baseline;
    • Presence and height of intra-retinal fluid by SD-OCT over time, absolute and as change from baseline;
    • Presence and height of sub-retinal fluid by SD-OCT over time, absolute and as change from baseline;
    • Presence and height of pigment epithelial detachment by SD-OCT over time, absolute and as change from baseline;
    • Safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 (Baseline); Day 8 (week 1); Day 15 (week 2); Day 22 (week3); Day 29 (week 4)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    After study participation subjects will be treated with the standard of medical care therapy.
    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 Decision2014-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-04-15
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