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    Summary
    EudraCT Number:2006-006085-42
    Sponsor's Protocol Code Number:TG-MV-004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-006085-42
    A.3Full title of the trial
    A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding, Multicenter Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Vitreomacular Traction
    A.3.2Name or abbreviated title of the trial where available
    MIVI II-TRACTION
    A.4.1Sponsor's protocol code numberTG-MV-004
    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 SponsorThromboGenics Ltd.
    B.1.3.4CountryIreland
    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 nameMicroplasmin
    D.3.2Product code M-PLA-P08-REC-FOR/1.875-a
    D.3.4Pharmaceutical form Solution for injection
    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 INNMicroplasmin
    D.3.9.2Current sponsor codeM-PLA-P08-REC-FOR/1.875-a
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vitreomacular Traction Syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10051065
    E.1.2Term Vitreomacular traction syndrome
    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 and preliminary efficacy of 4 doses of intravitreal microplasmin in patients with vitreomacular traction
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I. Male or female patients aged >= 18
    II. Patients with a partial central PVD, but with vitreous still attached on the foveal area (documented on OCT and/or ultrasound) causing secondary macular edema (>= 250 µm in either the central subfield on OCT or measured on one of the individual radial scans of the macular area)
    III. No evidence in either eye of complete macular PVD (on biomicroscopy, B-scan or OCT), i.e. attached posterior hyaloid or incomplete PVD with vitreomacular adhesions
    IV. BCVA of 20/40 or worse in study eye
    V. BCVA of 20/400 or better in the contralateral eye
    VI. Written informed consent obtained from the patient prior to inclusion in the study
    E.4Principal exclusion criteria
    I. Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection
    II. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye
    III. Patients with vitreous hemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
    IV. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes associated with increased risk of retinal detachment in the study eye. Such retinal degenerative changes include lattice degeneration or cystic retinal tufts. Thorough retinal examination should be performed in all patients to rule out these changes.
    V. Patients with high myopia (axial length > 26.0 mm on A-scan ultrasound) or aphakia in the study eye
    VI. Patients with history of rhegmatogenous retinal detachment in the fellow eye
    VII. Patients who have had ocular surgery in the study eye in the prior three months
    VIII. Patients who have had a vitrectomy in the study eye at any time.
    IX. Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss, documented by perimetry, in the study eye
    X. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months
    XI. Intravitreal injection of any drug in the study eye in the previous 3 months
    XII. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator
    XIII. Patients who, in the investigators view, will not complete all visits and investigations, including the last double-masked visit at 6 months
    XIV. Patients who have participated in an investigational drug study within the past 30 days
    XV. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg)
    XVI. Patients with a life expectancy less than 6 months
    XVII. Patients who have previously participated in this trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Proportion of patients with total PVD (ie, vitreous detachment to the equator) as determined by masked Central Reading Center evaluation of the day 14 visit imaging after each injection (4-quadrant B-scan and OCT)

    Secondary efficacy endpoints:
    • Proportion of patients with total PVD as determined by masked Central Reading Center evaluation of imaging (4-quadrant US and OCT) from study visits other than the day 14 post-injection visit after each injection
    • Proportion of patients requiring additional treatment (vitrectomy)
    • ME resolution (change from baseline in macular thickness in the central subfield; central foveal thickness [mean thickness at the point of intersection of the 6 radial scans]; and macular volume on OCT)
    • Change in BCVA
    • Achievement of >= 2 and >= 3 lines improvement in BCVA without need for alternative therapy (i.e. intravitreal drug injection, laser photocoagulation, or vitrectomy) and time to >= 2 and >= 3 lines improvement in BCVA without need for vitrectomy
    • VFQ-25

    Safety Evaluations / Criteria:

    The safety profile of the different treatment regimens will be assessed based on:

    I. Post-injection complications (including worsening visual acuity, worsening macular edema, vitreous hemorrhage, retinal tear or detachments, inflammation [presence, severity, location]*, IOP alterations, cataract formation*
    II. Fluorescein angiography to assess for leakage from vessels
    III. OCT

    *According to criteria defined as follows:
    - for anterior chamber and vitreous inflammation grading, use scales defined in Appendix 6 of the protocol
    - for cataract grading, use LOCS III grading system
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sham injection
    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 EEA4
    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 Information not present in EudraCT
    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
    The end of trial is defined as the last visit of the last subject, unless the Safety Committee recommends premature termination of the trial as a result of safety concerns
    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 months0
    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 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 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 Yes
    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 2007-01-16. Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Normal treatment of condition
    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 Decision2007-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
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