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    Summary
    EudraCT Number:2006-004626-93
    Sponsor's Protocol Code Number:TG-MV-002
    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:2006-12-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-004626-93
    A.3Full title of the trial
    A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Diabetic Macular Edema.
    A.3.2Name or abbreviated title of the trial where available
    MIVI II
    A.4.1Sponsor's protocol code numberTG-MV-002
    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 N.V.
    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-P07-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-P07-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
    Diabetic macular edema
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    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 several doses of intravitreal microplasmin in patients with diabetic macular edema.
    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 > or = 18
    II. Patients with DME involving the center of the macula with a macular thickness (in the central subfield on OCT) of greater than 275 microns in the study eye
    III. No evidence in study 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 20/32 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 fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion) in the study eye
    II. Evidence of foveal ischemia (foveal avascular zone: longest diameter > 1,000 microns) or dense, hard exudates beneath the fovea
    III. Evidence of complete macular PVD in study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection
    IV. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye
    V. 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
    VI. 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.
    VII. Patients with high myopia (axial length > 26.0 mm on A-scan ultrasound) or aphakia in the study eye
    VIII. Patients with history of rhegmatogenous retinal detachment in the fellow eye
    IX. Patients who are considered likely to require intraocular surgery in either eye for any reason in the next three months
    X. Patients who have had ocular surgery in the study eye in the prior three months
    XI. Patients who have had a vitrectomy in the study eye at any time.
    XII. 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
    XIII. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months
    XIV. Intravitreal injection of any drug in the study eye in the previous 3 months
    XV. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator
    XVI. Patients who in the investigators view will not complete all visits and investigations, including the last double-masked visit at 6 months
    XVII. Patients who have participated in an investigational drug study within the past 30 days
    XVIII. Patients with poor glycemic control according to the Investigator
    XIX. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg)
    XX. Patients with a life expectancy less than 6 months
    XXI. Patients who have previously participated in this trial
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY EVALUATIONS/CRITERIA

    Primary efficacy endpoint:

    • Proportion of patients with total PVD (i.e. vitreous detachment to the equator) as determined by masked, Central Reading Center evaluation at day 14 visit imaging (4-quadrant US and OCT)
    (Central Reading Center representative: Prof. Dr. M. Ulbig, Munich, Germany)

    Secondary efficacy endpoint:
    • 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
    • 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 alternative therapy
    • Maintenance or gain in vision (no change in number of letters or a gain of one or more letters from baseline)
    • Moderate visual loss (decrease from baseline of >= 15 letters, i.e. 3 lines), sustained moderate visual loss (moderate visual loss at each of two consecutive visits 3 or more months apart) and severe visual loss (decrease from baseline of >= 30 letters, i.e. 6 lines) and time to moderate, sustained moderate and severe visual loss
    • VFQ-25
    • Need for alternative therapy (either intravitreal drug administration, laser photocoagulation, or vitrectomy)
    • Progression of DR severity (Masked Central Reading Center): >= 2 step progression; >= 3 step-progression; time to >= 2 step progression; time to >= 3 step-progression

    All of the above secondary endpoints will be evaluated at all visits in which the underlying assessments are performed.

    SAFETY EVALUATIONS/CRITERIA

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

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

    *According to criteria defined as follows:
    - for anterior chamber and vitreous inflammation grading, use scales defined in Appendix 6
    - 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 Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    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 EEA13
    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 the trial is defined as the last visit of the last subject, unless the Safety Committee recommends premature termination of the trial as result of safety concerns.
    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 days0
    E.8.9.2In all countries concerned by the trial years3
    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 2006-12-11. 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 state20
    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 Decision2006-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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