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    Summary
    EudraCT Number:2005-001171-36
    Sponsor's Protocol Code Number:TG-MV-001
    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:2005-06-30
    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 number2005-001171-36
    A.3Full title of the trial
    A Dose-Escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
    A.3.2Name or abbreviated title of the trial where available
    MIVI
    A.4.1Sponsor's protocol code numberTG-MV-001
    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 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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vitreomacular Traction Maculopathy
    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 evaluate the safety and preliminary efficacy of two doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    INCLUSION CRITERIA

    i. Male or female patients aged 18 to 80 years inclusive.
    ii. Patients with vitreomacular traction maculopathy for whom vitrectomy is
    indicated according to the principal investigator, including:
    o Macular edema associated with vitreomacular traction (DME, VMTS)
    o Stage II-III macular hole of < 6 months duration since symptom onset
    iii Demonstration of vitreomacular adhesion (based on preoperative OCT) in the
    study eye
    o OCT - presence of posterior hyaloid membrane inserting on to the macula, but
    with some area of clear separation visible between the retina and the posterior
    hyaloid
    iv Written informed consent obtained from the patient prior to inclusion in the study
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA

    i. Evidence of fibrocellular proliferation characterized by whitish epimacular tissue
    (Surface wrinkling is not an exclusion criterion).
    ii. 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.
    iii. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative
    changes in the study eye.
    iv. Patients with high myopia or aphakia in the study eye
    v. Patients with history of,rhegmatogenous retinal detachment in the fellow eye or
    family history of retinal detachment
    vi. Patients who are considered likely to require intraocular surgery in the study eye
    for any reason other than vitreomacular traction maculopathy/macular edema in
    the coming three months.
    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 a history of uveitis or significant trauma in the study eye.
    x. Patients who are currently being treated for glaucoma in the study eye.
    xi. Patients who have had laser photocoagulation treatment in the study eye in the
    previous 3 months.
    xii. Intravitreal injection of any drug in the study eye in the previous 6 months or
    during the study.
    xiii. Patients who are pregnant or of child-bearing potential not utilizing a form of
    contraception acceptable to the Investigator.
    xiv. Patients who in the investigators view will not complete all visits and
    investigations, including the exit visit at 6 months.
    xv. Patients who have participated in an investigational drug study within the past
    30 days.
    xvi. HgA1c > 9%.
    xvii. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg).
    xviii. Patients with a life-expectancy less than 6 months.
    xix. Patients who have previously participated in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    STUDY ENDPOINTS

    EFFICACY EVALUATIONS/CRITERIA

    Primary efficacy endpoint

    · PVD induction preoperatively, i.e. release of vitreomacular traction (assess by OCT)
    · Ease of induction of PVD at the beginning of vitrectomy (as assessed by operator)

    Secondary efficacy endpoints

    · Extent and speed of resolution of macular edema (as assessed by macular
    thickness on OCT and fluorescein angiogram).
    · Post-operative best corrected visual acuity (BCVA) at 1, 2 and 4 weeks and 3 and
    6 months.

    SAFETY EVALUATIONS/CRITERIA

    · Post-operative complications (including worsening visual acuity, worsening macular
    edema, vitreous hemorrhage, retinal tear or detachments, other reasons for
    reoperation, inflammation [presence, severity, location]*, IOP alterations, cataract
    formation*, visual field alterations [based on Goldmann or Humphrey 30-1
    perimetry])
    · ERG/ VEP/ EOG pre and post injection/surgery.
    · Fluorescein angiography to assess for leakage from vessels
    · OCT
    *According to criteria defined as follows:
    - for cataract grading, use LOCS III grading system

    ADDITIONAL EVALUATIONS

    · Routine laboratory assessments (haematology, clinical chemistry, urinalysis)
    · Histopathology on ILM/epiretinal membrane samples
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    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 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 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 the 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 2005-06-30. 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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 the 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 Decision2005-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
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