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    Summary
    EudraCT Number:2012-004078-24
    Sponsor's Protocol Code Number:TAPAS
    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:2013-01-22
    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 number2012-004078-24
    A.3Full title of the trial
    Intravitreal Tissue Plasminogen Activator (tPA), Perfluoropropane (C3F8), and Ranibizumab for Neovascular Age-Related Macular Degeneration and Submacular Haemorrhage (TAPAS): A Randomized, Double-Masked, Controlled, Factorial, Feasibility Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of a clot dissolving drug and gas, injected into the eye, to treat bleeding associated with wet age-related macular degeneration
    A.3.2Name or abbreviated title of the trial where available
    TAPAS Study
    A.4.1Sponsor's protocol code numberTAPAS
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing's Health Partners R&D Challenge fund (Guy's and St Thomas' Charity)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointTim Jackson
    B.5.3 Address:
    B.5.3.1Street AddressKing's College NHS Foundation Trust, Denmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203299 1297
    B.5.5Fax number00440203299 1721
    B.5.6E-mailt.jackson1@nhs.net
    B.Sponsor: 2
    B.1.1Name of SponsorKing's College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing's Health Partners R&D Challenge fund (Guy's and St Thomas' Charity)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointTim Jackson
    B.5.3 Address:
    B.5.3.1Street AddressDenmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203299 1297
    B.5.5Fax number00440203299 1721
    B.5.6E-mailt.jackson1@nhs.net
    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 Yes
    D.2.1.1.1Trade name Actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameActilyse
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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 INNALTEPLASE
    D.3.9.1CAS number 105857-23-6
    D.3.9.4EV Substance CodeSUB05378MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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 Yes
    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
    Sub-macular haemorrhage secondary to wet macular degeneration
    E.1.1.1Medical condition in easily understood language
    Significant bleeding under the retina that has occurred because of abnormally weak blood vessels that are present in wet age-related macular degeneration
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10067791
    E.1.2Term Wet macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if intravitreal tissue plasminogen activator (tPA), gas (C3F8) and ranibizumab promote the resolution of submacular haemorrhage (SMH) due to neovascular (wet) age-related macular degeneration, and improve the visual outcome. The primary outcome measure will be the change in mean ETDRS visual acuity at 3 months following treatment.

    [Lay notes: ETDRS visual acuity is vision assessed using a specialized eye chart.Please see the lay summary for the other clinical terms in this section]
    E.2.2Secondary objectives of the trial
    This study will provide data that will help us design a subsequent definitive trial, assuming the results of treatment are positive. It will also tell us which combination of treatments works best, so that the most appropriate treatment is selected for further study.

    We will also look at which clinical outcomes are best to measure, including a range of vision tests, and physical measurements of the size of the blood clot and scarring inside the eye (using photographs of the macula).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults of either sex aged 50 years and older;
    - SMH associated with treatment naive or previously treated wet AMD;
    - SMH involving the fovea and of sufficient density to obscure RPE detail.
    - Able to give informed consent
    E.4Principal exclusion criteria
    - SMH that is known to have been present for greater than 2 weeks duration, as evidenced by history, pre-trial documentation, or fundus appearance;
    - Presence of significant vitreous haemorrhage precluding accurate retinal assessment in the study eye;
    - Diabetic maculopathy in the study eye;
    - Visually significant cataract in the study eye;
    - Amblyopia in the study eye;
    - Presence of other ocular disease causing concurrent vision loss in the study eye;
    - Advanced glaucoma in the study eye (cup-to-disc ratio greater than 0.8);
    - Pregnant and or lactating women;
    - Women of childbearing potential including those who are not sterilised or at least one year post menopausal;
    - Participation in a clinical trial in the preceding 6 months;
    - Documented evidence of a visual acuity less than 25 ETDRS letters at three consecutive visits in the study eye, prior to the onset of submacular haemorrhage;
    - Participants who are known to have been ineligible for NICE approved ranibizumab therapy prior to the development of the SMH;
    - Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab, bevacizumab or aflibercept;
    - Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements.
    - Unable to give informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Mean ETDRS visual acuity at 3 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    E.5.2Secondary end point(s)
    - Mean ETDRS visual acuity at months 1 and 12
    - Percentage of eyes with 15 letters or greater improvement in ETDRS distance
    visual acuity at month 12
    - Percentage of eyes with 0 letters or greater improvement in ETDRS distance
    visual acuity at month 12
    - Percentage of eyes with 15 letters or greater loss in ETDRS distance visual
    acuity at month 12
    - Mean total area of macular haemorrhage on colour fundus photography at
    months 1, 3 and 6
    - Greatest linear dimension of macular haemorrhage on colour fundus
    photography at month 1, 3 and 6
    - Presence of subfoveal blood on colour fundus photography at month 1
    - Mean central retinal thickness on optical coherence tomography at months 1 and 12
    - Mean area of fibrosis on fluorescein angiography at month 12
    - Greatest linear dimension of fibrosis on fluorescein angiography at month 12
    - LOCSII cataract score at month 12
    - Mean Pelli-Robson contrast sensitivity at months 1, 6 and 12
    - Mean change in National Eye Institute Visual Function Questionnaire (VFQ25) at months 1, 3, 6 and 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Intravitreal 0.3 mLs 100% perfluoropropane gas
    E.8.2.4Number of treatment arms in the trial4
    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 No
    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 years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state55
    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)
    Once the patient has reached the end of the trial, and if they develop another bleed, then the treating ophthalmologist may repeat intervention, if deemed appropriate, and subject to local funding arrangements (most likely an individual funding authorization to the PCT or equivalent).
    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 Decision2013-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-15
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    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
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