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    Summary
    EudraCT Number:2015-002302-36
    Sponsor's Protocol Code Number:MATE2015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-07-08
    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 number2015-002302-36
    A.3Full title of the trial
    Treating neovascular age-related Macular Degeneration with Aflibercept:A multi-centre randomized controlled trial comparing Standard Care with an individualised Treat and Extend regimen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The MATE study
    A.3.2Name or abbreviated title of the trial where available
    The MATE study
    A.4.1Sponsor's protocol code numberMATE2015
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN58955026
    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 SponsorYork Teaching Hospital
    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 supportBayer Healthcare UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationYork Teaching Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointDeborah Phillips
    B.5.3 Address:
    B.5.3.1Street AddressWigginton Road
    B.5.3.2Town/ cityYork
    B.5.3.3Post codeYO31 8HE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01904725123
    B.5.6E-maildeborah.phillips@york.nhs.uk
    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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharm AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameAflibercept
    D.3.4Pharmaceutical form Solution for injection
    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 INNAflibercept
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neovascular Age-related macular degeneration
    E.1.1.1Medical condition in easily understood language
    wet AMD
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Outcome 1. The main objective of the study is to determined if a multicentered phase 3 randomised control trial comparing two treatment regimens of Aflibercept for neovascular age related macular degeneration be safely and effectively conducted and delivered.

    Outcome 2. Long term (4 years)changes in visual acuity and the central thickness of the retina. Also focussing on the number of injections and visits in each group
    E.2.2Secondary objectives of the trial
    The secondary outcomes will look into the changes in visual acuity and the central thickness of the retina. Also focussing on the number of injections and visits in each group. This study will inform the conducting of a larger phase 3 randomised control trial

    Exploratory. Addition of a monitor and extend phase in the third and fourth years and imagining biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Visual impairment predominantly due to neovascular Age –related Macular Degeneration (AMD).
    •Active, treatment naive , angiographically active choroidal neovascular membrane in the study eye secondary to neovascular AMD with any part of the lesion or its sequelae (e.g. sub retinal fluid, intra retinal fluid, haemorrhage, pigment epithelial detachment, sub retinal pigment epithelium(RPE) fluid) in a sub foveal location.
    •Visual acuity of 78-24 ETDRS letters at screening and baseline in the study eye.
    •Age >/= 50 years.
    •Able to provide written, informed consent to the study.
    •Able and willing to attend for hospital visits at the frequency required.
    •If both eyes are eligible at baseline, the worst seeing eye will be included in the study although the final decision will rest with the investigator. Any deviation from entering the worst seeing eye into the study will be explained and documented in the patient notes and the CRF. The choice of eye selected for inclusion into the study will be determined and documented before the patient is randomised. A patient who has both eyes that may be eligible may therefore undergo a different treatment regimen in each eye, however they will be treated with aflibercept in both eyes. Hospital visits will be co-ordinated to minimise the number of attendances required and therefore the inconvenience for the patient.
    E.4Principal exclusion criteria
    •Inability to comply with the study or follow up procedures.
    •Pregnant or lactating women.
    •Women of child bearing potential unless they are using effective methods of contraception (total abstinence, female or male sterilization, barrier contraception, intrauterine device, oral or injectable hormonal methods of contraception).
    •Previous treatment for choroidal neovascularisation in the study eye.
    •Fibrosis consisting of more than 50% of the lesion or involving the centre of the fovea.
    •Co-existing pathology within 0.5 disc diameters of the fovea that could prevent an improvement in visual acuity in the opinion of the investigator (e.g. macular hole, dense epi - retinal membrane)
    •Cataract (causing significant visual impairment), aphakia, vitreous haemorrhage, retinal detachment, proliferative retinopathy or CNV due to any cause other than AMD at screening and baseline.
    •Known allergy to aflibercept or fluorescein.
    •History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the screening visit.
    •Any type of systemic disease or treatment that may affect or expect to affect the clinical status of the patient to a significant degree.
    •Blood pressure of >160mmHg systolic or >100mmHg diastolic at screening or baseline.
    •Any active periocular infection or inflammation at screening or baseline.
    •Uncontrolled glaucoma (30mmHg) at screening or baseline.
    •Neovascularisation of the iris at screening or baseline.
    •Treatment with any anti angiogenic drugs to either eye within 3 months of baseline.
    •Nd-YAG laser capsulotomy within the last 2 months or expected within 6 months of baseline in the affected eye.
    •Use of other investigational drugs within 30 days.
    •Use of systemic anti – vascular endothelial growth factor agents within 3 months prior to baseline.
    •Use of systemic corticosteroids for at least 30 consecutive days within the 3 months prior to baseline.
    •Current or planned medications known to be toxic to the lens, retina or optic nerve e.g. hydroxychloroquine, desferoxamine, tamoxifen or ethambutol.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate if a randomised controlled trial comparing treat and extend regimen with standard of care with Aflibercept for neovascular age–related macular degeneration can be performed effectively and inform a main study.

    The outcome will be part quantitative and part qualitative with predefined criteria of success based around the following topics:
    •Process: e.g. recruitment rates, retention rates.
    •Resources: e.g. budget, timescale of protocol, length of time to fill out study forms.
    •Management: e.g. data management issues, problems faced by site personnel.
    •Scientific content: e.g. treatment safety
    Key outcomes to meet success of the Pilot:
    •1) Recruitment of 80% of patients within the recruitment window
    •2) 20 % or less withdrawal rate from the study at 2 years

    The above mentioned feasibility aspects will be assessed throughout the study. Individual site personnel and various other members involved in the running of the study will maintain a record of these feasibility aspects, which will be collected and assessed at the end of recruitment or study as appropriate. This will help in the design and running of a future main study.

    Outcome 2.

    To evaluate the long term outcomes of the initial treatment regimens and their burden on patients and services at 36 and 48 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome 1 analysis is qualitative in nature, data will be collected mainly post recruitment and End of trial, with the main analysis being done at the end of the study.

    Primary Outcome 2 will be analysed at the end of the study - 48 months.
    E.5.2Secondary end point(s)
    To evaluate the efficacy of the treatment regimens and their burden on patients and services by assessing:
    •Mean change in ETDRS visual acuity at 12 and 24 months between the two arms.
    •Percentage of patients gaining and losing more than or equal to 15 ETDRS letters at 12 and 24 months.
    •Mean change in central retinal thickness compared with baseline at 12 months and 24 months between the two arms.
    •Mean number of treatments in the study eye at 12 and 24 months.
    •Mean number of visits for the study eye at 12 and 24 months.
    •Mean change in Mac DQoL, MacTSQ at 12 and 24 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis of data with particular attention to safety at completion of 12 month follow up of the last patient and data analysis at 24 and 48 months.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Pilot study
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Comparing individualised treat and extend regimen with Standard Care of Aflibercept for nvAMD.
    E.8.2.4Number of treatment arms in the trial2
    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 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 Yes
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    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)
    On completetion of the study, further follow up and care will be arranged in the local NHS Ophthalmology clinics. Arrangements will be made by the research team for the participants to receive the respective NHS Trust's Standard of care for neovascular age -related macular degeneration at that time.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-20
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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