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    Summary
    EudraCT Number:2014-002381-73
    Sponsor's Protocol Code Number:PATP1023
    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:2014-09-01
    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 number2014-002381-73
    A.3Full title of the trial
    Individualizing therapy for neovascular age-related macular degeneration with aflibercept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Individualising treatment for wet age-related
    macular degeneration -The VITAL Study
    A.3.2Name or abbreviated title of the trial where available
    VITAL
    A.4.1Sponsor's protocol code numberPATP1023
    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 SponsorMoorfields Eye 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMoorfields Eye Hospital
    B.5.2Functional name of contact pointNatasha Ajraam
    B.5.3 Address:
    B.5.3.1Street AddressCity Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1V 2PD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02072533411
    B.5.5Fax number02076086925
    B.5.6E-mailnatasha.ajraam@moorfields.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 Aflibercept
    D.2.1.1.2Name of the Marketing Authorisation holderBayer pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.2Product code Not applicable
    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.3.9.1CAS number 862111-32-8
    D.3.9.3Other descriptive nameEylea
    D.3.9.4EV Substance CodeAS2
    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 Yes
    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 No
    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 age-related macular degeneration (wet AMD)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    Our primary aim is to estimate the average change in vision function in eyes treated with aflibercept.
    E.2.2Secondary objectives of the trial
    Our secondary objective is to report the number of hospital visits needed over two years to achieve our primary objective.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Newly diagnosed, angiographically documented, previously untreated, active CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.

    Best corrected visual acuity score in the study eye of between 80 and 23 letters inclusive, using ETDRS testing, (between 6/7.5 and 6/96 Snellen equivalent), inclusive.

    The CNV or sequela of the CNV (i.e., pigment epithelium detachment, subretinal haemorrhage, blocked fluorescence, macular edema, or subretinal or intraretinal fluid) must involve the centre of the fovea.

    The total area of fibrosis must comprise less than 50% of the total lesion.

    > 1 drusen (>63 microns) in either eye OR late AMD in fellow eye.

    No previous treatment for CNV in the study eye.

    Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging.

    Signed informed consent form

    Age ≥ 50 years of either gender

    Women must be postmenopausal for at least 12 months prior to trial entry, or surgically sterile. If of child bearing potential, a serum pregnancy test with a negative result must be obtained within 14 days prior to the first treatment.

    Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 60 days following the last dose of study medication.

    No condition that precludes follow-up for 2 years.

    No contraindication to intravitreous injection of aflibercept
    E.4Principal exclusion criteria
    Any previous treatments for wet AMD (including verteporfin PDT, Macugen®, Lucentis®, intravitreous Avastin®, thermal laser, external beam radiation or surgery for AMD) in the study eye

    Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil®), phenothiazines and ethambutol.

    Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment

    Concurrent or previous use of systemic anti-VEGF agents.
    Any intraocular procedure (including Yttrium-Aluminium-Garnet capsulotomy) within 2 months prior to Screening or anticipated within the next 6 months following Screening
    Permanent structural damage (fibrosis or atrophy) involving the centre of the fovea in the study eye

    CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia

    Retinal pigment epithelial tear involving the fovea in the study eye

    Any concurrent intraocular condition in either eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 2 year follow-up period to prevent or treat visual loss that might result from that condition, or, if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 2 year follow-up period.

    Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in either eye

    Neovascularisation of the iris, neovascular glaucoma or vitreous haemorrhage in either eye at the screening visit

    History of rhegmatogenous retinal detachment, epiretinal membrane, vitreomacular traction or macular hole in the study eye if in the investigators opinion, thought to limit potential for vision improvement after treatment for wet AMD

    History of vitrectomy in study eye

    Active infectious conjunctivitis, blepharitis, keratitis, scleritis, or endophthalmitis in either eye at the time of screening

    Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia

    For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.

    Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding the first study treatment.

    Uncontrolled glaucoma in either eye at the time of screening (defined as intraocular pressure >25 mmHg despite treatment with anti-glaucoma medication)

    Inability to be photographed or to document CNV (eg due to allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV).

    Inability to obtain OCT images of reasonable quality to allow analysis of lesion or macular fluid

    Other ocular diseases or conditions that can compromise the visual acuity of the study eye such as amblyopia, anterior ischemic optic neuropathy, previous complicated cataract surgery, aphakia, vitreomacular traction or diabetic macular oedema

    Pregnancy or breastfeeding

    History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications

    Current treatment for active systemic infection
    Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
    History of recurrent significant infections or bacterial infections

    Inability to comply with study or follow-up procedures

    Stroke or myocardial infarction less than 3 months from Screening date

    Known hypersensitivity to aflibercept
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is as follows: Report the mean change in vision in eyes treated with intravitreous aflibercept using three, monthly doses followed by two monthly dosing in year one and a capped, treat-and-extend treatment paradigm in year two patients after 24 months in patients with wet AMD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Descriptive analysis will be used to explore the primary outcome data. The mean change in vision after 24 months will be presented with alongside the standard error and two-sided 95% confidence interval.
    E.5.2Secondary end point(s)
    Our secondary end point is to report the number of hospital visits needed over two years to achieve the results needed to obtain the answer to our primary outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over two years (end of study).
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state50
    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)
    If clinically indicated, participants will continue to be monitored and treated accordingly in the NHS outpatient clinic at our hospital. Their ongoing care will be monitored by the principal investigator or original referring consultant.
    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 Decision2014-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-26
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