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    Summary
    EudraCT Number:2007-003853-97
    Sponsor's Protocol Code Number:PNB1
    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:2007-10-15
    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 number2007-003853-97
    A.3Full title of the trial
    A 23-month randomised, masked, prospective phase IV study assessing the safety and efficacy of two alternative treatment regimes using Bevacizumab (AvastinTM) to treat patients with subfoveal and juxtafoveal choroidal neovascularisation caused by age-related macular degeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Greater Manchester Avastin for Choroidal Neovascularisation (GMAN) Trial
    A.3.2Name or abbreviated title of the trial where available
    GMAN Trial
    A.4.1Sponsor's protocol code numberPNB1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN34221234
    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 SponsorCentral Manchester University Hospitals 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 supportLead Commissioner - Greater Manchester Primary Care Trusts
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentral Manchester University Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointResearch Office
    B.5.3 Address:
    B.5.3.1Street AddressOxford Road
    B.5.3.2Town/ cityManchester
    B.5.3.3Post codeM13 9WL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044161276 3565
    B.5.5Fax number0044161276 5766
    B.5.6E-mailresearch.secretary@cmft.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 Avastin 25mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) Yes
    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
    "wet" or "exudative" age-related macular degeneration (AMD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10015902
    E.1.2Term Exudative senile macular degeneration of retina
    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 demonstrate that a treatment regime over 11 and 24 months where Bevacizumab is given monthly for three months and then on a prn basis at three monthly intervals, the “PRN” treatment arm, is not inferior to a regime where Bevacizumab is given monthly for three months and then every three months irrespective of clinical symptoms and signs, the “ROUTINE” treatment arm, with respect to Best-Corrected Visual Acuity (BCVA) on a LogMAR scale.

    • To evaluate the safety of intravitreal Bevacizumab as assessed by ophthalmic and vital signs evaluations and adverse events reports over 24 months.

    E.2.2Secondary objectives of the trial
    • Investigation of equivalence between two arms using additional measures of visual function

    • To evaluate the efficacy of the two Bevacizumab treatment regimes by changes in visual function

    • To determine the mean number of treatments required

    • To investigate the correlation between BCVA and additional measures of visual function

    • To evaluate the efficacy of the two Bevacizumab treatment regimes by measuring changes from baseline of optical coherence tomography and fluorescein angiographic parameters

    • To explore the temporal changes in BCVA at months 1, 2 and 3 to evaluate the onset of treatment effect.

    • To undertake pharmacogenetic studies to determine whether any variations in treatment response can be attributed to identifiable genetic variations (this component has a separate information sheet and consent form – see section 20)


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men or women of any ethnic background over the age of 50 years with AMD

    • Subfoveal choroidal neovascularisation or juxtafoveal choroidal neovascularisation where laser would ablate the centre of the FAZ

    • Predominantly-classic CNV

    • Minimally classic or occult with no classic CNV lesion composition where there is evidence of recent disease progression (i.e. vision loss, lesion growth on FFA, progression on OCT examination, new blood associated with lesion within the preceding three months)

    • The total area of CNV within the lesion (including classic and occult components) must be greater than 50% of the lesion area as defined by FFA

    • The BCVA letter score must be between logMAR 0.3 – 1.2 (approximately 6/12 to 6/96 Snellen equivalent)

    • Patients must have completed study consent forms and must be willing and able to comply with all of the study protocols

    E.4Principal exclusion criteria
    • Prior treatment to the CNV lesion

    • Lesion components including fibrosis, haemorrhage or pigment epithelial detachment representing greater than 50% of the lesion

    • Retinal pigment epithelial tear (rip)

    • Active intraocular inflammation within one month of screening for study

    • Uncontrolled glaucoma in study eye (IOP of greater than 25 mmHg despite anti-glaucomatous medication)

    • History of ocular surgery or YAG (yttrium aluminium garnet) laser capsulotomy within two months of screening for study

    • History of allergy to fluorescein

    • Any systemic medication that may interfere with the safety of the patient or is known to be toxic to the retina

    • Uncontrolled hypertension

    • Within one month of major surgery

    • History of myocardial infarction, stroke or gastrointestinal perforation.

    • Episode of angina or transient ischaemic attack within 6 months of screening

    • Pregnancy or breast feeding women

    • Women of child-bearing potential unless they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH levels > 40mIU/ml or six weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception (implantable, patch, oral), and double barrier method (any combination of: intrauterine devise (IUD), male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout thee study and for 30 days after study drug discontinuation.

    E.5 End points
    E.5.1Primary end point(s)
    Visual acuity at 24 months in each arm of the 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 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 Yes
    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 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
    Comparison of two treatment regimes with same drug
    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.8.5The 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 Information not present in EudraCT
    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
    The end point of the trial is when all patients enrolled into the trial have been followed up for 24 months unless they decide to leave the study prematurely.
    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 months6
    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 months6
    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 No
    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 state330
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    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 Decision2007-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-31
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