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    Summary
    EudraCT Number:2010-021722-35
    Sponsor's Protocol Code Number:HYKP1015
    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:2010-08-18
    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 number2010-021722-35
    A.3Full title of the trial
    Diabetic macula oedema: A prospective randomised study comparing the detailed functional and anatomical changes of repeated pan anti-VEGF therapy with ranibizumab versus conventional macular laser therapy.
    A.3.2Name or abbreviated title of the trial where available
    Diabetic macular oedema & ranibizumab; detailed functional analysis
    A.4.1Sponsor's protocol code numberHYKP1015
    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 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 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 Yes
    D.2.1.1.1Trade name Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 nameLucentis
    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 INNRanibizumab
    D.3.9.1CAS number SO1LA04
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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
    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
    Diabetic macular oedema
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic Macular Oedema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of repeated injections of ranibizumab with laser treatment (existing treatment) on the detailed structure and function of the retina in subjects with diabetic macular oedema.
    E.2.2Secondary objectives of the trial
    As a secondary objective, the trial will also look at whether there is a difference in vision between the group treated with repeated ranibizumab injections and the group receiving laser treatment after one year. The trial will also measure the thickness of the macular, the central part of the retina, which is a useful measurement of the amount of oedema (leakage) present, to see whether there is a difference between the two groups, again after one year.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of either sex aged 18 years or over.
    2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
    i. Current regular use of insulin for the treatment of diabetes
    ii. Current regular use of oral anti-hyperglycaemic agents for the treatment of
    diabetes
    iii. Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for
    Diagnosis of Diabetes)
    3. Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9) within 14 days of randomisation.
    4. On clinical exam, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns within 14 days of randomisation.
    5. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
    6. Intraocular pressure less than 30 mmHg.
    7. Ability to return for study visits.
    8. Visual acuity in fellow eye ≥ 2/60.
    9. Fellow eye has no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months.
    10. Ability to give informed consent throughout the duration of the study.
    E.4Principal exclusion criteria
    1. Macular ischaemia (FAZ > 1000m in diameter or severe perifoveal intercapillary loss on IVFA).
    2. Macular oedema is considered to be due to a cause other than diabetic macular oedema.
    An eye should not be considered eligible if: (1) the macular oedema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular oedema.
    3. Co-existent ocular disease.
    4. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular oedema (e.g. foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal conditions, such as amblyopia).
    5. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
    6. A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).
    7. History of treatment for DMO at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
    8. History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation.
    9. Anticipated need for PRP in the 6 months following randomisation.
    10. Proliferative diabetic retinopathy in the study eye.
    11. A condition that, in the opinion of the investigator, would preclude participation in the study.
    12. Haemoglobin A1c > 11.0 mmol
    13. A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
    14. Blood pressure >170/100 (i.e. systolic above 170 or diastolic above 110). If blood pressure is brought below 170/100 by anti-hypertensive treatment, subject can become eligible.
    15. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation.
    16. Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
    17. Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study.
    18. Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation.
    19. Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation.
    20. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomisation.
    21. Aphakia.
    22. Uncontrolled glaucoma (in investigator’s judgment).
    23. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or severe blepharitis. If treated these patients can be included.
    24. Known allergy to fluorescein dye or to any component of the study drug.
    E.5 End points
    E.5.1Primary end point(s)
    The following outcomes will be compared between the 2 groups at baseline, 12, 24 and 48 weeks and comprise the primary outcome measures:

    A. Functional changes:
    i. Colour contrast sensitivity.
    ii. Microperimetry: mean retinal sensitivity & central 2.5 degree changes.
    iii. PERG. P50 amplitude and implicit time delay.
    iv. Full field ERG: a and b wave amplitudes and implicit times.
    vi. Multifocal ERG. The distribution of N1 and P1 wave amplitudes and implicit times.

    B. Anatomical changes:
    vii. Spectralis Optical Coherence Tomography. Central retinal thickness, macular volume and PRC layer thickness at the fovea and eccentric locations.
    viii. FAZ greatest linear diameter, area and degree of perifoveal capillary dropout.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Macular laser photocoagulation
    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.8.5.1Number of sites anticipated in the EEA0
    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 final visit of the last subject.
    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 months3
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days27
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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)
    It is anticipated that ranibizumab will be licensed by the EMEA in July 2011 for use in DMO. Post-completion of the trial it is our intention to request that for all patients who have participated in the study, the patients' Primary Care Trusts continue therapy on compassionate grounds.
    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 Decision2010-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-16
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