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    Summary
    EudraCT Number:2011-003304-20
    Sponsor's Protocol Code Number:OKHN1006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-17
    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 number2011-003304-20
    A.3Full title of the trial
    Randomised Controlled Trial of Intravitreal therapy with Avastin compared to Observation in Patients with Diabetic Ischaemic Macular Oedema
    ‘The DIME study’
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison between injections into the eye ( drug Avastin) with 'pretend' injections in diabetic patients in whom no further treatment is currently available in clinic when they have developed swelling of the centre of the macular associated with lack of blood supply.
    A.3.2Name or abbreviated title of the trial where available
    RCT of Avastin in ischaemic diabetic macular oedema (DIME Study)v 1.8
    A.4.1Sponsor's protocol code numberOKHN1006
    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 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 supportFight for Sight
    B.4.2CountryUnited Kingdom
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 namebevacizumab
    D.3.4Pharmaceutical form Concentrate 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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    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 number25
    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 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
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntraocular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischaemic Diabetic Macular Oedema
    E.1.1.1Medical condition in easily understood language
    Swelling of the central part of the retina( the macula)which is receiving a poor blood supply.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012689
    E.1.2Term Diabetic retinopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012688
    E.1.2Term Diabetic retinal oedema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012661
    E.1.2Term Diabetic eye disease
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054372
    E.1.2Term Diabetic retinal edema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10038925
    E.1.2Term Retinopathy diabetic
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic macular oedema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10012657
    E.1.2Term Diabetic complications ophthalmic
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054109
    E.1.2Term Non-proliferative diabetic retinopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10012653
    E.1.2Term Diabetic complications
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is it possible to improve visual function, prove safety and acceptability of the use of Avastin eye injections in patients with diabetic ischaemic macular oedema?
    E.2.2Secondary objectives of the trial
    1. Does Avastin therapy improve functional vision (based on self-reported quality of life measures)?
    2. Are 6 weekly intravitreal injections acceptable (based on self-reported quality of life measures)?
    3. Does Avastin therapy improve visual acuity (gain of 15 letters or more), contrast sensitivity, and reading speed, and improve relative change in macular thickness (as measured by OCT scan).
    4. Is Avastin therapy in this group of patients safe? (Maintenance of foveal avascular zone, absence of toxicity on Electrophysiological tests / Humphrey 10-2 /autofluorescence/ GDx, maintenance of retinal sensitivity on microperimetry, maintenance of colour vision)
    5. Is Avastin therapy in this group of patients cost-effective? (Measurement of EQ-5D scores).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Assessment of central visual field changes in relation to macular disease remains difficult to correlate with current available technology. As part of the current project, we have the aim of developing new software for PROGRESSOR analysis which would analyse the Humphrey-10-2 (central) visual field data collected on patients with DIME, correlate with Microperimetry / Electrophysiology / clinical data, in order to establish usefulness of PROGRESSOR 10-2 for objective serial outcome measurements (of central macular function). We would then hope that this new software would be available to any eye department with a standard Humphrey perimeter.
    E.3Principal inclusion criteria
    General Inclusion Criteria
    • Age >= 18 years and less than 75 years
    • Diagnosis of diabetes mellitus (type 1 or type 2)
    • Able and willing to provide informed consent
    Study Eye Inclusion Criteria
    The subject must have one eye meeting ALL of the inclusion criteria and NONE of the exclusion criteria listed below.
    • Best corrected ETDRS visual acuity LogMAR (and approximate Snellen equivalent), between 0.47-1.30, 10 working days of randomization. (Equivalent to 6/18 – 3/60)
    • On clinical exam, definite retinal thickening due to diabetic macular oedema involving the centre of the macula.
    • OCT central subfield >=250 µm within 10 working days of randomization.
    • In the opinion of the examining ophthalmologist laser treatment is ineffective or contraindicated because of the state of the Foveal avascular zone (reflecting at least moderate macular ischaemia) on fluorescein angiography. At the point when the ophthalmologist enters into the hospital medical notes that ths individual is not to have further laser treatment, the patient may be considered for inclusion into this study.
    • Patients with an enlarged foveal avascular zone (FAZ) of diameter ≥1000 µm or a non-intact perifoveal capillary ring at the margin of the FAZ with FAZ 700-1000 µm in the transit phase of FFA will be defined as having macular ischaemia.
    E.4Principal exclusion criteria
    General Exclusion Criteria
    • Unstable cardiovascular disease or significant renal disease, (defined as a history of chronic renal failure requiring dialysis or kidney transplant).
    • Known allergy to any component of any study drug.
    • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
    • Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
    • Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
    • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
    • Any anti-VEGF treatment to either eye at any time.

    Study Eye Exclusion Criteria
    • Insufficient patient cooperation to allow adequate fundus photographs.
    • Other causes of macular oedema
    • Presence of an ocular disease that in the opinion of the investigator, is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates.)
    • 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 20/40 or worse if eye was otherwise normal).
    • History of major ocular surgery (including vitrectomy, cataract extraction) within prior 4 months.
    • Insufficient Media clarity to allow adequate fundus photographs.
    • History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
    • History of panretinal photocoagulation (PRP) within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
    • History of YAG capsulotomy performed within 2 months prior to randomization.
    • Aphakia.
    • Intraocular pressure >= 25 mmHg.
    E.5 End points
    E.5.1Primary end point(s)
    Stabilization of visual acuity (loss of less than 10 letters)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each subject will be followed up for 12 months. This end point will be evaluated at 12 months
    E.5.2Secondary end point(s)
    1. Functional vision changes based on self reported quality of life measures.
    2. Acceptability of 6 weekly intravitreal therapy.
    3. Improvement of visual acuity (gain of 15 letters or more), contrast sensitvity and reading speed.
    4. Relative change in macular thickness as measured by OCT scan.
    5. Maintenance of foveal avascular zone, absence of toxicity on electrophysiology tests, autofluorecence, GDx, maintenance of retinal sensitivity on micoperimetry, maintenance of colour vision.
    6. Cost-effectiveness: measurement of EQ-5D scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each subject will be followed up for 12 months. These secondary end points will be evaluated at 12 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 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) Yes
    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 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
    Sham injections
    E.8.2.4Number of treatment arms in the trial1
    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 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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state84
    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)
    The patients are to be recruited from our Outpatients department. Once the study is finished they will be returned to the Outpatients clinics, where the most appropriate treatment will be offered to them. If this study proves that the most appropriate treatment is intravitreal bevacizumab, then applications to their Primary Care Trusts for funding of treatment will be made, citing evidence from this study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-10-15
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