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    Summary
    EudraCT Number:2011-001869-41
    Sponsor's Protocol Code Number:OKHN1005
    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:2011-07-14
    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 number2011-001869-41
    A.3Full title of the trial
    An exploratory study of ranibizumab (Lucentis) for treatment of uveitic patients with refractory cystoid macular oedema. 'The LIMO study'
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ranibizumab (Lucentis) for treatment of Uveitic Macular Oedema (LIMO)
    A.3.2Name or abbreviated title of the trial where available
    Ranibizumab (Lucentis) for treatment of Uveitic Macular Oedema (LIMO)
    A.4.1Sponsor's protocol code numberOKHN1005
    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 supportNovartis Pharmaceuticals UK Ltd
    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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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 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 INNRanibizumab
    D.3.9.1CAS number SO1LA04
    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 number10
    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.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Uveitic Macular Oedema
    E.1.1.1Medical condition in easily understood language
    Uveitic macular oedema is a condition that affects the eyesight by causing fluid to accumulate witin the central part of the eye's retina.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10058202
    E.1.2Term Cystoid macular oedema
    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
    Does ranibizumab improve visual outcome in patients with uveitic macular oedema refractory or ineligible for 'standard of care' therapy?
    E.2.2Secondary objectives of the trial
    Is intravitreal ranibizumab safe, efficacious and acceptable therapy in patients with uveitic macular oedema refractory or ineligible for 'standard of care' therapy?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria
    1. Age >= 18 years and less than 75 years
    2. Diagnosis of uveitis of non-infectious origin
    3. Able and willing to provide informed consent
    4. Able and willing to attend for follow-up on Clinical Trial Unit, as per SOA


    Study Eye Inclusion Criteria
    The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.
    1. Cystoid macular oedema (CMO) from non-infectious uveitis:
    a. Unilateral or Bilateral CMO (the worse eye only will be treated with intravitreal Ranibizumab) in a quiet eye for ≥ 1month
    b. On clinical exam and OCT, definite retinal thickening due to uveitic macular oedema involving the centre of the macula, refractory or ineligible for ‘standard care’
    c. Spectralis SD-OCT central subfield >=270 µm within 10 working days of study entry with uveitic macular oedema (cystoid or diffuse)
    d. Quiet eye
    i. as defined by 0-0.5 plus of cells in anterior chamber of the eye, and 0.5 or less vitreous haze (SUN classification)
    ii. topical / systemic immunosuppressive treatment allowed but stable for 2 month with no resolution of CMO in a quiet eye for ≥1 month
    iii. greater than 3 months since orbital steroid injection, 4 months since intravitreal triamcinolone treatment, or 8 weeks since starting new oral therapy
    iv. at least 1 prior trial of oral, orbital or intravitreal steroid therapy for CMO or not eligible for steroid treatment (oral, orbital or intravitreal steroid) because IOP > 30 mmHg following such use in study eye or fellow eye (i.e. patient is a known steroid responder), at any time in the past

    2. Best corrected visual acuity in the study eye must be between 69 and 35 ETDRS letter score at 4m (Snellen equivalent of 6/12-6/60) within 10 working days of enrolment.
    E.4Principal exclusion criteria
    General Exclusion Criteria
    1. Unstable cardiovascular disease or significant renal disease (defined as a history of chronic renal failure requiring dialysis or kidney transplant).
    2. Known allergy to any component of the study drug.
    3. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). Patients with controlled systemic hypertension will be included. In all patients BP will be monitored and the primary care physician notified should systolic >150 and diastolic >90.
    4. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischaemic attack, or treatment for acute congestive heart failure or gastrointestinal ulceration or haemorrhage within 6 months prior to study entry.
    5. Active ischaemia on ECG
    6. Any anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
    7. Pregnancy or lactating or intending to become pregnant within the next 12 months.


    Study Eye Exclusion Criteria
    1. Insufficient patient cooperation or media clarity to allow adequate fundus imaging.
    2. Other causes of macular oedema e.g. diabetic macular oedema, juxtafoveal telangectasia etc
    3. 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)
    4. Evidence of irreversible central visual loss
    a. marked areas of decreased autofluorescence consistent with retinal atrophy, which would indicate that any improvement in visual acuity would be highly unlikely
    b. central macular scarring
    5. Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT
    6. 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 cataract surgery within prior 6 months or cataract surgery anticipated within 6 months of starting the trial
    8. History of vitrectomy
    9. Any anti-VEGF treatment to study eye within 4 months.
    10. History of YAG capsulotomy performed within 2 months prior to randomization.
    11. Aphakia.
    12. Uncontrolled IOP > = 24 mmHg (on topical IOP lowering medications)
    13. History of glaucoma.
    14. A history of inherited retinal degeneration
    E.5 End points
    E.5.1Primary end point(s)
    1. The number of patients in whom, by consensus, no further treatment is required
    2. Change in central retinal thickness as measured by spectral domain OCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six and twelve months
    E.5.2Secondary end point(s)
    Efficacy:
    - functional vision changes based on self-reported QoL measures
    - proportion of subjects gaining >10 and >15 letters
    - change in contrast sensitivity
    - change in BCVA
    - proportion of subjects with loss of >15 and >30 letters
    - change in retinal sensitivity on microperimetry
    - change in reading speed
    - evidence of improvement in PERG or mfERG

    Safety:
    - maintenance of foveal avascular zone
    - absence of toxicity on electrophysiological testing/microperimetry/autofluorescence
    - incidence and severity of ocular and non-ocular adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Six and twelve 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number 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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Ranibizumab, 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 Decision2011-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-18
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