Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-015559-25
    Sponsor's Protocol Code Number:KCH1724
    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:2010-03-29
    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 number2009-015559-25
    A.3Full title of the trial
    Preoperative intravitreal ranibizumab for persistent diabetic vitreous haemorrhage: A randomized, double-masked, controlled study
    A.3.2Name or abbreviated title of the trial where available
    Vitreous Haemorrhage Study
    A.4.1Sponsor's protocol code numberKCH1724
    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 SponsorKing's College 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 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 10mg/ml solution for injection
    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 10mg/ml solution for intravitreal injection
    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 347396-82-1
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubconjunctival use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Retinopathy is a well recognised complication of diabetes and is a leading cause of vision loss in this patient group. The severity of diabetic retinopathy varies, but in its most severe form (proliferative diabetic retinopathy or PDR), ocular ischaemia causes abnormal new blood vessels to grow in the retina. These fragile new vessels may bleed into the vitreous cavity. The resulting vitreous haemorrhage impairs vision and prevents further therapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.
    E.1.2Level LLT
    E.1.2Classification code 10047655
    E.1.2Term Vitreous Haemorrhage
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if a single preoperative eye injection of ranibizumab (Lucentis) can promote clearance of persistent haemorrhage in the inner cavity of the eye, and thereby avoid pars plana vitrectomy (eye surgery to remove the blood inside the eye).
    E.2.2Secondary objectives of the trial
    Secondary outcome measures:
    1.Number of patients requiring eye surgery (pars plana vitrectomy) at study end
    2.Mean duration from baseline to eye surgery (primary pars plana vitrectomy)
    3.Number of intraocular procedures required
    4.Mean ETDRS visual acuity*
    5.Mean grade of vitreous haemorrhage (Grade 0-4)** at 6 weeks after the ramibizumab (Lucentis) or Sham injection
    6.Surgical complications
    7.Grading of the patient's lens clarity using LOCS II***

    * ETDRS is an eyechart that scores the number of letters the patient reads correctly
    ** The grading system for vitreous haemorrhages is a well recognised grading scale ranging from mild haemorrhage to severe haemorrhage (0 to 4).
    *** The eye has a lens similar to the lens in a camera. Surgery to remove diabetic vitreous haemorrhage can produce lens opacity (cataract) that impairs the vision. The lens opacities classification system version II (LOCS II) describes the degree of lens opacity, and is assessed using slit-lamp examinat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria

    1. Adults (male or female over 18) with Type 1 or Type 2 diabetes mellitus
    2. Grade 2-4 fundus obscuring diabetic vitreous haemorrhage of at least 2 months duration prior to screening in the study eye
    3. Subjects who have elected to undergo a therapeutic pars plana vitrectomy to clear persistent diabetic vitreous haemorrhage
    4. Best corrected visual acuity from 40 letters (using 4 metre ETDRS visual acuity score) to perception of light in the study eye
    5. Patients able and willing to give written and witnessed informed consent.
    E.4Principal exclusion criteria
    Exclusion criteria

    1. The presence of tractional retinal elevation in the study eye, as detected by B mode ocular ultrasound or fundus biomicroscopy.
    2. Other (non-diabetic) cause of vitreous haemorrhage
    3. Other (non-diabetic) retinal vasculopathy in the study eye
    4. Subjects who were listed for vitrectomy for recurrent vitreous haemorrhage alone, and not for persistent vitreous haemorrhage
    5. Subjects whose planned vitrectomy was to have been combined with cataract surgery
    6. Prior vitrectomy in the study eye
    7. Visual acuity worse than 6/96 in the non study eye
    8. Aphakia in the study eye
    9. Pregnant (urine dipstick confirmed) or lactating women(women of childbearing potential should be advised to use appropriate contraception for three months following eye injection).
    10. Those with systemic or ocular contraindications to ranibizumab therapy
    11. Sickle cell disease. Those with sickle trait may be included if there is no evidence of retinopathy in the non study eye.
    12. Patients who have had an intravitreal injection of any therapeutic agent in the study eye
    13. Subjects with active concomitant disease in the study eye, including uveitis and infection
    14. Subjects with inadequate pupil dilation in the study eye, or other cause of significantly impaired fundus view
    15. Subjects with potentially visually significant cataract in the study eye
    16. Subjects who have undergone intraocular surgery in the study eye at least 6 months prior to screening, with the exception of cataract surgery, which must have been at least 2 months prior to screening.
    17. Subjects who have commenced medications that target haemostasis within 3 months of screening, including antithrombotic, antiplatelet and anticoagulant therapy, or who are likely to commence or alter such medications during the course of the study. Subjects who have commenced treatment with these agents at least 3 months prior to screening, and who are stable on treatment, are eligible for inclusion.
    18. Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year
    19. Patients unable or unwilling to give informed consent
    20. Patients unable or unwilling to return for follow up over 12 months
    21. Any other condition or situation that, in the opinion of the investigator, may prevent the patient from complying with the study protocol
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of patients requiring pars plana vitrectomy at week 7
    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 No
    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 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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 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
    The end of trial will be once all the participants have been reviewed at the end of their 12 months involvement.
    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 months0
    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 months0
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 24
    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 intervention is a one off treatment with an intravitreal injection to the eye with the persistent diabetic vitreous haemorrhage. Management after the completion of the trial will be as clinically indicted with current standard therapies.
    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 Decision2010-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-20
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 11:57:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA