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    Clinical Trial Results:
    The use of Ranibizumab (Lucentis ®) for the treatment of corneal neovascularisation

    Summary
    EudraCT number
    		 2010-018673-37
    Trial protocol
    		 GB  
    Global end of trial date
    12 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Apr 2018
    First version publication date
    26 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    10011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    East atrium, Jubilee conference centre, Triumph road, Nottingham, United Kingdom, NG8 1DH
    Public contact
    Professor Harminder Dua, University of Nottingham, harminder.dua@nottingham.ac.uk
    Scientific contact
    Professor Harminder Dua, University of Nottingham, harminder.dua@nottingham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Feb 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the use of the drug in the treatment of active corneal new blood vessels.
    Protection of trial subjects
    Subconjunctival injections were administered under topical anaesthesia and topical antibiotics were given as standard.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All participants were recruited from the 15th of March 2011 till the 18th of February 2013. They were all recruited in the UK from the cornea clinics of Queens Medical Centre, Nottingham.

    Pre-assignment
    Screening details
    		 Inclusion criteria - Patients over the age of 18 - With corneal neovascularisation non responsive or non tolerant to conventional steroid therapy - And capable of consenting Exclusion criteria - Patients under 18 years of age - Patients unable to provide informed consent - Patients who are needle phobic - Patients refusing consent - Pregna

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Treatment group
    Arm description
    		 Patients will receive subconjunctival injections around the limbus in the quadrant(s) affected (total volume of no more than 0.2ml of the 10mg/ml solution). The Subconjuctival injections will be administered in the treatment room under topical anaesthetics adjacent to the new corneal vessels and topical antibiotic will be given as standard after subconjunctival injection. Patient will be seen and assessed after two weeks and a second injection may be given if no effect is seen at the end of the second week but no more than a total of 2 injections will be given (for macular degeneration up to 4 injections per year are administered)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    Other name
    Lucentis
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subconjunctival use
    Dosage and administration details
    Patients will receive subconjunctival injections around the limbus in the quadrant(s) affected (total volume of no more than 0.2ml of the 10mg/ml solution). The Subconjuctival injections will be administered in the treatment room under topical anaesthetics adjacent to the new corneal vessels and topical antibiotic will be given as standard after subconjunctival injection. Patient will be seen and assessed after two weeks and a second injection may be given if no effect is seen at the end of the second week but no more than a total of 2 injections will be given (for macular degeneration up to 4 injections per year are administered) Patients will be monitored fortnightly for the first month and then at months 2, 4 and 6.

    Number of subjects in period 1
    		Treatment group
    Started
    6
    Completed
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 Patients will receive subconjunctival injections around the limbus in the quadrant(s) affected (total volume of no more than 0.2ml of the 10mg/ml solution). The Subconjuctival injections will be administered in the treatment room under topical anaesthetics adjacent to the new corneal vessels and topical antibiotic will be given as standard after subconjunctival injection. Patient will be seen and assessed after two weeks and a second injection may be given if no effect is seen at the end of the second week but no more than a total of 2 injections will be given (for macular degeneration up to 4 injections per year are administered)

    Reporting group values
    		 Treatment group Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adult
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 Patients will receive subconjunctival injections around the limbus in the quadrant(s) affected (total volume of no more than 0.2ml of the 10mg/ml solution). The Subconjuctival injections will be administered in the treatment room under topical anaesthetics adjacent to the new corneal vessels and topical antibiotic will be given as standard after subconjunctival injection. Patient will be seen and assessed after two weeks and a second injection may be given if no effect is seen at the end of the second week but no more than a total of 2 injections will be given (for macular degeneration up to 4 injections per year are administered)

    Subject analysis set title
    Treatment group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This single centre pilot study will include the identification of 10-20 patients from the routine corneal clinics presenting with corneal neovascularisation non responsive or not suitable for steroid therapy.

    Primary: Cessation or reduction of corneal neovascularisation with Ranibizumab (Lucentis®) treatment

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    End point title
    		 Cessation or reduction of corneal neovascularisation with Ranibizumab (Lucentis®) treatment
    End point description
    Digital photographs of the cornea will be analysed by 2 blind observers and image analysis will be used to determine the area of cornea covered by neovascularisation as a percentage of the total corneal area.
    End point type
    Primary
    End point timeframe
    Patients will be monitored fortnightly for the first month and then at months 2, 4 and 6.
    End point values
    		 Treatment group Treatment group
    Number of subjects analysed
    6
    6
    Units: Area of neovascularisation
    6
    6
    Statistical analysis title
    		 Descriptive analysis
    Statistical analysis description
    The study was not completed, however some conclusions were drawn through descriptive analysis.
    Comparison groups
    Treatment group v Treatment group
    Number of subjects included in analysis
    12
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05 [2]
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [1] - Lucentis has a short effect that can not be maintained with the presence of active corneal inflammation. As long as the stimulus for vascularisation is not addressed measures to reduce the vessels have only a temporary effect. One injection is not sufficient and several may be required during the course of the disease process. Subconjunctival use of Lucentis is safe and multiple injections can be given safely.
    [2] - Statistical analysis was not performed as the study was not completed

    Secondary: To determine whether established corneal vessels too would be influenced with Ranibizumab and whether there is any gain in visual acuity following ‘regression’ of corneal new vessels.

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    End point title
    		 To determine whether established corneal vessels too would be influenced with Ranibizumab and whether there is any gain in visual acuity following ‘regression’ of corneal new vessels.
    End point description
    On each visit relevant systemic and visual history will be taken then visual acuity, pupil reaction, anterior segment biomicroscopic examination, fundal examination and intraocular pressure measurement will be undertaken and a standard anterior eye segment photograph will be taken at each visit.
    End point type
    Secondary
    End point timeframe
    Patients will be monitored fortnightly for the first month and then at months 2, 4 and 6.
    End point values
    		 Treatment group Treatment group
    Number of subjects analysed
    6
    6
    Units: LogMar units
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All serious adverse events that fall or are suspected to fall within these criteria shall be treated as a SUSAR until deemed otherwise. The event shall be reported immediately of knowledge of its occurrence to the Chief Investigator
    Adverse event reporting additional description
    Participants will be asked to contact the study site immediately in the event of any serious adverse event. All adverse events will be recorded and closely monitored until resolution, stabilisation, or until it has been shown that the study medication or treatment is not the cause.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only 6 patients were treated and there were no reported adverse events.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2010
    MHRA requested a justification for the dose of Lucentis and the protocol was changed accordingly

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The target was to recruit 20 participants however only 6 were recruited.
    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.

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