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    Clinical Trial Results:
    24-month, multicenter, open-label, phase lllb study to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

    Summary
    EudraCT number
    		 2013-002850-54
    Trial protocol
    		 FR  
    Global end of trial date
    29 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2016
    First version publication date
    30 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRFB002DFR11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02032173
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    29 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary study objective was to evaluate the proportion of patients presenting with stable BCVA after 24 months compared to the BCVA value observed at 6 months (difference :S 4 letters lost between the BCVA scores recorded at 6 and 24 months) when the follow-up period is spaced out after an intensive treatment phase
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 May 2014
    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
    France: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    14
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 39 patients were screened by 10 centers. 8 of the 39 screened patients were not included in the treatment phase.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ranibizumab
    Arm description
    		 0.5mg in 0.05ml
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ranibizumab
    Investigational medicinal product code
    RFB002
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Ranibizumab 0.5mg

    Number of subjects in period 1
    		Ranibizumab
    Started
    31
    Completed
    0
    Not completed
    31
         Discontinuation due to sponsor decision
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 0.5mg in 0.05ml

    Reporting group values
    		 Ranibizumab Total
    Number of subjects
    		 31 31
    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)
    		 14 14
        From 65-84 years
    		 17 17
        85 years and over
    		 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 64.7 ± 7.08 -
    Gender, Male/Female
    Units: Participants
        Female
    		 10 10
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    Ranibizumab
    Reporting group description
    		 0.5mg in 0.05ml

    Primary: Rate of patients with a stable BCVA at 24 months compared with BCVA at 6 months

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    End point title
    		 Rate of patients with a stable BCVA at 24 months compared with BCVA at 6 months [1]
    End point description
    Best-Corrected Visual Acuity (BCVA) is measured using an Early Treatment of Diabetic Retinopathy Study scale (ETDRS scale) at 4m. The BCVA score at 6 and 24 months visits will be used. The rate of patients with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) will be calculated as well as its confidence interval at 95%
    End point type
    Primary
    End point timeframe
    6 months and 24 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Efficacy was not powered for analysis due to low enrollment. Therefore no data were analyzed for this outcome measure
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Rate of patients with a stable BCVA at 24 months compared with BCVA at 11 months

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    End point title
    		 Rate of patients with a stable BCVA at 24 months compared with BCVA at 11 months
    End point description
    BCVA is measured using an ETDRS scale at 4m. The BCVA score at 11 and 24 months visits will be used. The rate of patients with a stable BCVA (BCVA score at 11 months minus BCVA score at 24 months ≤4 letters) will be calculated.
    End point type
    Secondary
    End point timeframe
    month 11 and month 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Rate of patients keeping a BCVA score gain ≥10 letters

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    End point title
    		 Rate of patients keeping a BCVA score gain ≥10 letters
    End point description
    The rates of patients with a BCVA score ≥10 letters for each of the following visits (months 3, 6, 8, 11, 14, 17, 20, 23 and 24) compared with baseline (day 0) will be calculated.
    End point type
    Secondary
    End point timeframe
    baseline, months 3, 6, 8, 11, 14, 17, 20, 23 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Rate of patients keeping a BCVA score gain ≥15 letters

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    End point title
    		 Rate of patients keeping a BCVA score gain ≥15 letters
    End point description
    The rates of patients with a BCVA score ≥15 letters for each of the following visits (months 3, 6, 8, 11, 14, 17, 20, 23 and 24) compared with baseline (day 0) will be calculated.
    End point type
    Secondary
    End point timeframe
    baseline, months 3, 6, 8, 11, 14, 17, 20, 23 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: BCVA mean absolute variation from baseline to 24 months

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    End point title
    		 BCVA mean absolute variation from baseline to 24 months
    End point description
    BCVA scores for all visits between baseline and month 24 from both main and rescue groups are recorded. The mean absolute variations are calculated from baseline score.
    End point type
    Secondary
    End point timeframe
    Baseline, months 1, 2, 3, 4, 5, 6, 8, 11, 14, 17, 20, 23 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: score
    0
    No statistical analyses for this end point

    Secondary: Central Subfield Thickness (CST) evaluation

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    End point title
    		 Central Subfield Thickness (CST) evaluation
    End point description
    The absolute variations of the Central Subfield Thickness (CST) measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit is calculated from baseline score and for both main and rescue groups. Values can also be calculated as a log OCT (=log[CST/200]).
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 2, 3, 4, 5, 6, 8, 11, 14, 17, 20, 23 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    0 [2]
    Units: log
        log mean (confidence interval 95%)
    ( to )
    Notes
    [2] - Efficacy was not powered for analysis due to low enrollment
    No statistical analyses for this end point

    Secondary: Effect of follow-up change on CST and BCVA in rescue group

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    End point title
    		 Effect of follow-up change on CST and BCVA in rescue group
    End point description
    Change of CST and BCVA score of patients from the rescue group.
    End point type
    Secondary
    End point timeframe
    months 6, 12, 18 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: ETDRS letters
        arithmetic mean (standard deviation)
    0 ± 0
    No statistical analyses for this end point

    Secondary: Rate of patients with a BCVA loss ≥15 letters compared with month 6

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    End point title
    		 Rate of patients with a BCVA loss ≥15 letters compared with month 6
    End point description
    The rate of patients with a BCVA loss ≥15 letters compared with month 6 BCVA score leading to a change of group (Rescue group) evaluated from each visit onwards stating at month 6.
    End point type
    Secondary
    End point timeframe
    Months 6, 8, 11, 14, 17, 20, 23 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: letters
    0
    No statistical analyses for this end point

    Secondary: Evaluation of the spaced out follow-up on visual functions and quality of life

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    End point title
    		 Evaluation of the spaced out follow-up on visual functions and quality of life
    End point description
    The global score obtained on the Visual Function Questionnaire 25 (VFQ 25) will be compared from baseline to months 11 and 24 for the Main group and from baseline to months 12 and 24 for the Rescue group.
    End point type
    Secondary
    End point timeframe
    baseline, months 11, 12 and 24
    End point values
    		 Ranibizumab
    Number of subjects analysed
    31
    Units: score
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Ranibizumab 0.5 mg
    Reporting group description
    		 Ranibizumab 0.5 mg

    Serious adverse events
    		 Ranibizumab 0.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 31 (6.45%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ranibizumab 0.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 31 (9.68%)
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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    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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