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    Clinical Trial Results:
    A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration.

    Summary
    EudraCT number
    		 2017-004409-42
    Trial protocol
    		 HU   BG  
    Global end of trial date
    09 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Mar 2025
    First version publication date
    24 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LRP/LUBT010/2016/008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lupin Limited
    Sponsor organisation address
    Taluka-Mulshi, Pune, India,
    Public contact
    Clinical Research Unit, Lupin Limited, neelamnkardekar@lupin.com
    Scientific contact
    Clinical Research Unit, Lupin Limited, neelamnkardekar@lupin.com
    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
    12 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the equivalence in efficacy of LUBT010 to Lucentis® in terms of visual acuity, in patients with neovascular AMD.
    Protection of trial subjects
    Subjects were monitored onsite prior to and following each injection (for at least 60 minutes) to permit any early treatment and appropriate management if needed. If patient experienced red eye, sensitivity to light, pain or developed a change in vision they were instructed to seek immediate care from the study doctor or an ophthalmologist. Other medications that were considered necessary for the subject’s welfare and that were not expected to interfere with the evaluation of the study medication could be given at the discretion of the Investigator, with the exceptions: • Any systemic treatment or ocular treatment with an investigational agent • Systemic anti-VEGF therapy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2020
    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
    Poland: 162
    Country: Number of subjects enrolled
    Slovakia: 45
    Country: Number of subjects enrolled
    Bulgaria: 25
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    India: 305
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    United States: 35
    Worldwide total number of subjects
    600
    EEA total number of subjects
    241
    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)
    89
    From 65 to 84 years
    464
    85 years and over
    47

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at a total of 78 study centers in 7 countries (Bulgaria, Hungary, India, Poland, the Russian Federation, Slovakia, and the United States of America).

    Pre-assignment
    Screening details
    		 Participants who meet the eligibility criteria were randomly assigned to one of the two treatments of this study.

    Period 1
    Period 1 title
    Overall Trial (complete study duration) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Double Blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LUBT010
    Arm description
    		 LUBT010 (proposed ranibizumab biosimilar) Intravitreal injection of 0.05 mL (0.5mg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LUBT010 (proposed ranibizumab biosimilar)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg administered as intravitreal injection once every month.

    Arm title
    		 Lucentis
    Arm description
    		 Lucentis Intravitreal injection of 0.05 mL (0.5mg)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg administered as intravitreal injection once every month

    Number of subjects in period 1
    		LUBT010 Lucentis
    Started
    299
    301
    Completed
    256
    269
    Not completed
    43
    32
         Adverse event, serious fatal
    3
    4
         Physician decision
    2
    -
         Consent withdrawn by subject
    25
    17
         Adverse event, non-fatal
    6
    4
         Other
    3
    1
         Lost to follow-up
    3
    2
         Protocol deviation
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LUBT010
    Reporting group description
    		 LUBT010 (proposed ranibizumab biosimilar) Intravitreal injection of 0.05 mL (0.5mg).

    Reporting group title
    Lucentis
    Reporting group description
    		 Lucentis Intravitreal injection of 0.05 mL (0.5mg)

    Reporting group values
    		 LUBT010 Lucentis Total
    Number of subjects
    		 299 301 600
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 51 38 89
        From 65-84 years
    		 226 238 464
        85 years and over
    		 22 25 47
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.2 ( 8.75 ) 73.5 ( 7.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 151 146 297
        Male
    		 148 155 303

    End points

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    End points reporting groups
    Reporting group title
    LUBT010
    Reporting group description
    		 LUBT010 (proposed ranibizumab biosimilar) Intravitreal injection of 0.05 mL (0.5mg).

    Reporting group title
    Lucentis
    Reporting group description
    		 Lucentis Intravitreal injection of 0.05 mL (0.5mg)

    Primary: Mean change in best corrected visual acuity (BCVA) from baseline in the study eye at the end of 12 months, assessed with the ETDRS chart

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    End point title
    		 Mean change in best corrected visual acuity (BCVA) from baseline in the study eye at the end of 12 months, assessed with the ETDRS chart
    End point description
    The primary efficacy endpoint of change in BCVA from baseline in the study eye at the end of 12 months was analyzed using analysis of covariance (ANCOVA).
    End point type
    Primary
    End point timeframe
    from baseline to 12 months
    End point values
    		 LUBT010 Lucentis
    Number of subjects analysed
    295
    296
    Units: BCVA letter score (Letters)
        median (full range (min-max))
    11 (-36 to 52)
    11 (-22 to 45)
    Statistical analysis title
    		 ANCOVA model
    Statistical analysis description
    To prove the products to be biosimilar, CI (90% for United States, 95% for the rest of the world) for the difference in mean change in BCVA from baseline in the study eye at the end of 12 months, within prespecified equivalence margin.
    Comparison groups
    LUBT010 v Lucentis
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 > 0.05 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 1.88
    Variability estimate
    Standard error of the mean
    Notes
    [1] - Equivalence was met.
    [2] - There was no statistical significance between LUBT010 and Lucentis.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs occurring during the study from date of informed consent until end of study visit.
    Adverse event reporting additional description
    AEs (ocular or non-ocular) were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Details of safety analysis and split of serious adverse events and non-serious adverse events to be provided.

    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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