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    Clinical Trial Results:
    A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept with Proactive Customized Treatment Intervals in Patients ≥50 Years of Age with No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation with Aflibercept

    Summary
    EudraCT number
    		 2022-000690-73
    Trial protocol
    		 DE   FR   ES  
    Global end of trial date
    11 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jul 2024
    First version publication date
    25 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-5321/21912
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05473715
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, 49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, 49 30 300139003, clinical-trials-contact@bayer.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
    11 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess whether 2 mg IVT aflibercept administered at a customized treatment interval (determined after the first extended treatment interval) is non-inferior to 2 mg IVT aflibercept administered according to a standard T&E regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for nAMD
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 2023
    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: 1
    Country: Number of subjects enrolled
    Canada: 2
    Worldwide total number of subjects
    3
    EEA total number of subjects
    0
    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)
    0
    From 65 to 84 years
    1
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study enrolled subjects in 2 countries, between 25 Apr 2023 (first subject first visit) and 11 Jul 2023 (termination date).

    Pre-assignment
    Screening details
    		 Four subjects were screened; 3 were randomized and treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Customized treatment interval
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aflibercept
    Investigational medicinal product code
    BAY 86-5321
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2 mg intravitreal (IVT) injection, initial injection was at baseline, maintain injection interval is 16 weeks.

    Arm title
    		 Standard T&E
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aflibercept
    Investigational medicinal product code
    BAY 86-5321
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2 mg IVT injection, initial injection is at baseline, maintain injection intervals is 8 weeks or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks).

    Number of subjects in period 1
    		Customized treatment interval Standard T&E
    Started
    2
    1
    Completed
    0
    0
    Not completed
    2
    1
         Trial terminate
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 3 3
    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)
    		 0 0
        From 65-84 years
    		 1 1
        85 years and over
    		 2 2
    Gender Categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Customized treatment interval
    Reporting group description
    		 -

    Reporting group title
    Standard T&E
    Reporting group description
    		 -

    Primary: Change in best-corrected visual acuity (BCVA) (early treatment diabetic retinopathy study [ETDRS] letters)

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    End point title
    		 Change in best-corrected visual acuity (BCVA) (early treatment diabetic retinopathy study [ETDRS] letters) [1]
    End point description
    Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
    End point type
    Primary
    End point timeframe
    From baseline to Week 36
    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: Descriptive statistics were done, no statistical analyses were performed.
    End point values
    		 Customized treatment interval Standard T&E
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Letter scale
        number (not applicable)
    Notes
    [2] - Study early terminated.
    [3] - Study early terminated.
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
    End point description
    AEs that occurred or worsened after the first injection of study drug and no later than 30 days after the last injection of study drug was considered as treatment-emergent adverse events (TEAEs).
    End point type
    Secondary
    End point timeframe
    Up to weeks 36 and 52
    End point values
    		 Customized treatment interval Standard T&E
    Number of subjects analysed
    2
    1
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of patients achieving pre-defined treatment intervals

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    End point title
    		 Number of patients achieving pre-defined treatment intervals
    End point description
    Pre-defined treatment intervals are: ≥4, ≥8, ≥10, ≥12¸ ≥14, and 16 weeks.
    End point type
    Secondary
    End point timeframe
    At Weeks 36 and 52
    End point values
    		 Customized treatment interval Standard T&E
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Subjects
    Notes
    [4] - Study early terminated.
    [5] - Study early terminated.
    No statistical analyses for this end point

    Secondary: Change in BCVA (ETDRS letters)

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    End point title
    		 Change in BCVA (ETDRS letters)
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 52
    End point values
    		 Customized treatment interval Standard T&E
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Letter score
        number (not applicable)
    Notes
    [6] - Study early terminated.
    [7] - Study early terminated.
    No statistical analyses for this end point

    Secondary: Number of IVT aflibercept injections per patient up to Week 52

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    End point title
    		 Number of IVT aflibercept injections per patient up to Week 52
    End point description
    Subject took aflibercept on study eye.
    End point type
    Secondary
    End point timeframe
    Up to week 52
    End point values
    		 Customized treatment interval Standard T&E
    Number of subjects analysed
    2
    1
    Units: Injections
    1
    1
    No statistical analyses for this end point

    Secondary: Number of IVT aflibercept injections per patient until Week 36

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    End point title
    		 Number of IVT aflibercept injections per patient until Week 36
    End point description
    Subject took aflibercept on study eye.
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Customized treatment interval Standard T&E
    Number of subjects analysed
    2
    1
    Units: Injections
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    After the first injection of study drug and no later than 30 days after the last injection of study drug, up to 78 days.
    Adverse event reporting additional description
    Adverse event reporting for the deaths (all causes) considers all deaths that occurred at any time during the study before the last contact, up to 78 days.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Standard T&E
    Reporting group description
    		 -

    Reporting group title
    Customized treatment interval
    Reporting group description
    		 -

    Serious adverse events
    		 Standard T&E Customized treatment interval
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard T&E Customized treatment interval
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (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: No non-serious adverse events collected due to low number of participants.

    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.
    The trial was terminated due to administrative reasons not related to efficacy or safety.
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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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