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    Clinical Trial Results:
    Extension study for the follow up of patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulated controlled treatment to evaluate safety and efficacy of intravitreal etamsilato code OFT-ETAMSILATO -4.2.1

    Summary
    EudraCT number
    		 2015-001812-36
    Trial protocol
    		 ES  
    Global end of trial date
    15 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2018
    First version publication date
    09 Aug 2018
    Other versions
    Summary report(s)
    		 CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    OFT-ETAMSILATO-4.2.3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Investigacion Independiente
    Sponsor organisation address
    C/ Cuesta del Sagrado Corazón nº 4, Madrid, Madrid, Spain, 28016
    Public contact
    Rocio Garcia Cañamaque, Leon Research S.L., 0034 987261 064, rgcanamaque@leonresearch.es
    Scientific contact
    Rocio Garcia Cañamaque, Leon Research S.L., 0034 987261 064, rgcanamaque@leonresearch.es
    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
    01 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluate the effect of treatment received in the previous clinical trial (intravitreal ethamsylate or simulated treatment) in improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease after a non-interventionist tracking "treated eye" in the clinical trial until the week 48 of the double blinded treatment administration.
    Protection of trial subjects
    To avoid having discomfort or pain with the injection in the eye (intravitreal), an anesthetic eye drop will be applied. Thus, the patient will not feel any pain or discomfort (PATIENTS WILL NOT BE ABLE TO DISTINGUISH IF THEY RECEIVE A REAL OR SIMULATED INJECTION)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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
    Spain: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    5
    From 65 to 84 years
    30
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 The present report presents the clinical results of a complete study, including three clinical trials, with patients recruited in a period of 24 months approximately. The PI will recruit patients, in chronological order according to their private consultation, when they meet the selection criteria specified in the study protocol

    Pre-assignment
    Screening details
    		 Patients who are included in the study MUST meet all the inclusion criteria and MUST NOT present any of the exclusion criteria. Database includes 48 patients, of which 4 of them were finally not considered as they were screen failures.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Patients will not know what treatment they receive. In the control group, the specialist will simulate giving them the injection, using a blunt needle that does not penetrate the eyeball. The specialist who evaluates the patients (interpreting the data required for this study) will not know what treatment each patient has received. Therefore, it is not the same specialist who administers the treatments, since he / she would know which injections are real or which are feigned

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 Patients receive etamsylate administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    DICYNONE 250 mg/2 ml
    Investigational medicinal product code
    PRD437914
    Other name
    B02BX01
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    A single intravitreal injection of 18.75 mg of etamsylate (150 μL).

    Arm title
    		 Control
    Arm description
    		 The specialist will simulate giving patients the injection, using a blunt needle that does not penetrate the eyeball
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Treatment Control
    Started
    21
    23
    Completed
    16
    15
    Not completed
    5
    8
         Consent withdrawn by subject
    3
    -
         Protocol deviation
    2
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Patients receive etamsylate administration

    Reporting group title
    Control
    Reporting group description
    		 The specialist will simulate giving patients the injection, using a blunt needle that does not penetrate the eyeball

    Reporting group values
    		 Treatment Control Total
    Number of subjects
    		 21 23 44
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 76.286 ( 10.5363 ) 78.087 ( 10.4920 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 19 36
        Male
    		 4 4 8
    eye to try selected
    Units: Subjects
        Left
    		 10 14 24
        Right
    		 11 9 20
    AMD type
    Units: Subjects
        Dry
    		 7 8 15
        Exudative
    		 14 15 29
    Ethnicity
    Units: Subjects
        White / Caucasian
    		 21 22 43
        No data
    		 0 1 1
    Employment situation
    Units: Subjects
        Work
    		 0 1 1
        Retired
    		 18 21 39
        No data
    		 3 1 4
    Family history with AMD
    Units: Subjects
        Yes
    		 3 0 3
        No
    		 18 23 41
    Smoking habit
    Units: Subjects
        former smoker
    		 6 6 12
        smoker
    		 1 0 1
        non smoker
    		 13 16 29
        No data
    		 1 1 2
    systemic pathologies
    Units: Subjects
        Any
    		 12 10 22
        High Blood Pressure (HBP)
    		 2 2 4
        Diabetes (DBT)
    		 0 1 1
        Chronic obstructive pulmonary disease (COPD)
    		 0 1 1
        Cardiovascular disease (CVD)
    		 1 0 1
        HIPERCOLESTEROLEMIA (HCOL)
    		 2 1 3
        Osteoporosis (OST)
    		 1 0 1
        HBP/HCOL
    		 0 3 3
        DTB / HBP / CVD
    		 0 1 1
        DTB / HBP/ CVD / HCOL
    		 0 1 1
        DTB / HBP/ HCOL
    		 0 1 1
        HBP/ HCOL
    		 2 0 2
        No data
    		 1 2 3
    LogMAR
    Logarithm of the Minimum Angle of Resolution. The visual reference angle is 20/20, which is the normal view, or the standard value, corresponding to a zero value of logMAR
    Units: LogMAR
        arithmetic mean (standard deviation)
    		 0.5515 ( 0.38043 ) 0.6255 ( 0.27131 ) -
    punctuation by letters
    Indicates the number of letters that are identified correctly. The higher this score, the better the visual acuity
    Units: Number of letters
        arithmetic mean (standard deviation)
    		 54 ( 14.2478 ) 49.100 ( 12.6070 ) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Patients receive etamsylate administration

    Reporting group title
    Control
    Reporting group description
    		 The specialist will simulate giving patients the injection, using a blunt needle that does not penetrate the eyeball

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    During the entire study, only one patient presented an Adverse Event (control group): elevated intraocular pressure

    Subject analysis set title
    Analysis group by intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    valid assessment of visual acuity

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    There are a large number of patients with significant deviations, so we have to work with the analysis group per protocol, evaluable patients who meet the inclusion criteria and perform a valid follow-up

    Primary: Efficacy at 4 weeks

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    End point title
    		 Efficacy at 4 weeks
    End point description
    End point type
    Primary
    End point timeframe
    To establish efficacy at 4 weeks of a single intravitreal injection of etamsylate in the improvement of visual acuity in patients diagnosed with dry or exudative DMAE
    End point values
    		 Treatment Control
    Number of subjects analysed
    16
    15
    Units: Percentage
        success
    10
    13
        failure
    6
    2
    Statistical analysis title
    		 Chi-Squared
    Statistical analysis description
    The "treatment success" is defined as the improvement of the best corrected visual acuity of 1 or more letters in the ETDRS optotype in relation to the baseline value. "Treatment failure" is defined as opposed to "treatment success" as the absence of changes in the best corrected visual acuity or the loss of 1 or more letters in the ETDRS optotype in relation to the baseline value. Efficacy is assessed in relation to the proportion of patients who present "treatment success" in week 4
    Comparison groups
    Treatment v Control
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.025
    Method
    		 Chi-squared
    Parameter type
    		 Proportion
    Confidence interval
    Notes
    [1] - If only the superiority of etamsylate can be demonstrated by proportion of successes, the result of the study will be considered positive

    Secondary: efficacy at 16 weeks

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    End point title
    		 efficacy at 16 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Evaluate the efficacy at 16 weeks of a single intravitreal injection of etamsylate in improving visual acuity in patients diagnosed with dry or exudative AMD
    End point values
    		 Treatment Control
    Number of subjects analysed
    12
    11
    Units: Percentage
        success
    7
    9
        failure
    5
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the duration of the study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    overall study
    Reporting group description
    		 -

    Serious adverse events
    		 overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.02%
    Non-serious adverse events
    		 overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 44 (2.27%)
    Eye disorders
    elevated intraocular pressure
    Additional description: Patient from the control group with dry AMD. He was treated with "Sanfor"
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2016
    Reduction of visits

    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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