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    Clinical Trial Results:
    A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) with Diabetic Macular Edema

    Summary
    EudraCT number
    		 2018-004785-33
    Trial protocol
    		 ES  
    Global end of trial date
    04 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2023
    First version publication date
    14 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CMO-MA-EYE-0603
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03953807
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    AbbVie, Global Medical Services, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    AbbVie, Global Medical Services, 001 8006339110, abbvieclinicaltrials@abbvie.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
    04 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study were to evaluate the efficacy and safety of OZURDEX in subjects with diabetic macular edema (DME) when used in a real world setting in Spain.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 2019
    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: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    27
    From 65 to 84 years
    45
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 75 subjects were with DME were enrolled to receive the study treatment on Day 1 and were followed up for safety up to 14 months.

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

    Arms
    Arm title
    		 OZURDEX® 700 μg
    Arm description
    		 Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OZURDEX®
    Investigational medicinal product code
    Other name
    Dexamethasone Intravitreal Implant
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Intravitreal implant administered.

    Number of subjects in period 1
    		OZURDEX® 700 μg
    Started
    75
    Completed
    55
    Not completed
    20
         Physician decision
    1
         Adverse event, non-fatal
    1
         Death
    3
         Screen failure
    1
         Lost to follow-up
    4
         Reason not specified
    3
         Protocol deviation
    6
         Withdrawal by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OZURDEX® 700 μg
    Reporting group description
    		 Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1.

    Reporting group values
    		 OZURDEX® 700 μg Total
    Number of subjects
    		 75 75
    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)
    		 67.5 ( 10.04 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 50 50

    End points

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    End points reporting groups
    Reporting group title
    OZURDEX® 700 μg
    Reporting group description
    		 Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1.

    Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at 2 Months After the Last Injection

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    End point title
    		 Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at 2 Months After the Last Injection [1]
    End point description
    BCVA was measured using an eye chart and is reported as the number of letters read correctly using the early treatment diabetic retinopathy study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A positive number indicates improvement. 'n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
    End point type
    Primary
    End point timeframe
    Baseline, at Month 10 through Month 12
    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: This is a single arm study and due to system limitation we were unable to add the statistical analysis.
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: letters
    arithmetic mean (standard deviation)
        Baseline (n=75)
    59.4 ( 14.33 )
        Change From Baseline (n=29)
    -0.7 ( 10.84 )
    No statistical analyses for this end point

    Primary: Mean Change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) After the Last Injection Received

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    End point title
    		 Mean Change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) After the Last Injection Received [2]
    End point description
    CRT is defined as the central 1000 microns from the center of the fovea and was measured using spectral domain (SD)-OCT. OCT is a laser-based, non-invasive, diagnostic system providing high-resolution imaging optical sections of the retina. A negative number indicates improvement. 'n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set included all enrolled subjects who received >=1 administration of study medication.
    End point type
    Primary
    End point timeframe
    Baseline, at Month 10 through 12
    Notes
    [2] - 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: This is a single arm study and due to system limitation we were unable to add the statistical analysis.
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: micrometer
    arithmetic mean (standard deviation)
        Baseline (n=74)
    458.6 ( 114.43 )
        Change from Baseline (n=27)
    -156.8 ( 103.16 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Second Injection

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    End point title
    		 Percentage of Subjects With Second Injection
    End point description
    Full Analysis Set included all enrolled subjects who received >=1 administration of study medication.
    End point type
    Secondary
    End point timeframe
    Up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: percentage of subjects
        number (not applicable)
    78.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Third Injection

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    End point title
    		 Percentage of Subjects With Third Injection
    End point description
    Full Analysis Set included all enrolled subjects who received >=1 administration of study medication.
    End point type
    Secondary
    End point timeframe
    Up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: percentage of subjects
        number (not applicable)
    58.7
    No statistical analyses for this end point

    Secondary: Mean Retreatment Interval in Study Eye

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    End point title
    		 Mean Retreatment Interval in Study Eye
    End point description
    First retreatment interval is defined as the number of days between the initial treatment and the first retreatment. Second retreatment interval is defined as the number of days between the first retreatment and the second retreatment. ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
    End point type
    Secondary
    End point timeframe
    From initial treatment to the first and second re-treatment to (Up to Month 14)
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: days
    arithmetic mean (standard deviation)
        First Retreatment Interval (n=59)
    140.2 ( 42.41 )
        Second Retreatment Interval (n=44)
    127.1 ( 43.64 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Number of Injections Administered

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    End point title
    		 Number of Subjects With Number of Injections Administered
    End point description
    Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
    End point type
    Secondary
    End point timeframe
    Up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: subjects
        Study Eye: 1 Injection
    16
        Study Eye: 2 Injections
    15
        Study Eye: 3 Injections
    25
        Study Eye: 4 Injections
    18
        Study Eye: 5 Injections
    0
        Study Eye: 6 Injections
    1
        Fellow Eye: 1 Injection
    9
        Fellow Eye: 2 Injections
    3
        Fellow Eye: 3 Injections
    6
        Fellow Eye: 4 Injections
    1
        Fellow Eye: 5 Injections
    0
        Fellow Eye: 6 Injections
    0
    No statistical analyses for this end point

    Secondary: AUC for BCVA

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    End point title
    		 AUC for BCVA
    End point description
    BCVA was measured using an eye chart and is reported as the number of letters read correctly using the early treatment diabetic retinopathy study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: ng.h/ml
    arithmetic mean (standard deviation)
        0 to Month 2 (n=62)
    124.1 ( 23.95 )
        0 to Month 4 (n=74)
    228.5 ( 66.62 )
        0 to Month 6 (n=74)
    350.5 ( 84.52 )
        0 to Month 8 (n=74)
    472.3 ( 105.96 )
        0 to Month 10 (n=74)
    594.8 ( 129.05 )
        0 to Month 12 (n=74)
    716.9 ( 153.79 )
        0 to Month 14 (n=74)
    838.3 ( 180.61 )
    No statistical analyses for this end point

    Secondary: Mean Change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)

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    End point title
    		 Mean Change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)
    End point description
    NEI VFQ-25 includes 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items were scored so that a high score represents better functioning. Original numeric values from the survey were recorded with the worst and best possible scores set at 0 and 100 points. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline, at Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=69)
    79.0 ( 16.77 )
        Change from Baseline (n=45)
    3.1 ( 15.98 )
    No statistical analyses for this end point

    Secondary: Area Under the Curve (AUC) for CRT

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    End point title
    		 Area Under the Curve (AUC) for CRT
    End point description
    CRT is defined as the central 1000 microns from the center of the fovea and was measured using spectral domain (SD)-OCT. OCT is a laser-based, non-invasive, diagnostic system providing high-resolution imaging optical sections of the retina. ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    75
    Units: nanogram.hour/millilitre (ng.h/ml)
    arithmetic mean (standard deviation)
        0 to Month 2 (n=61)
    764.8 ( 134.31 )
        0 to Month 4 (n=73)
    1339.9 ( 329.03 )
        0 to Month 6 (n=73)
    2063.5 ( 461.09 )
        0 to Month 8 (n=73)
    2771.3 ( 615.52 )
        0 to Month 10 (n=73)
    3482.3 ( 768.70 )
        0 to Month 12 (n=73)
    4172.3 ( 936.43 )
        0 to Month 14 (n=73)
    4852.1 ( 1135.54 )
    No statistical analyses for this end point

    Secondary: Time to Second Injection

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    End point title
    		 Time to Second Injection
    End point description
    Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Number of subjects analyzed indicates the number of subjects available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    59
    Units: days
        median (full range (min-max))
    126.0 (56 to 287)
    No statistical analyses for this end point

    Secondary: Time to Third Injection

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    End point title
    		 Time to Third Injection
    End point description
    Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Number of subjects analyzed indicates the number of subjects available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to Month 14
    End point values
    		 OZURDEX® 700 μg
    Number of subjects analysed
    44
    Units: days
        median (full range (min-max))
    245.0 (168 to 507)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to final visit (up to 14 months)
    Adverse event reporting additional description
    Safety Set consisted of all enrolled patients who received ≥1 administration of study medication/procedure.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    OZURDEX® 700 μg
    Reporting group description
    		 Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1.

    Serious adverse events
    		 OZURDEX® 700 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 75 (13.33%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    LEUKAEMIA
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    LARYNGEAL SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL NEOPLASM
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    BLOOD PRESSURE DECREASED
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SPINAL FRACTURE
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular disorders
    PERIPHERAL ISCHAEMIA
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    SHOCK HAEMORRHAGIC
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    CARDIAC FAILURE
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    COVID-19 PNEUMONIA
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENDOPHTHALMITIS
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    UROSEPSIS
         subjects affected / exposed
    1 / 75 (1.33%)
         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
    		 OZURDEX® 700 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 75 (21.33%)
    Investigations
    INTRAOCULAR PRESSURE INCREASED
         subjects affected / exposed
    9 / 75 (12.00%)
         occurrences all number
    12
    Eye disorders
    CATARACT
         subjects affected / exposed
    5 / 75 (6.67%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    4 / 75 (5.33%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2019
    Amendment 03: - Changes in Efficacy Endpoints. - Changes on Exclusion Criteria (on regards contraception and WOCBP). - Change on repeat doses. - Change on Permitted Medications (Panretinal photocoagulation) This modification does not affects reference safety information or urgent safety measure, but the scientific value of the trial.

    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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