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    Clinical Trial Results:
    LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 µg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.

    Summary
    EudraCT number
    		 2019-003638-18
    Trial protocol
    		 IT  
    Global end of trial date
    14 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2023
    First version publication date
    09 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    010906IN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03711929
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Santen Pharmaceuticals
    Sponsor organisation address
    6401 Hollis Street, Suite 125, Emeryville, United States,
    Public contact
    VP, Vitreous & Retina TA Strategy, Santen Incorporated, +1 447485321710, salman.anzer@santen.com
    Scientific contact
    VP, Vitreous & Retina TA Strategy, Santen Incorporated, 7485321710 447485321710, salman.anzer@santen.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
    14 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of intravitreal injection of 440 µg DE-109 every 2 months as compared with sham.
    Protection of trial subjects
    Informed consent was being obtained in compliance with "21 CFR Part 50.25 – PROTECTION OF HUMAN SUBJECTS, Elements of Informed Consent". Subjects were assigned a unique identifier by Santen. Any subject records or datasets that are transferred to Santen contained the identifier only; subject names or any information which would make the subject identifiable were not be transferred.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    United States: 71
    Country: Number of subjects enrolled
    Argentina: 24
    Country: Number of subjects enrolled
    India: 45
    Worldwide total number of subjects
    145
    EEA total number of subjects
    5
    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)
    126
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 340 subjects were enrolled, of whom 146 were randomized into the double-masked portion of the study; 16 subjects discontinued from the study before completion of the Month 5 (Exit) visit. A total of 194 subjects were considered screen failure. A total of 103subjects enrolled into the open-label period, 19 of whom discontinued.

    Pre-assignment period milestones
    Number of subjects started
    		 145
    Number of subjects completed
    		 145

    Period 1
    Period 1 title
    Double-Masked Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test Arm: DE-109 Injectable Solution
    Arm description
    		 DE-109 Injectable Solution Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DE-109
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    DE-109 440 μg IVT injection

    Arm title
    		 Sham Procedure
    Arm description
    		 Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
    Arm type
    		 Control Arm

    Investigational medicinal product name
    Sham Procedure
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The sham procedure mimics an intravitreal injection without penetrating the eye.

    Arm title
    		 Dummy Arm: DE-109 Injectable Solution
    Arm description
    		 Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm (which has the same route of administration and frequency as the test arm).
    Arm type
    		 Dummy Arm

    Investigational medicinal product name
    DE-109
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)

    Number of subjects in period 1
    		Test Arm: DE-109 Injectable Solution Sham Procedure Dummy Arm: DE-109 Injectable Solution
    Started
    57
    59
    29
    Completed
    51
    48
    24
    Not completed
    6
    11
    5
         Study terminated
    3
    8
    3
         Consent withdrawn by subject
    -
    1
    -
         Adverse Event
    -
    -
    1
         Adverse event, non-fatal
    1
    1
    -
         Other
    1
    -
    -
         Non- compliance with Study Drug
    1
    -
    -
         Lost to follow-up
    -
    1
    1
    Period 2
    Period 2 title
    Open-Label Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test Arm: DE-109 Injectable Solution
    Arm description
    		 DE-109 Injectable Solution Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DE-109
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    440 ug of DE-109 Injectable Solution

    Arm title
    		 Sham Procedure
    Arm description
    		 Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
    Arm type
    		 Control Arm

    Investigational medicinal product name
    Sham Procedure
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The sham procedure mimics an intravitreal injection without penetrating the eye.

    Arm title
    		 Dummy Arm: DE-109 Injectable Solution
    Arm description
    		 Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
    Arm type
    		 Dummy Arm

    Investigational medicinal product name
    DE-109
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)

    Number of subjects in period 2 [1]
    		Test Arm: DE-109 Injectable Solution Sham Procedure Dummy Arm: DE-109 Injectable Solution
    Started
    42
    40
    21
    Completed
    34
    35
    15
    Not completed
    8
    5
    6
         Study terminated
    5
    4
    4
         Consent withdrawn by subject
    1
    1
    1
         Other
    -
    -
    1
         LTF
    2
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Some participants exited the study after Double-Masked Treatment period at month 6, hence, less participants entered the Open-Label Treatment Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test Arm: DE-109 Injectable Solution
    Reporting group description
    		 DE-109 Injectable Solution Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4)

    Reporting group title
    Sham Procedure
    Reporting group description
    		 Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.

    Reporting group title
    Dummy Arm: DE-109 Injectable Solution
    Reporting group description
    		 Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm (which has the same route of administration and frequency as the test arm).

    Reporting group values
    		 Test Arm: DE-109 Injectable Solution Sham Procedure Dummy Arm: DE-109 Injectable Solution Total
    Number of subjects
    		 57 59 29 145
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 47 52 27 126
        From 65-84 years
    		 10 7 2 19
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.8 ± 17.26 46.2 ± 14.40 47 ± 14.27 -
    Gender categorical
    Units: Subjects
        Female
    		 36 35 14 85
        Male
    		 21 24 15 60
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 19 18 11 48
        Black or African American
    		 8 7 6 21
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 1
        White
    		 29 33 12 74
        Other
    		 0 1 0 1
    Region of Enrollment
    Units: Subjects
        Argentina
    		 12 9 3 24
        United States
    		 26 31 14 71
        Italy
    		 1 3 1 5
        India
    		 18 16 11 45

    End points

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    End points reporting groups
    Reporting group title
    Test Arm: DE-109 Injectable Solution
    Reporting group description
    		 DE-109 Injectable Solution Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4)

    Reporting group title
    Sham Procedure
    Reporting group description
    		 Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.

    Reporting group title
    Dummy Arm: DE-109 Injectable Solution
    Reporting group description
    		 Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm (which has the same route of administration and frequency as the test arm).
    Reporting group title
    Test Arm: DE-109 Injectable Solution
    Reporting group description
    		 DE-109 Injectable Solution Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4)

    Reporting group title
    Sham Procedure
    Reporting group description
    		 Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.

    Reporting group title
    Dummy Arm: DE-109 Injectable Solution
    Reporting group description
    		 Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).

    Primary: VH 0 Response at Month 5

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    End point title
    		 VH 0 Response at Month 5 [1] [2]
    End point description
    Response rates are DE-109 (15.7%), sham (12.2%) and DE-109 fixed dose (28.7%). Rate differences between Sham and other groups are reported as results.
    End point type
    Primary
    End point timeframe
    VH 0 Response at Month 5
    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: There are no statistical analyses for Open-Label Treatment period.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There is no data point for the Sham arm because the Test and Dummy arms are percent Rate Difference from the Sham arm.
    End point values
    		 Test Arm: DE-109 Injectable Solution Dummy Arm: DE-109 Injectable Solution
    Number of subjects analysed
    57 [3]
    29 [4]
    Units: Rate Difference
        arithmetic mean (standard error)
    3.8 ± 6.9
    16.1 ± 10.2
    Notes
    [3] - 65 eyes are analyzed as FAS.
    [4] - 32 eyes are analyzed as FAS.
    No statistical analyses for this end point

    Secondary: Composite score at Month 5

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    End point title
    		 Composite score at Month 5 [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Composite Score at Month 5
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There is no data point for the Sham arm because the Test and Dummy arms are percent Rate Difference from the Sham arm.
    End point values
    		 Test Arm: DE-109 Injectable Solution Dummy Arm: DE-109 Injectable Solution
    Number of subjects analysed
    57 [6]
    29 [7]
    Units: Mean Difference
        arithmetic mean (standard error)
    0.1 ± 0.2
    0.4 ± 0.3
    Notes
    [6] - 65 eyes are analyzed as FAS.
    [7] - 32 eyes are analyzed as FAS.
    No statistical analyses for this end point

    Secondary: VH 0 Response at Month 3

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    End point title
    		 VH 0 Response at Month 3 [8]
    End point description
    Response rates are DE-109 (14.7%), sham (5.5%) and DE-109 fixed dose (15.4%). Rate differences between Sham and other groups are reported as results.
    End point type
    Secondary
    End point timeframe
    VH 0 Response at Month 3
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There is no data point for the Sham arm because the Test and Dummy arms are percent Rate Difference from the Sham arm.
    End point values
    		 Test Arm: DE-109 Injectable Solution Dummy Arm: DE-109 Injectable Solution
    Number of subjects analysed
    57 [9]
    29 [10]
    Units: Rate Difference
        arithmetic mean (standard error)
    9.2 ± 5.6
    9.7 ± 8.0
    Notes
    [9] - 65 eyes are analyzed as FAS.
    [10] - 32 eyes are analyzed as FAS.
    No statistical analyses for this end point

    Secondary: Composite score at Month 3

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    End point title
    		 Composite score at Month 3 [11]
    End point description
    End point type
    Secondary
    End point timeframe
    Composite score at Month 3
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There is no data point for the Sham arm because the Test and Dummy arms are percent Rate Difference from the Sham arm.
    End point values
    		 Test Arm: DE-109 Injectable Solution Dummy Arm: DE-109 Injectable Solution
    Number of subjects analysed
    57 [12]
    29 [13]
    Units: Mean Difference
        arithmetic mean (standard error)
    0.2 ± 0.2
    0.2 ± 0.2
    Notes
    [12] - 65 eyes are analyzed as FAS.
    [13] - 32 eyes are analyzed as FAS.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events in this study were collected from the time of informed consent and until subject withdrew or the scheduled exit visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Double Masked -DE-109 440 μg
    Reporting group description
    		 -

    Reporting group title
    Double Masked- Sham
    Reporting group description
    		 -

    Reporting group title
    Double Masked- DE-109 Fixed Dose
    Reporting group description
    		 -

    Reporting group title
    Open Label -DE-109 440 μg
    Reporting group description
    		 -

    Reporting group title
    Open Label- Sham
    Reporting group description
    		 -

    Reporting group title
    Open Label- DE-109 Fixed Dose
    Reporting group description
    		 This reporting group has 13 subject affected by non-adverse events, however 7 is entered as subjects affected by non-serious adverse events. The threshold for reporting non-serious adverse events is 5%, therefore 7 subjects are reported and 6 subjects are not needed to report. However, system validation notified the error message "The total number of subjects affected by the non-serious adverse events is less than the total number of subjects affected by non-serious adverse events for the reporting group. Account for all subjects affected or correct the total number of subjects for the reporting group". Therefore, the number of subjects was entered 7.

    Serious adverse events
    		 Double Masked -DE-109 440 μg Double Masked- Sham Double Masked- DE-109 Fixed Dose Open Label -DE-109 440 μg Open Label- Sham Open Label- DE-109 Fixed Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 57 (12.28%)
    3 / 59 (5.08%)
    5 / 29 (17.24%)
    3 / 42 (7.14%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Toxic anterior segment syndrome
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Strangulated hernia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    1 / 42 (2.38%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    1 / 42 (2.38%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    2 / 29 (6.90%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Birdshot chorioretinopathy
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 59 (1.69%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-infectious endophthalmitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    1 / 42 (2.38%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 59 (1.69%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Endophthalmitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chorioretinitis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 59 (1.69%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye abscess
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double Masked -DE-109 440 μg Double Masked- Sham Double Masked- DE-109 Fixed Dose Open Label -DE-109 440 μg Open Label- Sham Open Label- DE-109 Fixed Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 57 (82.46%)
    45 / 59 (76.27%)
    22 / 29 (75.86%)
    31 / 42 (73.81%)
    25 / 40 (62.50%)
    8 / 21 (38.10%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    15 / 57 (26.32%)
    8 / 59 (13.56%)
    3 / 29 (10.34%)
    9 / 42 (21.43%)
    8 / 40 (20.00%)
    1 / 21 (4.76%)
         occurrences all number
    20
    9
    7
    12
    12
    1
    Product residue present
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 59 (1.69%)
    4 / 29 (13.79%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    4
    1
    5
    1
    5
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 59 (0.00%)
    2 / 29 (6.90%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 59 (1.69%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    2 / 40 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    3
    2
    1
    0
    4
    0
    Eye disorders
    Uveitis
         subjects affected / exposed
    9 / 57 (15.79%)
    12 / 59 (20.34%)
    5 / 29 (17.24%)
    5 / 42 (11.90%)
    4 / 40 (10.00%)
    2 / 21 (9.52%)
         occurrences all number
    12
    16
    5
    6
    5
    3
    Cystoid macular oedema
         subjects affected / exposed
    6 / 57 (10.53%)
    11 / 59 (18.64%)
    1 / 29 (3.45%)
    3 / 42 (7.14%)
    4 / 40 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    8
    14
    2
    4
    5
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    7 / 57 (12.28%)
    5 / 59 (8.47%)
    4 / 29 (13.79%)
    6 / 42 (14.29%)
    4 / 40 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    7
    5
    5
    9
    4
    2
    Iridocyclitis
         subjects affected / exposed
    7 / 57 (12.28%)
    4 / 59 (6.78%)
    3 / 29 (10.34%)
    2 / 42 (4.76%)
    2 / 40 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    8
    4
    4
    2
    3
    1
    Cataract
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 59 (1.69%)
    4 / 29 (13.79%)
    4 / 42 (9.52%)
    3 / 40 (7.50%)
    0 / 21 (0.00%)
         occurrences all number
    5
    1
    5
    4
    3
    0
    Cataract subcapsular
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 59 (5.08%)
    3 / 29 (10.34%)
    2 / 42 (4.76%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         occurrences all number
    4
    5
    3
    4
    2
    0
    Eye pain
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 59 (1.69%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    2 / 40 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    4
    1
    2
    0
    5
    1
    Macular oedema
         subjects affected / exposed
    1 / 57 (1.75%)
    4 / 59 (6.78%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         occurrences all number
    1
    5
    2
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         occurrences all number
    7
    0
    2
    0
    2
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 59 (5.08%)
    0 / 29 (0.00%)
    0 / 42 (0.00%)
    4 / 40 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    7
    0
    0
    5
    1
    Iris adhesions
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 59 (1.69%)
    2 / 29 (6.90%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    2
    1
    2
    0
    Visual impairment
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 59 (0.00%)
    1 / 29 (3.45%)
    3 / 42 (7.14%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    1
    4
    0
    0
    Eye irritation
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 59 (0.00%)
    2 / 29 (6.90%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    2
    0
    2
    0
    Keratic precipitates
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 59 (3.39%)
    2 / 29 (6.90%)
    1 / 42 (2.38%)
    1 / 40 (2.50%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    2
    1
    2
    0
    Infections and infestations
    Chorioretinitis
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 59 (8.47%)
    1 / 29 (3.45%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    8
    2
    2
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2021
    Protocol Amendment

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Jun 2022
    Study was terminated for business reasons.
    -

    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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