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    Clinical Trial Results:
    Single and Repeat Dose Study of the Safety and Efficacy of AGN-150998 in Patients with Exudative Age-related Macular Degeneration

    Summary
    EudraCT number
    2011-002526-43
    Trial protocol
    DE   AT   IT  
    Global end of trial date
    09 Apr 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Apr 2016
    First version publication date
    08 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    150998-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01397409
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan, Inc
    Sponsor organisation address
    2525 Dupont Drive, Irvine, United States, 92612
    Public contact
    Medical Director, Allergan, +1 714-246-4500, clinicaltrials@allergan.com
    Scientific contact
    Medical Director, Allergan, +1 714-246-4500, clinicaltrials@allergan.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
    17 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was conducted in 3 stages. Stage 1 was an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 were randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication was administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives were (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.
    Protection of trial subjects
    All participants were required to read an sign an informed consent form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Sep 2011
    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 States: 167
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Israel: 25
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Australia: 23
    Country: Number of subjects enrolled
    Switzerland: 12
    Country: Number of subjects enrolled
    Austria: 10
    Worldwide total number of subjects
    271
    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)
    16
    From 65 to 84 years
    201
    85 years and over
    54

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled in 43 study centers in 8 countries: Austria, Australia, France, Germany, Israel, Italy, Switzerland and the United States from 29 September 2011 to 09 April 2014.

    Pre-assignment
    Screening details
    Patients with Age-related Macular Degeneration enrolled in the Stage 1 open label dose escalation study starting at a 1.0 mg dose. In Stage 2, patients were randomized in a 1:1:1 ratio to ranibizumab, 3.0 mg abicipar or 4.2 mg abicipar. In Stage 3, patients were randomized in a 3:3:2 ratio of 1.0 mg abicipar, 2.0 mg abicipar or 0.5 mg ranibizumab.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Stage 1: AGN-150998 4.2 mg
    Arm description
    Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 1: AGN-150998 3.0 mg
    Arm description
    Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 1: AGN-150998 2.0 mg
    Arm description
    Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 1: AGN-150998 1.0 mg
    Arm description
    Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 2: AGN-150998 4.2 mg
    Arm description
    Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 2: AGN-150998 3.0 mg
    Arm description
    Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 2: Ranibizumab 0.5 mg
    Arm description
    Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
    Arm type
    Active comparator

    Investigational medicinal product name
    ranibizumab
    Investigational medicinal product code
    Other name
    Lucentis®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intavitreal injection

    Arm title
    Stage 3: AGN-150998 2.0 mg
    Arm description
    Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 3: AGN-150998 1.0 mg
    Arm description
    Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
    Arm type
    Experimental

    Investigational medicinal product name
    AGN-150998
    Investigational medicinal product code
    Other name
    abicipar
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intravitreal injection

    Arm title
    Stage 3: Ranibizumab 0.5 mg
    Arm description
    Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
    Arm type
    Active comparator

    Investigational medicinal product name
    ranibizumab
    Investigational medicinal product code
    Other name
    Lucentis®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Single intavitreal injection

    Number of subjects in period 1
    Stage 1: AGN-150998 4.2 mg Stage 1: AGN-150998 3.0 mg Stage 1: AGN-150998 2.0 mg Stage 1: AGN-150998 1.0 mg Stage 2: AGN-150998 4.2 mg Stage 2: AGN-150998 3.0 mg Stage 2: Ranibizumab 0.5 mg Stage 3: AGN-150998 2.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: Ranibizumab 0.5 mg
    Started
    9
    6
    6
    3
    67
    58
    58
    23
    25
    16
    Completed
    9
    6
    6
    3
    59
    54
    58
    21
    25
    16
    Not completed
    0
    0
    0
    0
    8
    4
    0
    2
    0
    0
         Adverse event, non-fatal
    -
    -
    -
    -
    6
    3
    -
    1
    -
    -
         Personal Reasons
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
         Other Miscellaneous Reasons
    -
    -
    -
    -
    1
    1
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stage 1: AGN-150998 4.2 mg
    Reporting group description
    Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.

    Reporting group title
    Stage 1: AGN-150998 3.0 mg
    Reporting group description
    Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.

    Reporting group title
    Stage 1: AGN-150998 2.0 mg
    Reporting group description
    Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection

    Reporting group title
    Stage 1: AGN-150998 1.0 mg
    Reporting group description
    Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.

    Reporting group title
    Stage 2: AGN-150998 4.2 mg
    Reporting group description
    Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 2: AGN-150998 3.0 mg
    Reporting group description
    Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 2: Ranibizumab 0.5 mg
    Reporting group description
    Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 3: AGN-150998 2.0 mg
    Reporting group description
    Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.

    Reporting group title
    Stage 3: AGN-150998 1.0 mg
    Reporting group description
    Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.

    Reporting group title
    Stage 3: Ranibizumab 0.5 mg
    Reporting group description
    Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks

    Reporting group values
    Stage 1: AGN-150998 4.2 mg Stage 1: AGN-150998 3.0 mg Stage 1: AGN-150998 2.0 mg Stage 1: AGN-150998 1.0 mg Stage 2: AGN-150998 4.2 mg Stage 2: AGN-150998 3.0 mg Stage 2: Ranibizumab 0.5 mg Stage 3: AGN-150998 2.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: Ranibizumab 0.5 mg Total
    Number of subjects
    9 6 6 3 67 58 58 23 25 16 271
    Age categorical
    Units: Subjects
        Adults 18-64 years
    0 1 0 1 3 3 5 0 6 2 21
        Adults 65-84 years
    9 5 6 2 64 55 53 23 19 14 250
        Adults ≥85 years
    0 0 0 0 0 0 0 0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    82.3 (68 to 89) 75.3 (62 to 86) 79.3 (72 to 91) 67.7 (64 to 71) 80.4 (58 to 95) 78.6 (63 to 94) 78.5 (59 to 92) 77.9 (67 to 89) 75.5 (54 to 91) 76.5 (53 to 86) -
    Gender, Male/Female
    Units: Participants
        Female
    5 2 4 2 34 35 38 13 18 8 159
        Male
    4 4 2 1 33 23 20 10 7 8 112
    Subject analysis sets

    Subject analysis set title
    All Stage 1 Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Stage 1 Al lParticipants

    Subject analysis sets values
    All Stage 1 Participants
    Number of subjects
    24
    Age categorical
    Units: Subjects
        Adults 18-64 years
    0
        Adults 65-84 years
    0
        Adults ≥85 years
    0
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    0 (0 to 0)
    Gender, Male/Female
    Units: Participants
        Female
    0
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Stage 1: AGN-150998 4.2 mg
    Reporting group description
    Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.

    Reporting group title
    Stage 1: AGN-150998 3.0 mg
    Reporting group description
    Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.

    Reporting group title
    Stage 1: AGN-150998 2.0 mg
    Reporting group description
    Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection

    Reporting group title
    Stage 1: AGN-150998 1.0 mg
    Reporting group description
    Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.

    Reporting group title
    Stage 2: AGN-150998 4.2 mg
    Reporting group description
    Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 2: AGN-150998 3.0 mg
    Reporting group description
    Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 2: Ranibizumab 0.5 mg
    Reporting group description
    Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 3: AGN-150998 2.0 mg
    Reporting group description
    Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.

    Reporting group title
    Stage 3: AGN-150998 1.0 mg
    Reporting group description
    Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.

    Reporting group title
    Stage 3: Ranibizumab 0.5 mg
    Reporting group description
    Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks

    Subject analysis set title
    All Stage 1 Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Stage 1 Al lParticipants

    Primary: Highest Tolerated Dose (HTD) of AGN-150998

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    End point title
    Highest Tolerated Dose (HTD) of AGN-150998 [1]
    End point description
    Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
    End point type
    Primary
    End point timeframe
    24 Weeks
    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: No Statistical Analysis is reported for this outcome measure.
    End point values
    All Stage 1 Participants
    Number of subjects analysed
    24
    Units: mg
        number (not applicable)
    4.2
    No statistical analyses for this end point

    Primary: Stage 1: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye

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    End point title
    Stage 1: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [2] [3]
    End point description
    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    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: No Statistical Analysis is reported for this outcome measure.
    [3] - 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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 1: AGN-150998 4.2 mg Stage 1: AGN-150998 3.0 mg Stage 1: AGN-150998 2.0 mg Stage 1: AGN-150998 1.0 mg
    Number of subjects analysed
    9
    6
    6
    3
    Units: microns
    arithmetic mean (standard deviation)
        Baseline
    527.6 ( 126.79 )
    540.3 ( 284.34 )
    500.3 ( 155.65 )
    564.3 ( 115.68 )
        Change from Baseline at Week 4 (n=9,6,6,2)
    -185.4 ( 161.23 )
    -239.5 ( 234.03 )
    -212.3 ( 182.94 )
    -113.5 ( 135.06 )
    No statistical analyses for this end point

    Primary: Stage 2: Time between Baseline Treatment and Recurrence of Active Disease

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    End point title
    Stage 2: Time between Baseline Treatment and Recurrence of Active Disease [4] [5]
    End point description
    Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    Notes
    [4] - 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: No Statistical Analysis is reported for this outcome measure.
    [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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 2: AGN-150998 4.2 mg Stage 2: AGN-150998 3.0 mg Stage 2: Ranibizumab 0.5 mg
    Number of subjects analysed
    65
    57
    57
    Units: days
        median (inter-quartile range (Q1-Q3))
    59 (43 to 109)
    57 (43 to 86)
    57 (43 to 85)
    No statistical analyses for this end point

    Primary: Stage 3: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

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    End point title
    Stage 3: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [6] [7]
    End point description
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (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.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    Notes
    [6] - 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: No Statistical Analysis is reported for this outcome measure.
    [7] - 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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 3: AGN-150998 2.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: Ranibizumab 0.5 mg
    Number of subjects analysed
    23
    25
    16
    Units: letters
    arithmetic mean (standard deviation)
        Baseline
    58.5 ( 14.29 )
    58.4 ( 13.49 )
    60.4 ( 16.41 )
        Change from Baseline at Week 16
    8.2 ( 7.89 )
    6.3 ( 7.81 )
    5.3 ( 11.08 )
    No statistical analyses for this end point

    Secondary: Stage 2: Time between Second Treatment and Recurrence of Active Disease

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    End point title
    Stage 2: Time between Second Treatment and Recurrence of Active Disease [8]
    End point description
    Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1. Inter-Quartile Range High value result of 99999.99=Not estimable.
    End point type
    Secondary
    End point timeframe
    32 Weeks
    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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 2: AGN-150998 4.2 mg Stage 2: AGN-150998 3.0 mg Stage 2: Ranibizumab 0.5 mg
    Number of subjects analysed
    62
    55
    58
    Units: days
        median (inter-quartile range (Q1-Q3))
    85 (57 to 118)
    112 (60 to 99999.99)
    111 (57 to 99999.99)
    No statistical analyses for this end point

    Secondary: Stage 2: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye

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    End point title
    Stage 2: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [9]
    End point description
    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    Notes
    [9] - 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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 2: AGN-150998 4.2 mg Stage 2: AGN-150998 3.0 mg Stage 2: Ranibizumab 0.5 mg
    Number of subjects analysed
    65
    57
    57
    Units: microns
    arithmetic mean (standard deviation)
        Baseline
    524.6 ( 170.71 )
    507.3 ( 139.88 )
    497.1 ( 122.04 )
        Change from Baseline at Week 4 (n=61,56,57)
    -179.5 ( 123.76 )
    -155.3 ( 109.13 )
    -157.3 ( 121.95 )
    No statistical analyses for this end point

    Secondary: Stage 2: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

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    End point title
    Stage 2: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [10]
    End point description
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    Notes
    [10] - 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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 2: AGN-150998 4.2 mg Stage 2: AGN-150998 3.0 mg Stage 2: Ranibizumab 0.5 mg
    Number of subjects analysed
    65
    57
    57
    Units: letters
    arithmetic mean (standard deviation)
        Baseline
    54.5 ( 13.9 )
    52.7 ( 12.62 )
    55.4 ( 13 )
        Change from Baseline at Week 4 (n=62,56,57)
    4.7 ( 9.71 )
    8.4 ( 11.51 )
    5.9 ( 64 )
    No statistical analyses for this end point

    Secondary: Stage 3: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye

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    End point title
    Stage 3: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [11]
    End point description
    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 3: AGN-150998 2.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: Ranibizumab 0.5 mg
    Number of subjects analysed
    23
    25
    16
    Units: microns
    arithmetic mean (standard deviation)
        Baseline
    466 ( 125.96 )
    526.1 ( 165.09 )
    463.3 ( 94.56 )
        Change from Baseline at Week 4
    -119.8 ( 68.5 )
    -168.3 ( 137.07 )
    -98.4 ( 65.22 )
    No statistical analyses for this end point

    Secondary: Stage 3: Change from Baseline in BCVA in the Study Eye

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    End point title
    Stage 3: Change from Baseline in BCVA in the Study Eye [12]
    End point description
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    Notes
    [12] - 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: Not all arms in the baseline period are applicable to this outcome measure.
    End point values
    Stage 3: AGN-150998 2.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: Ranibizumab 0.5 mg
    Number of subjects analysed
    23
    25
    16
    Units: letters
    arithmetic mean (standard deviation)
        Baseline
    58.5 ( 14.29 )
    58.4 ( 13.49 )
    60.4 ( 16.41 )
        Change from Baseline at Week 4
    5 ( 7.4 )
    4.6 ( 5.98 )
    3.9 ( 6.01 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Stage 1: Up to 24 Weeks, Stage 2: Up to 32 Weeks and Stage 3: Up to 20 Weeks
    Adverse event reporting additional description
    Adverse Events (AEs) are analyzed and reported independently for Stage 1, Stage 2 and Stage 3, For non-serious Adverse Events, a result of 0 means there were no AEs greater than or equal to the threshold of 5% in the reporting group/arm.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Stage 1: AGN-150998 4.2 mg
    Reporting group description
    Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.

    Reporting group title
    Stage 1: AGN-150998 3.0 mg
    Reporting group description
    Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.

    Reporting group title
    Stage 1: AGN-150998 2.0 mg
    Reporting group description
    Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection

    Reporting group title
    Stage 1: AGN-150998 1.0 mg
    Reporting group description
    Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.

    Reporting group title
    Stage 2: AGN-150998 4.2 mg
    Reporting group description
    Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 2: Ranibizumab 0.5 mg
    Reporting group description
    Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 2: AGN-150998 3.0 mg
    Reporting group description
    Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

    Reporting group title
    Stage 3: AGN-150998 1.0 mg
    Reporting group description
    Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.

    Reporting group title
    Stage 3: AGN-150998 2.0 mg
    Reporting group description
    Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.

    Reporting group title
    Stage 3: Ranibizumab 0.5 mg
    Reporting group description
    Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks

    Serious adverse events
    Stage 1: AGN-150998 4.2 mg Stage 1: AGN-150998 3.0 mg Stage 1: AGN-150998 2.0 mg Stage 1: AGN-150998 1.0 mg Stage 2: AGN-150998 4.2 mg Stage 2: Ranibizumab 0.5 mg Stage 2: AGN-150998 3.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: AGN-150998 2.0 mg Stage 3: Ranibizumab 0.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    11 / 67 (16.42%)
    5 / 58 (8.62%)
    6 / 58 (10.34%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal cancer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Temporal arteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Uveitus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    3 / 67 (4.48%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anterior chamber inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 67 (2.99%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choroiditis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Stage 1: AGN-150998 4.2 mg Stage 1: AGN-150998 3.0 mg Stage 1: AGN-150998 2.0 mg Stage 1: AGN-150998 1.0 mg Stage 2: AGN-150998 4.2 mg Stage 2: Ranibizumab 0.5 mg Stage 2: AGN-150998 3.0 mg Stage 3: AGN-150998 1.0 mg Stage 3: AGN-150998 2.0 mg Stage 3: Ranibizumab 0.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 9 (33.33%)
    5 / 6 (83.33%)
    4 / 6 (66.67%)
    2 / 3 (66.67%)
    35 / 67 (52.24%)
    19 / 58 (32.76%)
    20 / 58 (34.48%)
    10 / 25 (40.00%)
    6 / 23 (26.09%)
    9 / 16 (56.25%)
    Injury, poisoning and procedural complications
    Laceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    3 / 58 (5.17%)
    3 / 58 (5.17%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    2
    5
    3
    0
    1
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Eye disorders
    Anterior chamber inflammation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Retinal pigment epithelial tear
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    9 / 67 (13.43%)
    5 / 58 (8.62%)
    3 / 58 (5.17%)
    2 / 25 (8.00%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    1
    9
    5
    5
    4
    1
    0
    Eye irritation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    5 / 67 (7.46%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    6
    2
    2
    0
    0
    0
    Anterior chamber cell
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Anterior chamber flare
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Eye pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    6 / 67 (8.96%)
    4 / 58 (6.90%)
    3 / 58 (5.17%)
    1 / 25 (4.00%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    0
    7
    6
    3
    1
    3
    1
    Hyalosis asteroid
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Macular oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Foreign body sensation in eyes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    4 / 67 (5.97%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    4
    1
    0
    1
    0
    1
    Retinal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    6 / 67 (8.96%)
    4 / 58 (6.90%)
    3 / 58 (5.17%)
    3 / 25 (12.00%)
    0 / 23 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    1
    7
    5
    3
    3
    0
    2
    Vitreous detachment
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    5 / 67 (7.46%)
    2 / 58 (3.45%)
    6 / 58 (10.34%)
    2 / 25 (8.00%)
    2 / 23 (8.70%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    5
    3
    7
    2
    3
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    5 / 67 (7.46%)
    3 / 58 (5.17%)
    3 / 58 (5.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    6
    5
    8
    0
    0
    0
    Vitritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    3 / 58 (5.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    Vitreous floaters
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    0 / 58 (0.00%)
    3 / 58 (5.17%)
    3 / 25 (12.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    3
    3
    1
    1
    Dry eye
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    1 / 58 (1.72%)
    3 / 58 (5.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    5
    0
    0
    0
    Age-related macular degeneration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Macular scar
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Choroidal neovascularisation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Ocular discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Visual impairment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract congestion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Urticaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    4 / 67 (5.97%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    2
    2
    0
    0
    0
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 67 (1.49%)
    1 / 58 (1.72%)
    3 / 58 (5.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    3
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    4 / 67 (5.97%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    0
    5
    1
    5
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    3 / 58 (5.17%)
    1 / 58 (1.72%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 67 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2011
    Amendment 1: An error in an inclusion criterion was corrected.
    05 Dec 2011
    Amendment 2: The protocol was amended to add a second injection of the study medication to assess the safety of repeat injection of the study medication and to add a cohort of Japanese patients to compare the safety, Pharmacokinetics (PK), and treatment effect of the study drug across ethnic groups.
    24 Aug 2012
    Amendment 3: The protocol was amended to add a potential interim analysis. Per protocol Population was used for Analysis. Week 16 Key Secondary time-point.
    01 May 2013
    Amendment 4: The protocol was amended to add a Stage 3 to explore the safety and effects of treatment with AGN-150998 administered at 4-week intervals on Best Corrected Visual Acuity (BCVA) and Central Retinal Thickness (CRT) versus ranibizumab.

    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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