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    Clinical Trial Results:
    A PHASE 2, RANDOMIZED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS INJECTIONS OF E10030 (ANTI-PDGF PEGYLATED APTAMER) GIVEN IN COMBINATION WITH LUCENTIS® IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

    Summary
    EudraCT number
    		 2010-018741-65
    Trial protocol
    		 LV   FR   BE   DE   ES   HU   IT   AT  
    Global end of trial date
    17 Jan 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OPH1001A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01089517
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ophthotech Corporation
    Sponsor organisation address
    One Penn Plaza, New York, United States, NY 10119
    Public contact
    Jeffrey Nau, Ophthotech Corporation, 001 6465737045, jeff.nau@ophthotech.com
    Scientific contact
    Jeffrey Nau, Ophthotech Corporation, 001 6465737045, jeff.nau@ophthotech.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 Jan 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study are to evaluate the safety and efficacy profile of E10030 intravitreous injection when administered in combination with Lucentis® 0.5 mg/eye versus monotherapy Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD)
    Protection of trial subjects
    To minimize pain, on the day of injection the subjects were prepared for injection by application of single use topical anesthetic to the eye.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Apr 2010
    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: 151
    Country: Number of subjects enrolled
    Israel: 34
    Country: Number of subjects enrolled
    European Union: 254
    Country: Number of subjects enrolled
    Colombia: 10
    Worldwide total number of subjects
    449
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    25
    From 65 to 84 years
    323
    85 years and over
    101

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.

    Pre-assignment
    Screening details
    		 Subjects who had subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD), who were determined by the investigator as eligible and who provided informed consent were enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lucentis
    Arm description
    		 Sham/Lucentis
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Arm title
    		 E10030 Low Dose Plus Lucentis
    Arm description
    		 E10030 0.3 mg/Lucentis 0.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Investigational medicinal product name
    E10030
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Arm title
    		 E10030 HighDose Plus Lucentis
    Arm description
    		 E10030 1.5 mg/Lucentis 0.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Investigational medicinal product name
    E10030
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Number of subjects in period 1
    		Lucentis E10030 Low Dose Plus Lucentis E10030 HighDose Plus Lucentis
    Started
    148
    149
    152
    Completed
    148
    149
    152
    Period 2
    Period 2 title
    Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lucentis
    Arm description
    		 Sham/Lucentis
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Arm title
    		 E10030 Low Dose Plus Lucentis
    Arm description
    		 E10030 0.3 mg/Lucentis 0.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Investigational medicinal product name
    E10030
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Arm title
    		 E10030 HighDose Plus Lucentis
    Arm description
    		 E10030 1.5 mg/Lucentis 0.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Investigational medicinal product name
    E10030
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects were randomized in a 1:1:1 ratio to the following dose groups: E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye E10030 sham + Lucentis® 0. 5 mg/eye Subjects were treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

    Number of subjects in period 2
    		Lucentis E10030 Low Dose Plus Lucentis E10030 HighDose Plus Lucentis
    Started
    148
    149
    152
    Completed
    144
    144
    147
    Not completed
    4
    5
    5
         Physician decision
    -
    -
    1
         At the subjects request
    2
    4
    2
         Adverse event, non-fatal
    1
    1
    1
         Sponsor descision
    1
    -
    -
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lucentis
    Reporting group description
    		 Sham/Lucentis

    Reporting group title
    E10030 Low Dose Plus Lucentis
    Reporting group description
    		 E10030 0.3 mg/Lucentis 0.5 mg

    Reporting group title
    E10030 HighDose Plus Lucentis
    Reporting group description
    		 E10030 1.5 mg/Lucentis 0.5 mg

    Reporting group values
    		 Lucentis E10030 Low Dose Plus Lucentis E10030 HighDose Plus Lucentis Total
    Number of subjects
    		 148 149 152 449
    Age categorical
    Units: Subjects
        >= 65 years
    		 140 139 141 420
        Between 18 and 65 years
    		 8 10 11 29
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 78 ± 7.98 77.6 ± 8.19 77.8 ± 8.36 -
    Gender categorical
    Units: Subjects
        Female
    		 93 90 92 275
        Male
    		 55 59 60 174

    End points

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    End points reporting groups
    Reporting group title
    Lucentis
    Reporting group description
    		 Sham/Lucentis

    Reporting group title
    E10030 Low Dose Plus Lucentis
    Reporting group description
    		 E10030 0.3 mg/Lucentis 0.5 mg

    Reporting group title
    E10030 HighDose Plus Lucentis
    Reporting group description
    		 E10030 1.5 mg/Lucentis 0.5 mg
    Reporting group title
    Lucentis
    Reporting group description
    		 Sham/Lucentis

    Reporting group title
    E10030 Low Dose Plus Lucentis
    Reporting group description
    		 E10030 0.3 mg/Lucentis 0.5 mg

    Reporting group title
    E10030 HighDose Plus Lucentis
    Reporting group description
    		 E10030 1.5 mg/Lucentis 0.5 mg

    Primary: Mean Change in Visual Acuity From Baseline at the Week 24 Visit

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    End point title
    		 Mean Change in Visual Acuity From Baseline at the Week 24 Visit
    End point description
    The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit.
    End point type
    Primary
    End point timeframe
    24 Weeks
    End point values
    		 Lucentis E10030 Low Dose Plus Lucentis E10030 HighDose Plus Lucentis
    Number of subjects analysed
    147
    147
    151
    Units: ETDRS Letters
        arithmetic mean (standard deviation)
    6.5 ± 1.09
    8.8 ± 1.09
    10.6 ± 1.07
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    E10030 Low Dose Plus Lucentis v Lucentis v E10030 HighDose Plus Lucentis
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Lucentis
    Reporting group description
    		 Sham/Lucentis

    Reporting group title
    E10030 Low Dose Plus Lucentis
    Reporting group description
    		 E10030 0.3 mg/Lucentis 0.5 mg

    Reporting group title
    E10030 HighDose Plus Lucentis
    Reporting group description
    		 E10030 1.5 mg/Lucentis 0.5 mg

    Serious adverse events
    		 Lucentis E10030 Low Dose Plus Lucentis E10030 HighDose Plus Lucentis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 148 (8.11%)
    14 / 149 (9.40%)
    10 / 152 (6.58%)
         number of deaths (all causes)
    1
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung squamous cell carcinoma
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial disorder
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 148 (0.00%)
    2 / 149 (1.34%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 148 (0.68%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 148 (1.35%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Corneal erosion
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 149 (0.00%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Osteomyelitis
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 149 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 149 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lucentis E10030 Low Dose Plus Lucentis E10030 HighDose Plus Lucentis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 148 (63.51%)
    97 / 149 (65.10%)
    99 / 152 (65.13%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    4 / 148 (2.70%)
    8 / 149 (5.37%)
    9 / 152 (5.92%)
         occurrences all number
    5
    13
    16
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 148 (5.41%)
    7 / 149 (4.70%)
    5 / 152 (3.29%)
         occurrences all number
    8
    7
    5
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    37 / 148 (25.00%)
    34 / 149 (22.82%)
    51 / 152 (33.55%)
         occurrences all number
    80
    91
    133
    Punctate keratitis
         subjects affected / exposed
    10 / 148 (6.76%)
    19 / 149 (12.75%)
    15 / 152 (9.87%)
         occurrences all number
    25
    43
    39
    Eye pain
         subjects affected / exposed
    8 / 148 (5.41%)
    10 / 149 (6.71%)
    13 / 152 (8.55%)
         occurrences all number
    10
    12
    31
    Conjunctival hyperaemia
         subjects affected / exposed
    13 / 148 (8.78%)
    9 / 149 (6.04%)
    13 / 152 (8.55%)
         occurrences all number
    35
    21
    30
    Subretinal fibrosis
         subjects affected / exposed
    8 / 148 (5.41%)
    6 / 149 (4.03%)
    5 / 152 (3.29%)
         occurrences all number
    8
    7
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2011
    provide clarification of inclusion/exclusion criteria and fix typographical errors.
    16 Nov 2011
    primary endpoint modified to be in conformity with the primary endpoint utilized in other Phase 2 trials for wet AMD, as well as a change in the timing of this endpoint from Week 12 to Week 24.

    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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