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    Clinical Trial Results:
    A phase 3 randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista™ (anti PDGF-b pegylated aptamer) administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal neovascular age-related macular degeneration

    Summary
    EudraCT number
    		 2013-003017-18
    Trial protocol
    		 HU   DE   ES   DK  
    Global end of trial date
    13 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2018
    First version publication date
    23 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPH1003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ophthotech Corporation
    Sponsor organisation address
    One Penn Plaza, Suite 3520, New York, United States, 10119
    Public contact
    Patricia Johnson, OPHTHOTECH CORPORATION, +1 7328907626, patricia.johnson@ophthotech.com
    Scientific contact
    Patricia Johnson, OPHTHOTECH CORPORATION, +1 7328907626, patricia.johnson@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
    19 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of intravitreal (IVT) administration of Fovista when administered in combination with IVT Lucentis compared to IVT Lucentis monotherapy, in subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
    Protection of trial subjects
    All subjects signed the informed consent form prior to undergoing study-related procedures. An independent data monitoring committee reviewed subject safety data during the course of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 23
    Country: Number of subjects enrolled
    France: 104
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Hungary: 119
    Country: Number of subjects enrolled
    Argentina: 36
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Colombia: 20
    Country: Number of subjects enrolled
    Israel: 66
    Country: Number of subjects enrolled
    Turkey: 7
    Country: Number of subjects enrolled
    United States: 197
    Worldwide total number of subjects
    627
    EEA total number of subjects
    288
    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)
    61
    From 65 to 84 years
    446
    85 years and over
    120

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study wad conducted in 101 centers in 11 countries between 05 September 2013 and 13 February 2017. Written informed consent was obtained before any of the Screening details listed below were performed.

    Pre-assignment
    Screening details
    		 Medical&ophthalmologic history,protocol refraction,visual acuity,ophthalmologic examination,Goldmann Applanation Tonometry,vital signs,physical examination, performance status,ECG,color fundus photographs,Fluorescein Angiograms,Optical Coherence Tomography,laboratory&pregnancy tests& concomitant medication were assessed at screening prior to Day1

    Period 1
    Period 1 title
    Year 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    It was the responsibility of the Principal Investigator to ensure that the physician assessing adverse events (AEs), the visual acuity (VA) examiner, all masked study personnel and the subject remain masked to the subject’s treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sham + Lucentis
    Arm description
    		 Subjects received the Lucentis injection first, followed by a Sham injection (pressure applied at the would-be injection site with a needle-less syringe hub).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sham + Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects received the Lucentis injection first (0.5 mg/eye), followed by a Sham injection (pressure applied at the would-be injection site with a needle-less syringe hub). Lucentis was administered as intravitreal injection and was administered once monthly (approximately every 28 days) in the first year of this study.

    Arm title
    		 Fovista + Lucentis
    Arm description
    		 Subjects received the Lucentis injection first, followed by Fovista injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fovista + Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects received the Lucentis injection first (0.5 mg/eye), followed by the Fovista injection (1.5 mg/eye). Both active study drugs were administered as intravitreal injections. Study drugs were administered once monthly (approximately every 28 days) in the first year of this study.

    Number of subjects in period 1 [1]
    		Sham + Lucentis Fovista + Lucentis
    Started
    315
    311
    Completed
    284
    282
    Not completed
    31
    29
         Consent withdrawn by subject
    15
    11
         Physician decision
    -
    4
         Adverse event, non-fatal
    15
    10
         Subject non-compliance
    1
    1
         Other
    -
    1
         Sponsor decision
    -
    1
         Lost to follow-up
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject in the Sham + Lucentis group was randomized but not treated. Therefore the number of subjects in the Sham + Lucentis group is 315.
    Period 2
    Period 2 title
    Year 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sham + Lucentis
    Arm description
    		 Subjects received the Lucentis injection first, followed by a “Sham” injection (pressure applied at the would-be injection site with a needle-less syringe hub) at Year 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sham + Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects received the Lucentis injection first (0.5 mg/eye), followed by a “Sham” injection (pressure applied at the would-be injection site with a needle-less syringe hub). Lucentis was administered as intravitreal injections and was administered once monthly (approximately every 28 days) in the first year of this study. During the second year, treatment was based on the stability of visual acuity, ophthalmic examination and imaging.

    Arm title
    		 Fovista + Lucentis
    Arm description
    		 Subjects received the Lucentis injection first, followed by Fovista injection (pressure applied at the would-be injection site with a needle-less syringe hub) at Year 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fovista + Lucentis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Subjects received the Lucentis injection first, followed by the Fovista injection (pressure applied at the would-be injection site with a needle-less syringe hub). Both active study drugs were administered as IVT injections. Study drugs were administered once monthly (approximately every 28 days) in the first year of this study. During the second year, treatment was based on the stability of visual acuity, ophthalmic examination and imaging.

    Number of subjects in period 2
    		Sham + Lucentis Fovista + Lucentis
    Started
    284
    282
    Completed
    188
    189
    Not completed
    96
    93
         Physician decision
    1
    2
         Consent withdrawn by subject
    12
    11
         Adverse event, non-fatal
    6
    11
         Subject non-compliance
    -
    1
         Sponsor decision
    75
    67
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sham + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by a Sham injection (pressure applied at the would-be injection site with a needle-less syringe hub).

    Reporting group title
    Fovista + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by Fovista injection.

    Reporting group values
    		 Sham + Lucentis Fovista + Lucentis Total
    Number of subjects
    		 315 311 626
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 31 30 61
        From 65-84 years
    		 221 224 445
        85 years and over
    		 63 57 120
    Age continuous
    Baseline characteristics were assessed on intent-to-treat population (ITT) population which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    Units: years
        arithmetic mean (standard deviation)
    		 76.8 ( 8.71 ) 76.9 ( 8.50 ) -
    Gender categorical
    Baseline characteristics were assessed on ITT population which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    Units: Subjects
        Female
    		 189 178 367
        Male
    		 126 133 259
    Iris colour
    Units: Subjects
        Light
    		 130 124 254
        Medium
    		 137 122 259
        Dark
    		 48 65 113
    Study eye
    Units: Subjects
        Right
    		 167 149 316
        Left
    		 148 162 310

    End points

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    End points reporting groups
    Reporting group title
    Sham + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by a Sham injection (pressure applied at the would-be injection site with a needle-less syringe hub).

    Reporting group title
    Fovista + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by Fovista injection.
    Reporting group title
    Sham + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by a “Sham” injection (pressure applied at the would-be injection site with a needle-less syringe hub) at Year 2.

    Reporting group title
    Fovista + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by Fovista injection (pressure applied at the would-be injection site with a needle-less syringe hub) at Year 2.

    Primary: Mean change in visual acuity (ETDRS letters) from Baseline to Month 12

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    End point title
    		 Mean change in visual acuity (ETDRS letters) from Baseline to Month 12
    End point description
    The primary efficacy endpoint was the mean change in VA (ETDRS letters) from Baseline to Month 12. All VA assessments were performed by the study refractionist/ophthalmologist. For analyses of the primary endpoint, a Model for Repeated Measures (MRM) was used to assess the differences between the treatment groups at the Month 12 visit. VA was assessed on the ITT population which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    End point type
    Primary
    End point timeframe
    Baseline to Month 12
    End point values
    		 Sham + Lucentis Fovista + Lucentis
    Number of subjects analysed
    315
    311
    Units: ETDRS letters
    least squares mean (standard error)
        MRM change from Baseline to Month 12
    10.36 ( 0.87 )
    9.91 ( 0.88 )
    Statistical analysis title
    		 Model for Repeated Measures analysis
    Statistical analysis description
    Model for Repeated Measures (MRM) adjusted for the cross-classification of baseline VA (>=47 letters vs < 47 letters) and lesion subtype (> 50% classic vs <= 50% classic), visit, treatment by visit interaction, and the interaction of visit and the Baseline VA/lesion subtype cross-classification.
    Comparison groups
    Sham + Lucentis v Fovista + Lucentis
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7059
    Method
    		 Model for Repeated Measures
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.75
         upper limit
    		 1.86

    Secondary: Gain of 20 or More ETDRS Letters from Baseline to Month 12

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    End point title
    		 Gain of 20 or More ETDRS Letters from Baseline to Month 12
    End point description
    A secondary endpoint was to assess the proportion of subjects gaining ≥ 20 ETDRS letters from Baseline to Month 12. All VA assessments were performed by the study refractionist/ophthalmologist. VA was assessed on the ITT population which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    End point type
    Secondary
    End point timeframe
    Baseline to Month 12
    End point values
    		 Sham + Lucentis Fovista + Lucentis
    Number of subjects analysed
    315
    311
    Units: Percentage of subjects
    number (not applicable)
        Yes
    24.1
    22.5
        No
    62.9
    67.2
        Missing
    13.0
    10.3
    No statistical analyses for this end point

    Secondary: Loss of 5 or More ETDRS Letters from Baseline to Month 12

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    End point title
    		 Loss of 5 or More ETDRS Letters from Baseline to Month 12
    End point description
    A secondary endpoint was to assess the proportion of subjects losing ≥ 5 ETDRS letters from Baseline to Month 12. All VA assessments were performed by the study refractionist/ophthalmologist. VA was assessed on the ITT population which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    End point type
    Secondary
    End point timeframe
    Baseline to Month 12
    End point values
    		 Sham + Lucentis Fovista + Lucentis
    Number of subjects analysed
    315
    311
    Units: Percentage of subjects
    number (not applicable)
        Yes
    10.2
    12.2
        No
    76.8
    77.5
        Missing
    13.0
    10.3
    No statistical analyses for this end point

    Secondary: Achievement of VA (ETDRS Snellen Equivalent) 20/25 or Better at Month 12

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    End point title
    		 Achievement of VA (ETDRS Snellen Equivalent) 20/25 or Better at Month 12
    End point description
    A secondary endpoint was to assess the proportion of subjects in each treatment group achieving VA of 20/25 or better at Month 12. All VA assessments were performed by the study refractionist/ophthalmologist. VA was assessed on the ITT population which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    End point type
    Secondary
    End point timeframe
    Baseline to Month 12
    End point values
    		 Sham + Lucentis Fovista + Lucentis
    Number of subjects analysed
    315
    311
    Units: Percentage of subjects
    number (not applicable)
        Yes
    14.6
    13.5
        No
    72.4
    76.2
        Missing
    13.0
    10.3
    No statistical analyses for this end point

    Secondary: Mean change in visual acuity (ETDRS letters) from baseline to Month 6

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    End point title
    		 Mean change in visual acuity (ETDRS letters) from baseline to Month 6
    End point description
    This analysis was conducted on the ITT which consisted of all randomized subjects who received at least one dose of study drug, irrespective of the dose actually received. Subjects were analyzed as per the dose group assigned at randomization. Subjects were included in a particular analysis, for a particular population, if relevant data were available for analysis (e.g., the primary analysis required one baseline and at least one post baseline VA measurement, to calculate a change score).
    End point type
    Secondary
    End point timeframe
    Baseline to Month 6
    End point values
    		 Sham + Lucentis Fovista + Lucentis
    Number of subjects analysed
    315
    311
    Units: ETDRS letters
        least squares mean (standard error)
    9.15 ( 0.75 )
    8.20 ( 0.77 )
    No statistical analyses for this end point

    Secondary: Growth of CNV Area from Baseline to Month 12 by Fluorescein Angiography

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    End point title
    		 Growth of CNV Area from Baseline to Month 12 by Fluorescein Angiography
    End point description
    A secondary endpoint was to assess the proportion of subjects with growth of Choroidal Neovascularization (CNV) area from Baseline to Month 12 by Fluorescein Angiography (FA). All FA images were centrally read. CNV Area is defined as Classic CNV Area + Occult CNV Area + Retinal Pigment Epithelium staining. Growth of CNV area is defined as a change greater than zero in the CNV area on FA from Baseline to Month 12. Baseline is the last non-missing measurement prior to the first dose of study drug. Subjects were analyzed as per the dose group assigned at randomization.
    End point type
    Secondary
    End point timeframe
    Baseline to Month 12.
    End point values
    		 Sham + Lucentis Fovista + Lucentis
    Number of subjects analysed
    315
    311
    Units: Percentage of subjects
    number (not applicable)
        Yes
    8.3
    8.7
        No
    75.6
    77.8
        Missing
    16.2
    13.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Randomization at Day 1 (14 days after Screening) until end of study.
    Adverse event reporting additional description
    AEs were reported on the safety population (all subjects who received at least 1dose of study drug [Fovista,Lucentis or Sham]). Subjects who had ever received an injection of Fovista were analyzed in the Fovista+Lucentis group. Causally related occurrences included both events reported as: related to injection procedure and related to study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Sham + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by a “Sham” injection (pressure applied at the would-be injection site with a needle-less syringe hub).

    Reporting group title
    Fovista + Lucentis
    Reporting group description
    		 Subjects received the Lucentis injection first, followed by Fovista injection.

    Serious adverse events
    		 Sham + Lucentis Fovista + Lucentis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    49 / 314 (15.61%)
    56 / 312 (17.95%)
         number of deaths (all causes)
    4
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III stage IV
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage I
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    3 / 314 (0.96%)
    2 / 312 (0.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung squamous cell carcinoma stage III
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to central nervous system
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to liver
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    2 / 314 (0.64%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma stage III
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 312 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Cataract traumatic
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 314 (0.64%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    3 / 314 (0.96%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 314 (0.32%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    3 / 314 (0.96%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 312 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Macular hole
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal pigment epithelial tear
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    2 / 314 (0.64%)
    6 / 312 (1.92%)
         occurrences causally related to treatment / all
    1 / 2
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Infectious colitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sham + Lucentis Fovista + Lucentis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    136 / 314 (43.31%)
    161 / 312 (51.60%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    25 / 314 (7.96%)
    49 / 312 (15.71%)
         occurrences all number
    42
    101
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    50 / 314 (15.92%)
    74 / 312 (23.72%)
         occurrences all number
    136
    166
    Punctate keratitis
         subjects affected / exposed
    40 / 314 (12.74%)
    35 / 312 (11.22%)
         occurrences all number
    97
    93
    Conjunctival hyperaemia
         subjects affected / exposed
    24 / 314 (7.64%)
    24 / 312 (7.69%)
         occurrences all number
    53
    48
    Eye pain
         subjects affected / exposed
    21 / 314 (6.69%)
    22 / 312 (7.05%)
         occurrences all number
    35
    51
    Vitreous floaters
         subjects affected / exposed
    12 / 314 (3.82%)
    22 / 312 (7.05%)
         occurrences all number
    13
    28
    Eye irritation
         subjects affected / exposed
    15 / 314 (4.78%)
    18 / 312 (5.77%)
         occurrences all number
    35
    34
    Keratitis
         subjects affected / exposed
    14 / 314 (4.46%)
    18 / 312 (5.77%)
         occurrences all number
    47
    64
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 314 (5.73%)
    17 / 312 (5.45%)
         occurrences all number
    20
    18
    Urinary tract infection
         subjects affected / exposed
    18 / 314 (5.73%)
    17 / 312 (5.45%)
         occurrences all number
    25
    23
    Bronchitis
         subjects affected / exposed
    11 / 314 (3.50%)
    16 / 312 (5.13%)
         occurrences all number
    12
    18

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2014
    1. Clarification of study drug retreatment algorithm. 2. Subject selection criteria were widened to include more subjects. 3. Previous or concomitant therapy was modified to clarify that therapy was prescribed at the investigator's discretion. 4. Clarification of when routine office procedures performed before informed consent may be used as screening procedures for this study. 5. Screening: clarification that Applanation Tonometry was Goldmann Applanation Tonometry. 6. Clarification that if a patient is randomized, the repeat OCT (and FA, if taken) must be submitted to the Reading Center to be used as the new study baseline. 7. A window of +/- 1 day was added to assessments. 8. Subfoveal choroidal neovascularization with some classic component (i.e., predominantly classic or minimally classic) secondary to AMD was changed to subfoveal choroidal neovascularization secondary to AMD. Subjects without evidence of a “classic” lesion on fluorescein angiogram, but with evidence of subretinal highly-reflective material on high resolution SD-OCT, were stratified into the ≤50% classic group at the time of stratification. 9. Analysis upon all Patients Completing Month 12 was amended to note that “topline” Month 12 results may need to be publically disseminated as per U.S. business law. 10. Clarification of the definition of the relationship of adverse events to study drug and injection procedure.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Feb 2017
    All of the subjects were terminated early from the study due to Sponsor decision, after analyses of the Year-1 data from Phase 3 studies OPH1002 and OPH1003 showed that the addition of Fovista to Lucentis did not lead to further visual improvements.
    -

    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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