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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
    		 2013-002997-33
    Trial protocol
    		 GB   LV   AT   CZ   EE   SK   BE  
    Global end of trial date
    20 Feb 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 May 2018
    First version publication date
    23 Mar 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    The row for total of non-serious adverse events reported includes all subjects reporting non-serious adverse events. The row should include the total number of subjects who reported >= 5% non-serious adverse events only.

    Trial information

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    Trial identification
    Sponsor protocol code
    OPH1002
    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
    26 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    20 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 before undergoing any study-related procedure. 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
    28 Aug 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
    Poland: 46
    Country: Number of subjects enrolled
    Slovakia: 9
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    Austria: 10
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Czech Republic: 84
    Country: Number of subjects enrolled
    Estonia: 22
    Country: Number of subjects enrolled
    Italy: 118
    Country: Number of subjects enrolled
    Latvia: 46
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United States: 211
    Country: Number of subjects enrolled
    Brazil: 17
    Worldwide total number of subjects
    621
    EEA total number of subjects
    363
    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)
    47
    From 65 to 84 years
    477
    85 years and over
    97

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 122 centers in 13 countries between 28 August 2013 and 20 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 injections 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
    310
    309
    Completed
    282
    287
    Not completed
    28
    22
         Physician decision
    2
    2
         Consent withdrawn by subject
    17
    9
         Adverse event, non-fatal
    5
    10
         Subject non-compliance
    3
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    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: Overall, 311 subjects were randomized to the Fovista + Lucentis group. Of these 2 subjects did not receive treatment. Hence the total number of subjects in the Fovista + Lucentis group is 309.
    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
    Blinding implementation details
    It was the responsibility of the Principal Investigator to ensure that the physician assessing AEs, the 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 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.
    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. 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
    283
    286
    Completed
    156
    154
    Not completed
    127
    132
         Physician decision
    1
    -
         Consent withdrawn by subject
    9
    7
         Adverse event, non-fatal
    5
    6
         Subject non-compliance
    3
    1
         Sponsor decision
    104
    112
         Lost to follow-up
    5
    5
         Protocol deviation
    -
    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
    		 310 309 619
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 26 46
        From 65-84 years
    		 233 243 476
        85 years and over
    		 57 40 97
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 76.9 ( 8.04 ) 76.1 ( 7.98 ) -
    Gender categorical
    Units: Subjects
        Female
    		 196 181 377
        Male
    		 114 128 242
    Iris color
    Units: Subjects
        Light
    		 156 167 323
        Medium
    		 110 101 211
        Dark
    		 44 41 85
    Study eye
    Units: Subjects
        Right
    		 151 156 307
        Left
    		 159 153 312

    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).

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

    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
    310
    309
    Units: EDTRS letter
    least squares mean (standard error)
        MRM change from Baseline to Month 12
    9.82 ( 0.86 )
    10.74 ( 0.86 )
    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
    619
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4362
    Method
    		 Model for Repeated Measures
    Parameter type
    		 Difference in least squares means
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 3.23

    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
    310
    309
    Units: Percentage of subjects
    number (not applicable)
        Yes
    20.0
    25.9
        No
    68.7
    65.7
        Missing
    11.3
    8.4
    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
    310
    309
    Units: Percentage of subjects
    number (not applicable)
        Yes
    12.3
    12.0
        No
    76.5
    79.6
        Missing
    11.3
    8.4
    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
    310
    309
    Units: percentage of subjects
    number (not applicable)
        Yes
    13.2
    13.6
        No
    75.5
    78.0
        Missing
    11.3
    8.4
    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
    310
    309
    Units: Percentage of subjects
    number (not applicable)
        Yes
    7.4
    8.7
        No
    79.4
    79.9
        Missing
    13.2
    11.3
    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 have 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
    36 / 309 (11.65%)
    48 / 310 (15.48%)
         number of deaths (all causes)
    2
    6
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myxofibrosarcoma
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (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
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device malfunction
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 309 (0.00%)
    3 / 310 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 309 (0.00%)
    2 / 310 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 309 (0.32%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal anastomosis complication
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 309 (0.97%)
    3 / 310 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    1 / 309 (0.32%)
    2 / 310 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 309 (0.65%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angina unstable
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 309 (0.32%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac fibrillation
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 309 (0.00%)
    2 / 310 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    1 / 309 (0.32%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (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 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract subcapsular
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (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
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 309 (0.00%)
    3 / 310 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oroantral fistula
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 309 (0.32%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ureteric rupture
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (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
    Osteoarthritis
         subjects affected / exposed
    0 / 309 (0.00%)
    2 / 310 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone infarction
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (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
    Pneumonia
         subjects affected / exposed
    1 / 309 (0.32%)
    4 / 310 (1.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 309 (0.00%)
    3 / 310 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster meningoencephalitis
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia influenzal
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (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
    0 / 309 (0.00%)
    1 / 310 (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 bacterial
         subjects affected / exposed
    0 / 309 (0.00%)
    1 / 310 (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
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 309 (0.65%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 309 (0.65%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 309 (0.32%)
    0 / 310 (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
    114 / 309 (36.89%)
    123 / 310 (39.68%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    30 / 309 (9.71%)
    43 / 310 (13.87%)
         occurrences all number
    78
    157
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    56 / 309 (18.12%)
    60 / 310 (19.35%)
         occurrences all number
    177
    197
    Eye pain
         subjects affected / exposed
    26 / 309 (8.41%)
    23 / 310 (7.42%)
         occurrences all number
    47
    29
    Punctate keratitis
         subjects affected / exposed
    18 / 309 (5.83%)
    15 / 310 (4.84%)
         occurrences all number
    30
    22
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 309 (1.94%)
    19 / 310 (6.13%)
         occurrences all number
    6
    20

    More information

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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
    20 Feb 2017
    All of the subjects were terminated early from the study due to the 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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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