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    Clinical Trial Results:
    A multi center, single arm, interventional Phase 4 study to evaluate a Treat and Extend regimen of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion

    Summary
    EudraCT number
    		 2014-003193-17
    Trial protocol
    		 DE   GB   DK   FR   IT  
    Global end of trial date
    31 Jul 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Sep 2020
    First version publication date
    05 Jul 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Update of results

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-5321/17514
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02800642
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    31 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy and durability (treatment interval) of 2 mg intravitreal (IVT) aflibercept in a Treat and Extend (T&E) regimen over a treatment period of 76 weeks using protocol defined visual and anatomic criteria in subjects with macular edema secondary to CRVO
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 49
    Worldwide total number of subjects
    162
    EEA total number of subjects
    126
    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)
    62
    From 65 to 84 years
    89
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 244 subjects were screened in 42 study centers in 8 countries, the first subject first visit was on 10/Jun/2016 and last subject last visit was on 31/Jun/2019

    Pre-assignment
    Screening details
    		 Of the 244 screened subjects, 162 subjects completed screening and entered the treatment period

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IVT aflibercept
    Arm description
    		 Subjects with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aflibercept
    Investigational medicinal product code
    BAY86-5321
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The recommended dose for intravitreal aflibercept is 2 mg equivalent to 50 microliter. Study treatment will be administered at baseline and at monthly intervals until stabilization of disease. When stability is achieved, the treatment interval can be extended based on visual and anatomic outcomes as judged by the treating investigator

    Number of subjects in period 1
    		IVT aflibercept
    Started
    162
    Completed
    137
    Not completed
    25
         Consent withdrawn by subject
    3
         Physician decision
    2
         Death
    3
         Other
    10
         Adverse event
    6
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IVT aflibercept
    Reporting group description
    		 Subjects with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks

    Reporting group values
    		 IVT aflibercept Total
    Number of subjects
    		 162 162
    Age categorical
    Units: Subjects
        18-64 years
    		 62 62
        65-84 years
    		 89 89
        >= 85 years
    		 11 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.4 ( 13.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 65
        Male
    		 97 97
    Race
    Units: Subjects
        White
    		 154 154
        Black
    		 1 1
        Asian
    		 3 3
        Not reported
    		 4 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 156 156
        Not reported
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    IVT aflibercept
    Reporting group description
    		 Subjects with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF included all subjects who received any study drug

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all enrolled subjects who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment. With regard to the efficacy evaluation of this study, the FAS was considered the primary analysis

    Primary: The percentage of subjects who gain ≥ 15 letters in best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy score (ETDRS) chart compared to baseline

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    End point title
    		 The percentage of subjects who gain ≥ 15 letters in best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy score (ETDRS) chart compared to baseline [1]
    End point description
    Subjects who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity
    End point type
    Primary
    End point timeframe
    Baseline and Week 76
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis was provided in the Attachment
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: percent
        number (confidence interval 95%)
    65.6 (57.7 to 72.9)
    Attachments
    		 Statistical analysis
    No statistical analyses for this end point

    Primary: The percentage of subjects with a mean treatment interval between injections of ≥ 8 weeks

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    End point title
    		 The percentage of subjects with a mean treatment interval between injections of ≥ 8 weeks [2]
    End point description
    Subjects who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
    End point type
    Primary
    End point timeframe
    From the last actual visit of the initiation phase to Week 76
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis was provided in the Attachment
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: percent
        number (confidence interval 95%)
    45.0 (37.1 to 53.1)
    Attachments
    		 Statistical analysis
    No statistical analyses for this end point

    Secondary: The change in best corrected visual acuity (BCVA) as measured by the early treatment diabetic retinopathy (ETDR) letter score from baseline

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    End point title
    		 The change in best corrected visual acuity (BCVA) as measured by the early treatment diabetic retinopathy (ETDR) letter score from baseline
    End point description
    The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24, 52, and 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: scores
    arithmetic mean (standard deviation)
        Absolute BCVA letter score at baseline
    51.9 ( 16.8 )
        Absolute BCVA letter score at Week 24
    72.4 ( 16.6 )
        Absolute BCVA letter score at Week 52
    71.8 ( 18.1 )
        Absolute BCVA letter score at Week 76
    72.3 ( 18.5 )
        Change from baseline at Week 24
    20.4 ( 17.0 )
        Change from baseline at Week 52
    19.9 ( 19.1 )
        Change from baseline at Week 76
    20.3 ( 19.5 )
    No statistical analyses for this end point

    Secondary: The change in central retinal thickness (CRT) from baseline

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    End point title
    		 The change in central retinal thickness (CRT) from baseline
    End point description
    CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT)
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24, 52 and 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    158
    Units: micrometer
    arithmetic mean (standard deviation)
        Absolute CRT at baseline
    759.9 ( 246.0 )
        Absolute CRT at Week 24
    271.2 ( 53.1 )
        Absolute CRT at Week 52
    279.8 ( 106.8 )
        Absolute CRT at Week 76
    265.4 ( 57.9 )
        Change from baseline at Week 24
    -488.9 ( 254.6 )
        Change from baseline at Week 52
    -481.3 ( 266.5 )
        Change from baseline at Week 76
    -496.1 ( 252.4 )
    No statistical analyses for this end point

    Secondary: The number of injections per subject

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    End point title
    		 The number of injections per subject
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: injections
        arithmetic mean (standard deviation)
    12.2 ( 2.53 )
    No statistical analyses for this end point

    Secondary: The mean treatment interval between injections

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    End point title
    		 The mean treatment interval between injections
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    150
    Units: weeks
        arithmetic mean (standard deviation)
    6.37 ( 1.150 )
    No statistical analyses for this end point

    Secondary: The percentage of subjects who gain ≥ 15 letters in best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy score (ETDRS) chart compared to baseline

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    End point title
    		 The percentage of subjects who gain ≥ 15 letters in best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy score (ETDRS) chart compared to baseline
    End point description
    The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24, Week 52
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: percent
    number (confidence interval 95%)
        Week 24
    68.8 (61.0 to 75.8)
        Week 52
    68.1 (60.3 to 75.3)
    No statistical analyses for this end point

    Secondary: The percentage of subjects with change in retinal non-perfusion (FA/FP) status from baseline

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    End point title
    		 The percentage of subjects with change in retinal non-perfusion (FA/FP) status from baseline
    End point description
    The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, <10 ischemic disc area, >=10 ischemic disc area and missing status
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24, 52 and 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: percent
    number (not applicable)
        Baseline to week 24: no to <10
    4.4
        Baseline to week 24: no to >=10
    3.8
        Baseline to week 24: no to missing
    6.3
        Baseline to week 24: <10 to no
    0.6
        Baseline to week 24: <10 to >=10
    0
        Baseline to week 24: <10 to missing
    0
        Baseline to week 24: >=10 to no
    1.3
        Baseline to week 24: >=10 to <10
    0
        Baseline to week 24: >=10 to missing
    0.6
        Baseline to week 24: missing to no
    0
        Baseline to week 24: missing to <10
    0.6
        Baseline to week 24: missing to >=10
    0.6
        Baseline to week 24: no status change
    81.9
        Baseline to week 52: no to <10
    5.0
        Baseline to week 52: no to >=10
    5.6
        Baseline to week 52: no to missing
    10.6
        Baseline to week 52: <10 to no
    1.9
        Baseline to week 52: <10 to >=10
    0
        Baseline to week 52: <10 to missing
    0
        Baseline to week 52: >=10 to no
    1.9
        Baseline to week 52: >=10 to <10
    0
        Baseline to week 52: >=10 to missing
    0
        Baseline to week 52: missing to no
    0
        Baseline to week 52: missing to <10
    0.6
        Baseline to week 52: missing to >=10
    0.6
        Baseline to week 52: no status change
    73.8
        Baseline to week 76: no to <10
    3.1
        Baseline to week 76: no to >=10
    4.4
        Baseline to week 76: no to missing
    18.1
        Baseline to week 76: <10 to no
    1.3
        Baseline to week 76: <10 to >=10
    0.6
        Baseline to week 76: <10 to missing
    0.6
        Baseline to week 76: >=10 to no
    0.6
        Baseline to week 76: >=10 to <10
    0
        Baseline to week 76: missing to no
    0
        Baseline to week 76: missing to <10
    0.6
        Baseline to week 76: missing to >=10
    0.6
        Baseline to week 76: no status change
    69.4
        Baseline to week 76: >=10 to missing
    0.6
    No statistical analyses for this end point

    Secondary: The percentage of subjects with absence of subretinal fluid

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    End point title
    		 The percentage of subjects with absence of subretinal fluid
    End point description
    n is the number of subjects analyzed for each respective endpoint
    End point type
    Secondary
    End point timeframe
    Baseline, week 24, week 52 and week 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    160
    Units: percent
    number (confidence interval 95%)
        Baseline (n=160)
    25.6 (19.1 to 33.1)
        Week 24 (n=154)
    98.7 (95.4 to 99.8)
        Week 52 (n=153)
    95.4 (90.8 to 98.1)
        Week 76 (n=137)
    97.8 (93.7 to 99.5)
    No statistical analyses for this end point

    Secondary: The number of participants with treatment-emergent adverse events (TEAE) categorized by severity and with any ocular TEAE

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    End point title
    		 The number of participants with treatment-emergent adverse events (TEAE) categorized by severity and with any ocular TEAE
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 30 days after week 76
    End point values
    		 IVT aflibercept
    Number of subjects analysed
    162
    Units: subjects
        Any ocular TEAEs
    98
        Any mild TEAE
    41
        Any moderate TEAE
    70
        Any severe TEAE
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days after week 76
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    IVT aflibercept
    Reporting group description
    		 Subjects with macular edema secondary to CRVO were treated with 2 mg study drug intravitrealaflibercept over a treatment period of 76 weeks.

    Serious adverse events
    		 IVT aflibercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 162 (19.75%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    4 / 162 (2.47%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bundle branch block bilateral
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dementia
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cataract
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal ischaemia
         subjects affected / exposed
    2 / 162 (1.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    2 / 162 (1.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic haemorrhage
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Latent syphilis
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IVT aflibercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 162 (50.00%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    20 / 162 (12.35%)
         occurrences all number
    40
    Vascular disorders
    Hypertension
         subjects affected / exposed
    19 / 162 (11.73%)
         occurrences all number
    25
    Eye disorders
    Macular oedema
         subjects affected / exposed
    12 / 162 (7.41%)
         occurrences all number
    13
    Conjunctival haemorrhage
         subjects affected / exposed
    18 / 162 (11.11%)
         occurrences all number
    23
    Vitreous detachment
         subjects affected / exposed
    9 / 162 (5.56%)
         occurrences all number
    11
    Retinal haemorrhage
         subjects affected / exposed
    14 / 162 (8.64%)
         occurrences all number
    14
    Retinal ischaemia
         subjects affected / exposed
    13 / 162 (8.02%)
         occurrences all number
    16
    Visual acuity reduced
         subjects affected / exposed
    26 / 162 (16.05%)
         occurrences all number
    37
    Foreign body sensation in eyes
         subjects affected / exposed
    9 / 162 (5.56%)
         occurrences all number
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    26 / 162 (16.05%)
         occurrences all number
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2016
    Clarification that the secondary and exploratory variables of retinal perfusion status included data from screening/baseline combined visit; Clarification on time point for follow up and the final study visit; Eligibility criteria did not need to be repeated at the baseline visit; Definition of types of age related macular degeneration (Exclusion criterion 22); Clarification on time period for stability criteria; Clarification that PRP rescue may be used per investigator discretion; Pregnancy testing was mandatory for women of childbearing potential at every treatment visit prior to injection and at end of study visit if required by local regulations.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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