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    Clinical Trial Results:
    Clinical efficacy and mechanistic evaluation of Eplerenone for Central serous chorio-retinopathy – the VICI randomised trial.

    Summary
    EudraCT number
    		 2016-000113-70
    Trial protocol
    		 GB  
    Global end of trial date
    03 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2020
    First version publication date
    12 Jul 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NA
    Additional study identifiers
    ISRCTN number
    		 ISRCTN92746680
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Southampton NHS Foundation Trust
    Sponsor organisation address
    SGH - Level E, Laboratory and Pathology Block, SCBR - MP 138, Southampton, United Kingdom, SO16 6YD
    Public contact
    CTEU Bristol, CTEU Bristol, 0117 342 2374, vici-trial@bristol.ac.uk
    Scientific contact
    CTEU Bristol, CTEU Bristol, 0117 342 2374, vici-trial@bristol.ac.uk
    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 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether vision following eplerenone therapy alongside usual care is superior to placebo with usual care in eyes with chronic Central serous chorio-retinopathy.
    Protection of trial subjects
    All potential participants were sent or given an invitation letter and patient information sheet (PIS) (approved by the local Research Ethics Committee,(REC)) describing the study. The patient had time to read the PIS and to discuss their participation with others outside the research team (e.g. relatives or friends) if they wished. Full informed consent was obtained for every trial participant. The patient's GP was informed of their participation in the trial. All members of the direct healthcare team are contractually bound to abide by standard NHS conditions of confidentiality and the need to access medical records will be explained to each patient during the process of obtaining consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2016
    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
    United Kingdom: 114
    Worldwide total number of subjects
    114
    EEA total number of subjects
    114
    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)
    114
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of the 223 patients initially eligible, 114 gave written informed consent and were randomised.

    Pre-assignment
    Screening details
    		 Between December 2016 and February 2018, 402 patients were screened. During the initial eligibility screening stage 97 patients were found to be ineligible. Eighty-two initially eligible patients were not approached for consent. Of patients who were eligible and given a PIL, 44 declined to consent.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Masking was implemented by over-encapsulation of the eplerenone/placebo to produce identical capsules. Capsules were supplied in bottles with identical labelling except for a unique bottle number. Bottle numbers were assigned against an allocation list. Only personnel at the manufacturing pharmacy and the trial database manager had access to the allocation list for the purposes of producing and managing the IMP.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo with usual care
    Arm description
    		 Placebo tablet, manufactured to match the Eplerenone tablets, with usual care.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Same regimen as for intervention

    Arm title
    		 Eplerenone with usual care
    Arm description
    		 Eplerenone 25 mg/day increased to 50 mg/day after 1 week (as per manufacturer’s recommendations for dose initiation) in addition to usual care. Treatment will be continued until there is evidence of complete resolution of sub-retinal fluid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eplerenone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplerenone 25 mg/day increased to 50 mg/day after 1 week (as per manufacturer’s recommendations for dose initiation) in addition to usual care. Treatment will be continued until there is evidence of complete resolution of SRF. The 25mg and 50mg doses will be achieved using 25mg and 50mg strength tablets respectively.

    Number of subjects in period 1
    		Placebo with usual care Eplerenone with usual care
    Started
    57
    57
    Completed
    57
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo with usual care
    Reporting group description
    		 Placebo tablet, manufactured to match the Eplerenone tablets, with usual care.

    Reporting group title
    Eplerenone with usual care
    Reporting group description
    		 Eplerenone 25 mg/day increased to 50 mg/day after 1 week (as per manufacturer’s recommendations for dose initiation) in addition to usual care. Treatment will be continued until there is evidence of complete resolution of sub-retinal fluid.

    Reporting group values
    		 Placebo with usual care Eplerenone with usual care Total
    Number of subjects
    		 57 57 114
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.9 ( 7.9 ) 47.4 ( 7.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 15 29
        Male
    		 43 42 85
    Ethnicity
    Units: Subjects
        White
    		 53 46 99
        Asian
    		 4 9 13
        Mixed
    		 0 1 1
        Other
    		 0 1 1
    Smoking
    Units: Subjects
        Current
    		 10 12 22
        Ex
    		 16 25 41
        Never
    		 31 20 51
    Heart failure
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    Myocardial infarction
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 56 57 113
    History of angina
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    CCS class
    Units: Subjects
        No angina
    		 57 57 114
    NYHA class
    Units: Subjects
        Class 0
    		 56 57 113
        Class I
    		 1 0 1
    Transient ischemic attack
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    Stroke
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 56 57 113
    DVT
    Units: Subjects
        Yes
    		 0 1 1
        No
    		 57 56 113
    PE
    Units: Subjects
        Yes
    		 0 1 1
        No
    		 57 56 113
    Claudication
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    Diabetes
    Units: Subjects
        None
    		 55 54 109
        Oral
    		 1 2 3
        Non-insulin injections
    		 1 1 2
    BCVA score
    Units: Subjects
        Low (54-67)
    		 7 7 14
        High (68-85)
    		 50 50 100
    Family history of CSCR
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 56 57 113
    Pupils abnormal
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    Cornea abnormal
    Units: Subjects
        Yes
    		 3 0 3
        No
    		 54 57 111
    Anterior chamber cells present
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    Anterior chamber flare present
    Units: Subjects
        Yes
    		 0 1 1
        No
    		 57 56 113
    Lens status
    Units: Subjects
        Phakic
    		 57 55 112
        Pseudophakic
    		 0 2 2
    Nuclear sclerosis (NUC)
    Units: Subjects
        Grade NUC-0
    		 47 51 98
        Grade NUC-1
    		 9 4 13
        Grade NUC-2
    		 1 0 1
        Unrecorded
    		 0 2 2
    Cortical (COR)
    Units: Subjects
        Grade COR-0
    		 56 55 111
        Grade COR-1
    		 1 0 1
        Unrecorded
    		 0 2 2
    Central Optical Involvement (CEN)
    Units: Subjects
        Yes
    		 2 2 4
        No
    		 55 53 108
        Unrecorded
    		 0 2 2
    Posterior subcapsular (PSC)
    Units: Subjects
        Grade PSC-0
    		 57 55 112
        Unrecorded
    		 0 2 2
    Disc abnormal
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 57 57 114
    Cataract surgery
    Units: Subjects
        Yes
    		 0 2 2
        No
    		 57 55 112
    Macular atrophy of RPE
    Units: Subjects
        Yes
    		 3 2 5
        No
    		 52 54 106
        Unrecorded
    		 2 1 3
    Systolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 132 (125 to 146) 129 (121 to 141) -
    Diastolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 80 (75 to 88) 80 (72.5 to 88.5) -
    Heart rate
    Units: bpm
        median (inter-quartile range (Q1-Q3))
    		 68 (60 to 76) 73 (66 to 80) -
    TSH/thyrotropin
    Units: mlU/L
        median (inter-quartile range (Q1-Q3))
    		 2 (1.1 to 2.2) 2 (1.2 to 2.2) -
    Thyroxine
    Units: pmol/L
        median (inter-quartile range (Q1-Q3))
    		 14 (13 to 17) 14 (13 to 16) -
    Triiodothyronine
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    		 4.5 (4.4 to 4.8) 4.6 (4.3 to 4.8) -
    HbA1c
    Units: mmol/mol
        median (inter-quartile range (Q1-Q3))
    		 35 (33.5 to 37) 36 (33 to 39) -
    Haematocrit (Hct)
    Units: L/L
        arithmetic mean (standard deviation)
    		 0.4 ( 0.0 ) 0.4 ( 0.0 ) -
    Platelets
    Units: x10^9/L
        median (inter-quartile range (Q1-Q3))
    		 250 (222.5 to 287.5) 259 (221 to 290) -
    WBC
    Units: x10^9/L
        median (inter-quartile range (Q1-Q3))
    		 7 (5 to 8) 7 (5.6 to 7.7) -
    Serum creatinine
    Units: μmol/L
        arithmetic mean (standard deviation)
    		 78 ( 14.9 ) 79 ( 13.2 ) -
    Urea
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 5 ( 1.2 ) 5 ( 1.2 ) -
    Potassium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 4 ( 0.3 ) 4 ( 0.4 ) -
    Sodium
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 140 (139 to 141) 141 (139 to 142) -
    Chloride
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 102 ( 2.7 ) 102 ( 2.6 ) -
    Bicarbonate
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 27 ( 3.3 ) 25 ( 2.2 ) -
    eGFR
    Units: ml/min
        median (inter-quartile range (Q1-Q3))
    		 82 (60 to 90) 84 (71 to 90) -
    Bilirubin
    Units: μmol/L
        median (inter-quartile range (Q1-Q3))
    		 8 (7 to 12) 8 (6 to 11) -
    ALT
    Units: units/L
        median (inter-quartile range (Q1-Q3))
    		 22 (19 to 29) 28 (21 to 39) -
    Albumin
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    		 45 (41 to 47) 45 (41 to 47) -
    Protein
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    		 73 (70 to 76) 72 (69 to 76) -
    CSCR duration
    Units: Months
        median (inter-quartile range (Q1-Q3))
    		 9 (6 to 18) 8 (6 to 22) -
    IOP measurement
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 15 (14 to 18) 15 (13 to 17) -
    Cup disc ratio
    Units: Ratio
        median (inter-quartile range (Q1-Q3))
    		 0.3 (0.2 to 0.3) 0.3 (0.2 to 0.3) -
    BCVA
    Units: EDTRS letters read
        median (inter-quartile range (Q1-Q3))
    		 78 (73 to 82) 77 (73 to 80) -
    Low luminance VA
    Units: ETDRS letters read
        median (inter-quartile range (Q1-Q3))
    		 64 (57 to 67) 57 (50 to 64) -
    Choroidal thickness
    Units: μm
        median (inter-quartile range (Q1-Q3))
    		 461 (381.5 to 534.5) 447 (398 to 509) -
    SRFT
    Units: μm
        median (inter-quartile range (Q1-Q3))
    		 119 (88 to 178) 147 (93 to 196) -
    Central subfield retinal thickness
    Units: μm
        median (inter-quartile range (Q1-Q3))
    		 322 (280 to 394) 360 (290 to 406) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo with usual care
    Reporting group description
    		 Placebo tablet, manufactured to match the Eplerenone tablets, with usual care.

    Reporting group title
    Eplerenone with usual care
    Reporting group description
    		 Eplerenone 25 mg/day increased to 50 mg/day after 1 week (as per manufacturer’s recommendations for dose initiation) in addition to usual care. Treatment will be continued until there is evidence of complete resolution of sub-retinal fluid.

    Primary: BCVA at 12 months

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    End point title
    		 BCVA at 12 months
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: ETDRS letters read
    median (inter-quartile range (Q1-Q3))
        Baseline
    78 (73 to 82)
    77 (73 to 80)
        4 weeks
    80 (73 to 84)
    79 (75 to 83)
        3 months
    80 (74 to 85)
    79 (76 to 83.5)
        6 months
    81 (74 to 86)
    80 (74 to 84)
        9 months
    81 (74.5 to 86.5)
    80 (74 to 85)
        12 months
    82 (74 to 87)
    81 (77 to 85)
    Statistical analysis title
    		 BCVA
    Comparison groups
    Eplerenone with usual care v Placebo with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.236
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 4.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.45

    Secondary: Low luminance VA at 12 months

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    End point title
    		 Low luminance VA at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: ETDRS letters read
    median (inter-quartile range (Q1-Q3))
        Baseline
    64 (57 to 67)
    57 (50 to 64)
        4 weeks
    63 (55 to 67)
    63 (54 to 67.5)
        3 months
    62 (58 to 69)
    63 (57 to 68)
        6 months
    66 (59 to 71)
    62 (56 to 71.5)
        9 months
    65 (59.5 to 73)
    65 (58 to 70)
        12 months
    65 (60 to 75)
    66 (57 to 71)
    Statistical analysis title
    		 Low luminance VA at 12 months
    Comparison groups
    Eplerenone with usual care v Placebo with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.785
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.79
         upper limit
    		 5.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.25

    Secondary: Central subfield retinal thickness (CSRT) at 12 months

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    End point title
    		 Central subfield retinal thickness (CSRT) at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months post-randomisation
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: µm
    median (inter-quartile range (Q1-Q3))
        Baseline
    322 (280 to 394)
    360 (290 to 406)
        4 weeks
    330 (272 to 386)
    328 (248.5 to 393.5)
        3 months
    285 (250 to 341)
    295 (240.5 to 383)
        6 months
    270 (247 to 313)
    290 (226 to 366)
        9 months
    268 (230 to 322)
    273 (220 to 366)
        12 months
    253 (232 to 303)
    272 (229 to 368)
    Statistical analysis title
    		 CSRT at 12 months
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.142
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.86
         upper limit
    		 56.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    16.44

    Secondary: Sub-retinal fluid thickness (SRFT) at 12 months

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    End point title
    		 Sub-retinal fluid thickness (SRFT) at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: µm
    median (inter-quartile range (Q1-Q3))
        Baseline
    119 (88 to 178)
    147 (93 to 196)
        12 months
    61 (0 to 111)
    89 (23 to 196)
    Statistical analysis title
    		 SRFT at 12 months
    Statistical analysis description
    Multiple imputation used to account for missing data.
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    48.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.43
         upper limit
    		 82.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.68

    Secondary: Macular atrophy of the RPE at 12 months

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    End point title
    		 Macular atrophy of the RPE at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    53
    49
    Units: Subjects
        Yes
    3
    4
        No
    50
    45
    No statistical analyses for this end point

    Secondary: Area change in macular RPE hypoautofluorescence at 12 months

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    End point title
    		 Area change in macular RPE hypoautofluorescence at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    3
    5
    Units: μm
        median (inter-quartile range (Q1-Q3))
    0.03 (0.03 to 0.04)
    0.72 (-0.73 to 2.1)
    No statistical analyses for this end point

    Secondary: Choroidal thickness at 12 months

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    End point title
    		 Choroidal thickness at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: μm
    median (inter-quartile range (Q1-Q3))
        Baseline
    460.5 (381.5 to 534.5)
    447 (398 to 509)
        12 months
    444 (375 to 524)
    495.5 (423 to 534)
    Statistical analysis title
    		 Choroidal thickness at 12 months
    Statistical analysis description
    Multiple imputation used to account for missing data
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    38.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.31
         upper limit
    		 64.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    13.38

    Secondary: Reduced choroidal permeability at 12 months

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    End point title
    		 Reduced choroidal permeability at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    54
    49
    Units: Subjects
        Yes
    3
    1
        No
    51
    48
    No statistical analyses for this end point

    Secondary: VFQ-25 overall composite score at 12 months

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    End point title
    		 VFQ-25 overall composite score at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    87 (80.3 to 91.3)
    89 (81.2 to 92)
        12 months
    92 (86.1 to 94.6)
    89 (83.7 to 93.3)
    Statistical analysis title
    		 VFQ-25 overall composite score at 12 months
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.127
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.45
         upper limit
    		 0.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.56
    Notes
    [1] - Multiple imputation used to account for missing data

    Secondary: Time to resolution of SRF

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    End point title
    		 Time to resolution of SRF
    End point description
    End point type
    Secondary
    End point timeframe
    12 month follow-up period
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Days
        median (confidence interval 95%)
    458.2 (214.1 to 702.3)
    603.3 (313.1 to 893.5)
    Statistical analysis title
    		 Time to complete resolution of SRF
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.463
    Method
    		 Interval-censored regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: Time to complete or partial resolution

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    End point title
    		 Time to complete or partial resolution
    End point description
    End point type
    Secondary
    End point timeframe
    12 month follow-up period
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: days
        median (confidence interval 95%)
    184.2 (122.3 to 246)
    141.1 (57.9 to 224.4)
    Statistical analysis title
    		 Time to complete or partial resolution of SRF
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.418
    Method
    		 Interval-censored regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31

    Secondary: Time to recurrence of SRF

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    End point title
    		 Time to recurrence of SRF
    End point description
    End point type
    Secondary
    End point timeframe
    12 month follow-up period
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    21
    21
    Units: days
        median (confidence interval 95%)
    192.1 (136.6 to 247.6)
    182.5 (117.7 to 247.3)
    Statistical analysis title
    		 Time to recurrence of SRF
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.836
    Method
    		 Interval-censored regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 2.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.48

    Secondary: New CSCR in fellow eye

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    End point title
    		 New CSCR in fellow eye
    End point description
    End point type
    Secondary
    End point timeframe
    12 month follow-up period
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Subjects
        Yes
    4
    5
        No
    53
    52
    No statistical analyses for this end point

    Secondary: Any CSCR in fellow eye

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    End point title
    		 Any CSCR in fellow eye
    End point description
    End point type
    Secondary
    End point timeframe
    12 month follow-up period
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Subjects
        Yes
    8
    8
        No
    49
    49
    No statistical analyses for this end point

    Secondary: Response (complete or partial)

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    End point title
    		 Response (complete or partial)
    End point description
    End point type
    Secondary
    End point timeframe
    12 month follow-up period
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    54
    52
    Units: Subjects
        3 months
    19
    25
        6 months
    27
    33
        12 months
    38
    38
        Never
    16
    14
    No statistical analyses for this end point

    Secondary: VFQ-25 near vision

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    End point title
    		 VFQ-25 near vision
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    75 (66.7 to 83.3)
    83 (66.7 to 91.7)
        12 months
    83 (75 to 100)
    83 (66.7 to 91.7)
    No statistical analyses for this end point

    Secondary: VFQ-25 distance vision

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    End point title
    		 VFQ-25 distance vision
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    92 (83.3 to 100.0)
    100 (83.3 to 100)
        12 months
    92 (83.3 to 100)
    100 (83.3 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 general health

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    End point title
    		 VFQ-25 general health
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    75 (50 to 75)
    75 (50 to 75)
        12 months
    75 (50 to 75)
    75 (50 to 75)
    No statistical analyses for this end point

    Secondary: VFQ-25 general vision

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    End point title
    		 VFQ-25 general vision
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    70 (60 to 80)
    60 (60 to 80)
        12 months
    80 (60 to 80)
    80 (60 to 80)
    No statistical analyses for this end point

    Secondary: VFQ-25 driving

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    End point title
    		 VFQ-25 driving
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    54
    54
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    92 (83.3 to 100)
    92 (83.3 to 100)
        12 months
    92 (83.3 to 100)
    92 (83.3 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 peripheral vision

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    End point title
    		 VFQ-25 peripheral vision
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    100 (75 to 100)
    100 (75 to 100)
        12 months
    100 (100 to 100)
    100 (75 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 colour vision

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    End point title
    		 VFQ-25 colour vision
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    100 (100 to 100)
    100 (100 to 100)
        12 months
    100 (100 to 100)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 ocular pain

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    End point title
    		 VFQ-25 ocular pain
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    88 (75 to 100)
    100 (75 to 100)
        12 months
    100 (75 to 100)
    100 (75 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 role difficulties

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    End point title
    		 VFQ-25 role difficulties
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    88 (75 to 100)
    88 (62.5 to 100)
        12 months
    100 (75 to 100)
    88 (62.5 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 dependency

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    End point title
    		 VFQ-25 dependency
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    100 (91.7 to 100)
    100 (91.7 to 100)
        12 months
    100 (100 to 100)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 social functioning

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    End point title
    		 VFQ-25 social functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    100 (100 to 100)
    100 (100 to 100)
        12 months
    100 (100 to 100)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: VFQ-25 mental health

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    End point title
    		 VFQ-25 mental health
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Score
    median (inter-quartile range (Q1-Q3))
        Baseline
    75 (56.3 to 87.5)
    75 (62.5 to 87.5)
        12 months
    88 (75 to 93.8)
    81 (75 to 87.5)
    No statistical analyses for this end point

    Secondary: Resolution of SRF and classification

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    End point title
    		 Resolution of SRF and classification
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks, 3 months, 6 months, 9 months and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    54
    56
    Units: Subjects
        4 weeks - complete resolution
    2
    4
        4 weeks - partial resolution
    4
    8
        4 weeks - non-responder
    48
    44
        3 months - complete resolution
    6
    5
        3 months - partial resolution
    12
    15
        3 months - non-responder
    36
    32
        6 months - complete resolution
    11
    8
        6 months - partial resolution
    10
    16
        6 months - non-responder
    33
    28
        9 months - complete resolution
    13
    9
        9 months - partial resolution
    10
    14
        9 months - non-responder
    29
    28
        12 months - complete resolution
    16
    8
        12 months - partial resolution
    13
    14
        12 months - non-responder
    25
    29
    No statistical analyses for this end point

    Secondary: Study eye FFA phenotype

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    End point title
    		 Study eye FFA phenotype
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    57
    57
    Units: Subjects
        Baseline - smoke stack
    1
    4
        Baseline - ink-blot
    37
    35
        Baseline - chronic epitheliopathy
    19
    18
        12 months - smoke stack
    2
    0
        12 months - ink-blot
    17
    26
        12 months - chronic epitheliopathy
    27
    15
        12 months - no early or late leakage visible
    8
    9
    No statistical analyses for this end point

    Post-hoc: Choroidal thickness in fellow eye

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    End point title
    		 Choroidal thickness in fellow eye
    End point description
    End point type
    Post-hoc
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo with usual care Eplerenone with usual care
    Number of subjects analysed
    50
    54
    Units: μm
    median (inter-quartile range (Q1-Q3))
        Baseline
    429 (365.5 to 486)
    386 (328 to 477)
        12 months
    466 (416 to 554)
    475 (390 to 525)
    Statistical analysis title
    		 Choroidal thickness in fellow eye
    Comparison groups
    Placebo with usual care v Eplerenone with usual care
    Number of subjects included in analysis
    104
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.056
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    30.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 60.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    15.57
    Notes
    [2] - Multiple imputation used to account for missing data

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 months post-randomisation
    Adverse event reporting additional description
    All expected and unexpected adverse events reported using MedDRA dictionary. For all events, 'non-serious adverse events' includes ALL events (serious and non-serious). This is consistent with the trial publication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo with usual care
    Reporting group description
    		 Placebo tablet, manufactured to match the Eplerenone tablets, with usual care.

    Reporting group title
    Eplerenone with usual care
    Reporting group description
    		 Eplerenone 25 mg/day increased to 50 mg/day after 1 week (as per manufacturer’s recommendations for dose initiation) in addition to usual care. Treatment will be continued until there is evidence of complete resolution of sub-retinal fluid.

    Serious adverse events
    		 Placebo with usual care Eplerenone with usual care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Metabolic surgery
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (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
    Diverticulitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (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: 0%
    Non-serious adverse events
    		 Placebo with usual care Eplerenone with usual care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 57 (54.39%)
    30 / 57 (52.63%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Withdrawal hypertension
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Circumcision
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Hernia repair
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Metabolic surgery
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Tonsillectomy
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Chills
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 57 (5.26%)
         occurrences all number
    2
    3
    Oropharyngeal pain
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 57 (5.26%)
         occurrences all number
    1
    5
    Palpitations
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 57 (7.02%)
         occurrences all number
    3
    4
    Headache
         subjects affected / exposed
    6 / 57 (10.53%)
    3 / 57 (5.26%)
         occurrences all number
    7
    5
    Burning sensation
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Eye disorders
    Decrease in visual acuity ≥15 letters (non-study eye)
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Incident choroidal neovascularisation (non-study eye)
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Blepharospasm (study eye)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Hordeolum (study eye)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Photosensitivity reaction (study eye)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Vision blurred (study eye)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Dry eye (non-study eye)
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Retinal tear (non-study eye)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Angle closure glaucoma (both eyes)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Blepharitis (both eyes)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Dry eye (both eyes)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Ocular hypertension (both eyes)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Visual impairment (both eyes)
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Eye contusion
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 57 (3.51%)
         occurrences all number
    3
    2
    Flatulence
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    5 / 57 (8.77%)
    4 / 57 (7.02%)
         occurrences all number
    7
    7
    Vomiting
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 57 (7.02%)
         occurrences all number
    0
    8
    Abdominal pain
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Tongue coated
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Alopecia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 57 (5.26%)
         occurrences all number
    3
    3
    Muscle spasms
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    5 / 57 (8.77%)
    7 / 57 (12.28%)
         occurrences all number
    5
    7
    Sjogren's syndrome
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Infection
         subjects affected / exposed
    3 / 57 (5.26%)
    8 / 57 (14.04%)
         occurrences all number
    4
    10
    Diverticulitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    8 / 57 (14.04%)
    8 / 57 (14.04%)
         occurrences all number
    8
    8
    Diabetes mellitus
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2016
    The trial schema and data collection table have been updated due to inconsistencies in the previous version of the protocol. Time frames for study visits have been added. Coordinating centre will also have code lists for unmasking. OCT images will only be graded by an independent reading centre at baseline and 12 months. Updated exclusion criteria, only patients receiving a combination of an ACE inhibitor and an ARB are excluded. The following exclusion criteria has been added due to guidance in the SmPC ‘Patients receiving high doses of Aspirin (>75mg).’ Randomisation must take place within one month of taking screening blood tests. Otherwise screening tests must be repeated
    05 Oct 2016
    Detail added to say that optometrists are allowed logs of previous refractions when carrying out visual function assessments. The following inclusion criterion has been added: ‘Investigator believes that there is sufficient evidence from patient history, case note documentation or appearance of the macula that CSCR has been present for at least 4 months.’ Patients with BCVA scores of up to 85 are now eligible for inclusion. Conconmittant medication list has been updated. Lists of primary and secondary outcomes have been edited. OCT A is to performed where equipment is available at screening and 12 months. Unmasking requires approval from CI/Co-Lead. Analyses section has been updated based on feedback from DMSC meeting.
    26 Jan 2017
    Correction to say that VICI is a phase 3 trial not a phase 2 trial Fundus photography has been added to the trial schema and data collection table. This procedure will be carried out twice (screening & 12 month follow up visit) and takes around 5 minutes. This had been omitted in error from previous versions of the protocol. We are not measuring fasting blood glucose. This had been removed from the trial schema before the protocol was submitted for approval but in error not removed from section 9.2 of the study protocol.
    20 Mar 2018
    Section 4.7. Updated minor text error in sample size justification. Sections 5.3, 6.2 and Table 1. Updated to include OCT-A at baseline or an interim time-point and at 12 months. Section 8.1. Updated reference safety information.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31982075
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