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    Clinical Trial Results:
    A randomized, double-masked, 48-week, parallel group, placebo-controlled, proof of concept study to investigate the efficacy and safety of RG7774 in patients with diabetes mellitus Type 1 or Type 2 with treatment naive diabetic retinopathy

    Summary
    EudraCT number
    		 2019-002067-10
    Trial protocol
    		 GB   SK   PL  
    Global end of trial date
    19 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Aug 2024
    First version publication date
    01 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BP41321
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04265261
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CANBERRA: BP41321
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4058
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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
    28 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision
    Protection of trial subjects
    All participants were required to sign an Informed Consent Form
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jun 2020
    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: 2
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    United States: 107
    Worldwide total number of subjects
    139
    EEA total number of subjects
    20
    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)
    109
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants with diabetes mellitus Type 1 or 2 with treatment-naive diabetic retinopathy

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received an oral dose of placebo matched to RG7774 once daily (QD)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received oral placebo once daily

    Arm title
    		 Vicasinabin 30 mg QD
    Arm description
    		 Participants received 30 mg of oral RG7774 QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vicasinabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 mg of oral vicasinabin once daily

    Arm title
    		 Vicasinabin 200 mg QD
    Arm description
    		 Participants received 200 mg of oral RG7774 QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vicasinabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 200 mg of oral vicasinabin once daily

    Number of subjects in period 1
    		Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD
    Started
    47
    48
    44
    Completed
    37
    43
    36
    Not completed
    10
    5
    8
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    2
    1
    4
         Physician decision
    -
    -
    1
         Non-Compliance with Study Drug
    1
    1
    -
         Adverse event, non-fatal
    2
    -
    -
         Protocol Deviation
    -
    2
    -
         Lost to follow-up
    4
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received an oral dose of placebo matched to RG7774 once daily (QD)

    Reporting group title
    Vicasinabin 30 mg QD
    Reporting group description
    		 Participants received 30 mg of oral RG7774 QD

    Reporting group title
    Vicasinabin 200 mg QD
    Reporting group description
    		 Participants received 200 mg of oral RG7774 QD

    Reporting group values
    		 Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD Total
    Number of subjects
    		 47 48 44 139
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 35 39 35 109
        From 65-84 years
    		 12 9 9 30
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.9 ( 9.3 ) 57.3 ( 10.0 ) 56.5 ( 10.5 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 17 18 16 51
        Male
    		 30 30 28 88
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 14 18 15 47
        Not Hispanic or Latino
    		 32 30 29 91
        Unknown or Not Reported
    		 1 0 0 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 2 3 7
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 5 0 4 9
        White
    		 40 46 35 121
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received an oral dose of placebo matched to RG7774 once daily (QD)

    Reporting group title
    Vicasinabin 30 mg QD
    Reporting group description
    		 Participants received 30 mg of oral RG7774 QD

    Reporting group title
    Vicasinabin 200 mg QD
    Reporting group description
    		 Participants received 200 mg of oral RG7774 QD

    Primary: Proportion of Participants with >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) from Baseline at Week 36 Measured in the Study Eye

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    End point title
    		 Proportion of Participants with >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) from Baseline at Week 36 Measured in the Study Eye
    End point description
    The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy)
    End point type
    Primary
    End point timeframe
    Week 36
    End point values
    		 Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD
    Number of subjects analysed
    38
    42
    35
    Units: Percentage
        number (confidence interval 95%)
    7.89 (2.72 to 20.8)
    9.52 (3.77 to 22.07)
    5.71 (1.58 to 18.61)
    Statistical analysis title
    		 Placebo vs Vicasinabin 30 mg
    Comparison groups
    Placebo v Vicasinabin 30 mg QD
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8586
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.86
         upper limit
    		 14.23
    Statistical analysis title
    		 Placebo vs Vicasinabin 200 mg
    Comparison groups
    Placebo v Vicasinabin 200 mg QD
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6388
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.18
         upper limit
    		 9.31

    Primary: Percentage of Participants with Adverse Events (AEs)

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    End point title
    		 Percentage of Participants with Adverse Events (AEs) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 1 year (baseline through follow-up period)
    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: There was no formal statistical analyses deemed necessary for this endpoint.
    End point values
    		 Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD
    Number of subjects analysed
    47
    48
    43
    Units: Percentage of participants
        number (not applicable)
    72.3
    64.6
    81.4
    No statistical analyses for this end point

    Secondary: Time-to-Event for Vision-Threatening DR in the Study Eye

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    End point title
    		 Time-to-Event for Vision-Threatening DR in the Study Eye
    End point description
    Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event. 9999 indicates that either the Kaplan-Meier percentile time has not been achieved or that the percentile is at a boundary of the observed range and no upper or lower 95% CI can be found.
    End point type
    Secondary
    End point timeframe
    Up to Day 277
    End point values
    		 Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD
    Number of subjects analysed
    47
    48
    43
    Units: Days
        number (confidence interval 95%)
    9999 (257.0 to 9999)
    267.0 (254.0 to 9999)
    9999 (260.0 to 9999)
    No statistical analyses for this end point

    Secondary: Incidence of new Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye

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    End point title
    		 Incidence of new Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye
    End point description
    This is a descriptive summary of the incidence of new ASNV, new PDR, and both new and pre-existing DME, all of which indicate disease progression.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD
    Number of subjects analysed
    47
    48
    43
    Units: Percentage of participants
    number (confidence interval 95%)
        New ASNV
    0 (0.0 to 9.4)
    0 (0.0 to 9.2)
    0 (0.0 to 10.2)
        New PDR
    0 (0.0 to 9.4)
    6.3 (1.6 to 18.2)
    0 (0.0 to 10.2)
        New DME
    0 (0.0 to 9.4)
    4.2 (0.7 to 15.4)
    0 (0.0 to 10.2)
        Pre-existing DME requiring treatment
    4.3 (0.7 to 15.7)
    10.4 (3.9 to 23.4)
    6.8 (1.8 to 20.1)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36

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    End point title
    		 Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
    End point description
    BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 36
    End point values
    		 Placebo Vicasinabin 30 mg QD Vicasinabin 200 mg QD
    Number of subjects analysed
    47
    48
    43
    Units: Number of letters
        arithmetic mean (standard error)
    0.12 ( 0.747 )
    -0.45 ( 0.697 )
    -0.22 ( 0.744 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 3 years
    Adverse event reporting additional description
    All-cause mortality includes the entire study population. SAE and NSAE reporting includes the safety population, which included all participants who gave informed consent and received at least one dose of study medication. Participants in the safety population were grouped according to the actual treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received an oral dose of placebo matched to RG7774 once daily (QD)

    Reporting group title
    Vicasinabin 200 mg QD
    Reporting group description
    		 Participants received 200 mg of oral RG7774 QD

    Reporting group title
    Vicasinabin 30 mg QD
    Reporting group description
    		 Participants received 30 mg of oral RG7774 QD

    Serious adverse events
    		 Placebo Vicasinabin 200 mg QD Vicasinabin 30 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 47 (17.02%)
    5 / 43 (11.63%)
    3 / 48 (6.25%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Intermittent claudication
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal tear
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Osteomyelitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 43 (2.33%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Vicasinabin 200 mg QD Vicasinabin 30 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 47 (27.66%)
    15 / 43 (34.88%)
    21 / 48 (43.75%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 43 (2.33%)
    3 / 48 (6.25%)
         occurrences all number
    2
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 43 (4.65%)
    2 / 48 (4.17%)
         occurrences all number
    5
    2
    2
    Eye disorders
    Diabetic retinal oedema
         subjects affected / exposed
    3 / 47 (6.38%)
    6 / 43 (13.95%)
    8 / 48 (16.67%)
         occurrences all number
    3
    7
    13
    Diabetic retinopathy
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 43 (2.33%)
    5 / 48 (10.42%)
         occurrences all number
    3
    2
    5
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 43 (4.65%)
    3 / 48 (6.25%)
         occurrences all number
    2
    3
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 43 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    4
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 47 (2.13%)
    5 / 43 (11.63%)
    3 / 48 (6.25%)
         occurrences all number
    1
    5
    3
    Nasopharyngitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 43 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    4
    0
    3
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 43 (2.33%)
    4 / 48 (8.33%)
         occurrences all number
    1
    1
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2019
    - The exploratory assessments of contrast sensitivity and visual field were clarified to only be required from sites with appropriate capabilities. - An additional exploratory objective was added to explore the use of an advanced, artificial intelligence-based analytics tool to assess clinically relevant features. - An inclusion criterion was removed for consistency with the exclusion criteria. - It was clarified that the determination of natural progression of disease versus an adverse event (AE) was to be based upon Investigator opinion.
    13 Nov 2020
    - Operational procedures on Day 1 assessment were clarified. - An additional exploratory objective was added to explore potential effects of vicasinabin on glycemic status. - Operational updates related to COVID-19 were implemented, including a new assessment. - Clarifications and additional examples were added to both the inclusion and exclusion criteria. - The screen failure process was clarified. - Brolucizumab use was made to be an exception from permitted therapies and excluded as rescue treatment. - Disease-related AEs were further defined; clarifications were made to the number of assessments needed in case of rescue treatments for disease-related events; and follow up for disease-related AEs was specifically delineated. - Disease-related AEs (e.g., amputations, ulcers, diabetes-related surgery) and sight-threatening events (e.g., decrease of > 30 letters in visual acuity [VA] score, severe intraocular inflammation) were added as Adverse Events of Special Interest (AESIs); sight-threatening events were added under the definition of serious adverse events (SAEs). - Sample size and the efficacy analysis method were clarified, and a sensitivity analysis was added in case the amount of missing data exceeded 10% of all expected data.
    03 Feb 2021
    - An exclusion criterion regarding the location of an implantation of intraocular lens for the study eye was modified. - COVID-19 positive participants were added to the exclusion criteria. - The timing of additional visits for warfarin-taking participants was clarified.
    15 Jun 2021
    - The number of assessments and duration of patient visits were reduced. - Entry Criteria were modified to increase enrollment: an additional Diabetic Retinopathy Severity Scale (DRSS) rescreening was added, the glycosylated hemoglobin (HbA1c) threshold was increased to 12%, prior periocular pharmacological intervention was excluded, and participants without active hepatitis B virus or hepatitis C virus (HBC) and participants enrolled in other retinal/ovular clinical trials may be permitted in select circumstances. - The screen failure process was modified to allow participants who had previously failed according to outdated inclusion/exclusion criteria. - The process for evaluating ECG results was standardized. - Missing data treatment and the assessment of related efficacy estimates was clarified to be detailed in an external technical document.

    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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