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    Clinical Trial Results:
    A PHASE 2, RANDOMISED, DOUBLE-MASKED, SHAM-CONTROLLED, MULTI-CENTRE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT (PVD) IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR) (CIRCLE)

    Summary
    EudraCT number
    		 2015-002415-15
    Trial protocol
    		 DE   GB   CZ   BE   HU   ES   FR   IT  
    Global end of trial date
    18 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TG-MV-015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02681809
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ThromboGenics
    Sponsor organisation address
    Gaston Geenslaan 1, Leuven, Belgium, B-3001
    Public contact
    Global Clinical Development, ThromboGenics, 32 (0)16751310, info@oxurion.com
    Scientific contact
    Global Clinical Development, ThromboGenics, 32 (0)16751310, info@oxurion.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
    13 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe NPDR, to induce total PVD in order to reduce the risk of disease progression to PDR
    Protection of trial subjects
    All study procedures, including the intravitreal injections, were performed by qualified and trained personnel. Only eligible subjects were randomised and only subjects who did not meet any withdrawal criteria received repeat injections. All subjects were supervised in the immediate post-injection period with appropriate medical treatment readily available. Subjects were followed up for 24 months after the first injection. Adverse events were recorded throughout the study period. At each study visit, a full ophthalmic examination and BCVA assessment were performed. An independent DMC was established to maintain a general safety oversight and to monitor the benefit / risk balance for the subjects in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 22 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    48
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a Screening visit during which in- and exclusion criteria were checked by the Investigator. In addition, specific criteria needed to be confirmed by the central reading center / by the central laboratory

    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, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    IMP handling and administration was done by unmasked personnel

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ocriplasmin 0.0625mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ocriplasmin 0.5 mg/0.2 mL concentrate for solution for injection
    Investigational medicinal product code
    Other name
    JETREA 0.5 mg/0.2 mL concentrate for solution for injection
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    up to 3 intravitreal injections with ocriplasmin 0.0625mg, approximately 1 month apart

    Arm title
    		 ocriplasmin 0.125mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ocriplasmin 0.5 mg/0.2 mL concentrate for solution for injection
    Investigational medicinal product code
    Other name
    JETREA 0.5 mg/0.2 mL concentrate for solution for injection
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    up to 3 intravitreal injections with ocriplasmin 0.125mg, approximately 1 month apart

    Arm title
    		 sham
    Arm description
    		 Subjects in this arm received a sham injection. There was no penetration of the globe; Investigator mimicked intravitreal injection procedure.
    Arm type
    		 sham injection

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		ocriplasmin 0.0625mg ocriplasmin 0.125mg sham
    Started
    20
    19
    9
    Completed
    15
    15
    8
    Not completed
    5
    4
    1
         Consent withdrawn by subject
    3
    1
    -
         Adverse event, non-fatal
    -
    1
    1
         Lost to follow-up
    2
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ocriplasmin 0.0625mg
    Reporting group description
    		 -

    Reporting group title
    ocriplasmin 0.125mg
    Reporting group description
    		 -

    Reporting group title
    sham
    Reporting group description
    		 Subjects in this arm received a sham injection. There was no penetration of the globe; Investigator mimicked intravitreal injection procedure.

    Reporting group values
    		 ocriplasmin 0.0625mg ocriplasmin 0.125mg sham Total
    Number of subjects
    		 20 19 9 48
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 14 6 32
        From 65-84 years
    		 8 5 3 16
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.7 ( 12.14 ) 55.4 ( 10.15 ) 54.3 ( 13.01 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 5 2 13
        Male
    		 14 14 7 35

    End points

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    End points reporting groups
    Reporting group title
    ocriplasmin 0.0625mg
    Reporting group description
    		 -

    Reporting group title
    ocriplasmin 0.125mg
    Reporting group description
    		 -

    Reporting group title
    sham
    Reporting group description
    		 Subjects in this arm received a sham injection. There was no penetration of the globe; Investigator mimicked intravitreal injection procedure.

    Primary: Total PVD by the Month 3 visit, confirmed on both B-scan ultrasound and SD-OCT (6mm), as assessed by the masked B-scan expert reader and the masked CRC, respectively

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    End point title
    		 Total PVD by the Month 3 visit, confirmed on both B-scan ultrasound and SD-OCT (6mm), as assessed by the masked B-scan expert reader and the masked CRC, respectively [1]
    End point description
    End point type
    Primary
    End point timeframe
    at Month 3
    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: Recruitment in the study was discontinued early due to slow recruitment rate. This led to a total of 48 randomized subjects instead of the planned 115 per protocol amendment 2. By consequence, the study was not powered for its primary endpoint. The endpoint was therefore evaluated only descriptively. No statistical hypothesis testing was performed.
    End point values
    		 ocriplasmin 0.0625mg ocriplasmin 0.125mg sham
    Number of subjects analysed
    20
    18
    8
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Ocular treatment-emergent adverse events in the study eye

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    End point title
    		 Ocular treatment-emergent adverse events in the study eye
    End point description
    Incidence of ocular treatment-emergent adverse events in the study eye
    End point type
    Secondary
    End point timeframe
    From first injection until the end of the study (Month 24)
    End point values
    		 ocriplasmin 0.0625mg ocriplasmin 0.125mg sham
    Number of subjects analysed
    20
    19
    9
    Units: subjects
    15
    14
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first injection until the end of the study (Month 24)
    Adverse event reporting additional description
    Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    ocriplasmin 0.0625mg
    Reporting group description
    		 -

    Reporting group title
    ocriplasmin 0.125mg
    Reporting group description
    		 -

    Reporting group title
    sham
    Reporting group description
    		 Subjects in this arm received a sham injection. There was no penetration of the globe; Investigator to mimic intravitreal injection procedure.

    Serious adverse events
    		 ocriplasmin 0.0625mg ocriplasmin 0.125mg sham
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    8 / 19 (42.11%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of Colon
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Injury, poisoning and procedural complications
    Craniocerebral Injury
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Patella Fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Pelvic Fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Vascular disorders
    Peripheral Ischaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (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
    Cardiac Failure
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (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
    General disorders and administration site conditions
    Generalised Oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (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
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Ciliary Zonular Dehiscence
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal Haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (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
    Uveitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Respiratory Failure
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Wall Abscess
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Catheter Site Cellulitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Endophthalmitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (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
    Pneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ocriplasmin 0.0625mg ocriplasmin 0.125mg sham
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 20 (80.00%)
    17 / 19 (89.47%)
    7 / 9 (77.78%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 19 (10.53%)
    1 / 9 (11.11%)
         occurrences all number
    1
    3
    1
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral Ischaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    2
    Gait Disturbance
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary Hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Intraocular Pressure Increased
         subjects affected / exposed
    4 / 20 (20.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    6
    0
    2
    Glycosylated Haemoglobin Increased
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 19 (15.79%)
    0 / 9 (0.00%)
         occurrences all number
    0
    3
    0
    Intraocular Pressure Decreased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Pelvic Fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Post Procedural Oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Radius Fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Colour Blindness
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Cardiac Failure
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
         occurrences all number
    2
    2
    0
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Loss of Consciousness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Paralysis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eye Pain
         subjects affected / exposed
    2 / 20 (10.00%)
    5 / 19 (26.32%)
    1 / 9 (11.11%)
         occurrences all number
    2
    7
    1
    Diabetic Retinal Oedema
         subjects affected / exposed
    4 / 20 (20.00%)
    1 / 19 (5.26%)
    2 / 9 (22.22%)
         occurrences all number
    4
    3
    3
    Cataract
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 19 (15.79%)
    0 / 9 (0.00%)
         occurrences all number
    4
    4
    0
    Visual Acuity Reduced
         subjects affected / exposed
    2 / 20 (10.00%)
    4 / 19 (21.05%)
    0 / 9 (0.00%)
         occurrences all number
    2
    4
    0
    Vitreous Floaters
         subjects affected / exposed
    2 / 20 (10.00%)
    3 / 19 (15.79%)
    0 / 9 (0.00%)
         occurrences all number
    2
    6
    0
    Conjunctival Haemorrhage
         subjects affected / exposed
    4 / 20 (20.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    4
    1
    0
    Macular Oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 19 (21.05%)
    0 / 9 (0.00%)
         occurrences all number
    0
    5
    0
    Visual Impairment
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    4
    1
    0
    Vitreous Haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 19 (15.79%)
    0 / 9 (0.00%)
         occurrences all number
    2
    3
    0
    Photophobia
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
         occurrences all number
    1
    4
    0
    Photopsia
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
         occurrences all number
    1
    4
    0
    Diabetic Retinopathy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    0
    2
    Dry Eye
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 19 (10.53%)
    1 / 9 (11.11%)
         occurrences all number
    0
    3
    1
    Eye Irritation
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 19 (10.53%)
    1 / 9 (11.11%)
         occurrences all number
    0
    3
    1
    Macular Fibrosis
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    3
    1
    0
    Retinal Haemorrhage
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    2
    1
    0
    Vision Blurred
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    1
    Cataract Subcapsular
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
         occurrences all number
    0
    3
    0
    Lacrimation Increased
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    Punctate Keratitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    1
    Cataract Cortical
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Iridocyclitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Lenticular Opacities
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    Ocular Hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    Cataract Nuclear
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Corneal Oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Cystoid Macular Oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid Ptosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular Hyperaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Optic Disc Haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Optic Nerve Disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal Aneurysm
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal Cyst
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal Detachment
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Retinal Exudates
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal Sphincter Insufficiency
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Herpetiformis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    1
    Musculoskeletal and connective tissue disorders
    Joint Swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 20 (10.00%)
    3 / 19 (15.79%)
    2 / 9 (22.22%)
         occurrences all number
    2
    3
    2
    Cellulitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Localised Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    Nosocomial Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2016
    Sample size was reduced and eligibility criteria were updated to improve recruitment

    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.
    Recruitment in the study was discontinued early due to slow recruitment rate. This led to a total of 48 randomized subjects instead of the planned 115 per protocol amendment 2. By consequence, the study was not powered for its primary endpoint.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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