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    Clinical Trial Results:
    A Prospective Randomised Controlled Trial of Intravitreal Ozurdex and Macular Laser Therapy versus Macular Laser Therapy only in Diabetic Macular Oedema (OZLASE study)

    Summary
    EudraCT number
    		 2011-003339-74
    Trial protocol
    		 GB  
    Global end of trial date
    22 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Aug 2019
    First version publication date
    01 Aug 2019
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    HYKP1016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Moorfields Eye Hospital NHS Foundation Trust
    Sponsor organisation address
    162, City Road, London, United Kingdom, EC1V 2PD
    Public contact
    Tania West, Moorfields Eye Hospital, 0044 2075662937, tania.west2@nhs.net
    Scientific contact
    Tania West, Moorfields Eye Hospital, 0044 2075662937, tania.west2@nhs.net
    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
    22 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the relative efficacy of repeated intravitreal Ozurdex + macular laser therapy versus macular laser therapy only in improving visual acuity and anatomical changes in eyes with diabetic macular oedema (DMO).
    Protection of trial subjects
    This trial is designed as a randomised clinical trial so that a direct comparison can be made between subjects receiving the combination therapy of ozurdex and macular laser therapy and macular laser therapy alone. While diabetic eye disease may affect both eyes of a single subject in a similar way, this is not always the case. In subjects where only one eye meets the inclusion criteria: the fellow eye (nonstudy eye) will be monitored during the course of the study by the trial investigators and will receive macular laser therapy in accordance with the NHS standard of care. In subjects where both eyes meet the inclusion criteria: the eye with the worse visual acuity will be included in the study and become the study eye. The fellow eye (nonstudy eye) will be treated in accordance with macular laser therapy as part of the NHS standard of care, and will continue to be monitored by the study investigators throughout the study and receive further treatment if required in accordance with the standard guidelines for treating diabetic eye disease. Study data will be anonymised to ensure compliance with the data protection act and patients will be given as much time as they need to decide whether they wish to participate in the study. All the research team are trained in GCP
    Background therapy
    		 The intervention arm of this study will receive 2 mandated doses of Ozurdex at baseline and 16 weeks and then repeated intravitreal Ozurdex and macular laser therapy at weeks 32 and 48 if retreatment criteria are met. The comparison group in the control arm of this study will receive macular laser therapy to the study eye at weeks 0, and at weeks 16, 32 and 48 if retreatment criteria are met. Treatment will be performed in both study arms according to modified ETDRS guidelines which is the current standard of care in UK clinical practice.
    Evidence for comparator
    		 Treatment will be performed in both study arms according to modified ETDRS guidelines which is the current standard of care in UK clinical practice.
    Actual start date of recruitment
    15 Sep 2011
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    43
    From 65 to 84 years
    35
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 219 patients were enrolled from October 2011 to August 2012 from Medical Retina Clinics at Moorfields Eye Hospital and its satellites. One eye per patient was enrolled in the trial. If both eyes of the patient met the eligibility criteria, the eye with the worse BCVA at baseline was designated as the study eye.

    Pre-assignment
    Screening details
    		 Full ophthalmic and medical history, refracted best corrected visual acuity, ophthalmic examination, LOCS II and IOP, blood pressure, HbA1C blood test, VFQ-25 and EQ-5D. Pregnancy test will be undertaken. Pupil dilation, 4-field stereo fundus photography, fluorescein angiography, and optical coherence tomography performed .

    Pre-assignment period milestones
    Number of subjects started
    		 80
    Number of subjects completed
    		 80

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The visual acuity examiners and OCT technicians (i.e. assessors) masked to the subject study arm. A masked observer used to determine whether a 10 or more decrease in BCVA letter score is attributable to cataract.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 combination arm of Ozurdex and laser photocoagulation
    Arm description
    		 The patients randomised to the combination arm received two mandated doses of Ozurdex at baseline and at week 16. Further re-treatment occurred at 32 or 48 weeks with a combination of Ozurdex and macular laser if retreatment criteria were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ozurdex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Other use
    Dosage and administration details
    Patients randomized to the combination arm received 2 mandated doses of Ozurdex at screening and week 16. Further re-treatment occurred at 32 or 48 weeks with a combination of Ozurdex and modified ETDRS macular laser therapy if re-treatment criteria were met. Ozurdex administered via intravitreal injection in accordance with a trial prescription.

    Arm title
    		 Laser
    Arm description
    		 Patients randomized to the laser arm received modified ETDRS macular laser therapy at screening and again at 16, 32 or 48 weeks if clinically significant macula oedema was present.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Laser
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ophthalmic insert
    Routes of administration
    Intraocular use
    Dosage and administration details
    The patients randomised to the MLT arm received laser therapy according to the modified Early Treatment Diabetic Retinopathy study (ETDRS) macular laser guidelines at screening and at 16, 32 or 48 weeks if the retreatment criteria were met.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Optometrists and OCT technicians were the assessors who were masked to treatment allocation
    Number of subjects in period 1
    		combination arm of Ozurdex and laser photocoagulation Laser
    Started
    40
    40
    Completed
    38
    39
    Not completed
    2
    1
         Adverse event, non-fatal
    1
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    combination arm of Ozurdex and laser photocoagulation
    Reporting group description
    		 The patients randomised to the combination arm received two mandated doses of Ozurdex at baseline and at week 16. Further re-treatment occurred at 32 or 48 weeks with a combination of Ozurdex and macular laser if retreatment criteria were met.

    Reporting group title
    Laser
    Reporting group description
    		 Patients randomized to the laser arm received modified ETDRS macular laser therapy at screening and again at 16, 32 or 48 weeks if clinically significant macula oedema was present.

    Reporting group values
    		 combination arm of Ozurdex and laser photocoagulation Laser Total
    Number of subjects
    		 40 40 80
    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
    Mean age in years (SD) Ozurdex +laser arm - 65.6 (10.6) Laser arm - 61.1 (12.8)
    Units: years
        arithmetic mean (standard deviation)
    		 65.6 ( 10.6 ) 61.1 ( 12.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 8 14
        Male
    		 34 32 66
    Type of diabetes
    Units: Subjects
        Type 1
    		 2 4 6
        Type 2
    		 38 36 74
    Visual acuity group
    Units: Subjects
        54-66 letters
    		 22 21 43
        67-78 letters
    		 18 19 37
    Lens status
    Units: Subjects
        Pseudophakic
    		 13 13 26
        Phakic
    		 27 27 54
    Duration of diabetes mellitus
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 15 (11 to 20) 15 (9 to 22.5) -
    HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    		 7.9 ( 1.2 ) 8.0 ( 1.4 ) -
    Systolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 130.7 ( 16.6 ) 130.8 ( 16.0 ) -
    Diastolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 72 ( 9.4 ) 76.1 ( 9.2 ) -
    ETDRS BCVA
    Units: letters
        arithmetic mean (standard deviation)
    		 66.1 ( 7.3 ) 66.6 ( 7.7 ) -
    Duration of CSMO
    Units: months
        median (inter-quartile range (Q1-Q3))
    		 25.5 (7.5 to 40.5) 41 (23.5 to 83.5) -
    number of prior macular laser therapies
    Units: number
        median (inter-quartile range (Q1-Q3))
    		 2 (1 to 3) 3 (2 to 4) -

    End points

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    End points reporting groups
    Reporting group title
    combination arm of Ozurdex and laser photocoagulation
    Reporting group description
    		 The patients randomised to the combination arm received two mandated doses of Ozurdex at baseline and at week 16. Further re-treatment occurred at 32 or 48 weeks with a combination of Ozurdex and macular laser if retreatment criteria were met.

    Reporting group title
    Laser
    Reporting group description
    		 Patients randomized to the laser arm received modified ETDRS macular laser therapy at screening and again at 16, 32 or 48 weeks if clinically significant macula oedema was present.

    Primary: Difference in mean best corrected ETDRS visual acuity (BCVA) letter score at 56 weeks between the two study arms

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    End point title
    		 Difference in mean best corrected ETDRS visual acuity (BCVA) letter score at 56 weeks between the two study arms
    End point description
    End point type
    Primary
    End point timeframe
    56 weeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    40
    40
    Units: ETDRS letters
        arithmetic mean (standard deviation)
    -0.3 ( 11.4 )
    0.4 ( 9.5 )
    Statistical analysis title
    		 Intention to treat population
    Statistical analysis description
    Descriptive statistics
    Comparison groups
    combination arm of Ozurdex and laser photocoagulation v Laser
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - The primary analyses of efficacy parameters were performed for the ITT population. A per protocol (PP) population, including only all randomised patients that had 12-month visual acuity data, was also conducted. A sensitivity analysis was performed to estimate the effect of cataract surgery done as PP and otherwise, for patients who underwent cataract surgery during the study. Missing BCVA data were imputed with the method of last observation carried forward.

    Secondary: Patients gaining ≥10 ETDRS letters at 56 weeks from baseline

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    End point title
    		 Patients gaining ≥10 ETDRS letters at 56 weeks from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    56 weeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    38
    39
    Units: number of participants/eyes
    7
    8
    No statistical analyses for this end point

    Secondary: Patients gaining ≥15 ETDRS letters at 56 weeks from baseline

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    End point title
    		 Patients gaining ≥15 ETDRS letters at 56 weeks from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    56 weeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    38
    39
    Units: number of participants/eyes
    6
    2
    No statistical analyses for this end point

    Secondary: Patients losing <15 ETDRS letters at 56 weeks from baseline,

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    End point title
    		 Patients losing <15 ETDRS letters at 56 weeks from baseline,
    End point description
    End point type
    Secondary
    End point timeframe
    56 weeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    38
    39
    Units: Number of participants/eyes
    35
    35
    No statistical analyses for this end point

    Secondary: Patients losing ≥30 ETDRS letters at 56 weeks from baseline

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    End point title
    		 Patients losing ≥30 ETDRS letters at 56 weeks from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    56 weeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    38
    39
    Units: number of participants/ eyes
    1
    0
    No statistical analyses for this end point

    Secondary: Change in ETDRS BCVA at 24 weeks from baseline

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    End point title
    		 Change in ETDRS BCVA at 24 weeks from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    56 weeeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    40
    40
    Units: ETDRS letters
        arithmetic mean (standard deviation)
    1.3 ( 8.8 )
    -0.7 ( 6.3 )
    No statistical analyses for this end point

    Secondary: Change in ETDRS BCVA at 40 weeks from baseline

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    End point title
    		 Change in ETDRS BCVA at 40 weeks from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    56 weeks
    End point values
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Number of subjects analysed
    40
    40
    Units: ETDRS letters
        arithmetic mean (standard deviation)
    -1.1 ( 12.8 )
    -0.1 ( 6.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    56 weeks
    Adverse event reporting additional description
    All adverse events (AEs) were recorded in the medical records and CRF until the patient completed their wk 56 visit. Severity, causality and expectedness were defined in the protocol and the SPC. All SAEs/SARs were recorded on the SAE form and reported to the sponsor within one working day unless otherwise specified in the protocol.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    combination arm of Ozurdex and laser photocoagulation
    Reporting group description
    		 The patients randomised to the combination arm received two mandated doses of Ozurdex at baseline and at week 16. Further re-treatment occurred at 32 or 48 weeks with a combination of Ozurdex and macular laser if retreatment criteria were met.

    Reporting group title
    Laser
    Reporting group description
    		 Patients randomized to the laser arm received modified ETDRS macular laser therapy at screening and again at 16, 32 or 48 weeks if clinically significant macula oedema was present.

    Serious adverse events
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 40 (37.50%)
    3 / 40 (7.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Arrythmia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac problem (unknown) with memory loss
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Admitted to care home for rehabilitation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract surgery - study eye
         subjects affected / exposed
    9 / 40 (22.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    5 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cataract surgery - fellow eye
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endonasal dacryocystorhinostomy - fellow eye
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Raised intra-ocular pressure
    Additional description: IOP >45 mmHg was defined as an SAE in the protocol
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ptosis repair
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal candidiasis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric bypass
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
    Additional description: hospitalisation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
    Additional description: Hospitalisation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetic ketoacidosis
    Additional description: Hospitalisation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteomyelitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back surgery
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amputation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture neck of femur
    Additional description: Hospitalisation for surgery
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device failure
    Additional description: Fragmented implant/incomplete insertion
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Salmonella infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 combination arm of Ozurdex and laser photocoagulation Laser
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 40 (87.50%)
    24 / 40 (60.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanoma
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Intermittent pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory infection
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Breathing difficulty and cough
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Product issues
    Device fault
    Additional description: Drug packaging contained no drug
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fluorescein angiography complications
    Additional description: adverse reaction, extravasation of dye, difficult cannulation
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Cardiac disorders
    Raised blood pressure
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Confusion and drowsiness
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Left sided weakness and dysphasia
    Additional description: Residual sequelae of stroke
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Amnesia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract progression - study eye
         subjects affected / exposed
    21 / 40 (52.50%)
    4 / 40 (10.00%)
         occurrences all number
    21
    4
    Cataract progression non study eye
         subjects affected / exposed
    5 / 40 (12.50%)
    0 / 40 (0.00%)
         occurrences all number
    5
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Corneal adverse events
    Additional description: Foreign body/abrasion/scar
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Progression of macular oedema - study eye
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Progression of macular oedema - fellow eye
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Floaters -study eye
         subjects affected / exposed
    5 / 40 (12.50%)
    0 / 40 (0.00%)
         occurrences all number
    6
    0
    Raised intraocular pressure
         subjects affected / exposed
    8 / 40 (20.00%)
    1 / 40 (2.50%)
         occurrences all number
    9
    1
    Eye pain
         subjects affected / exposed
    5 / 40 (12.50%)
    1 / 40 (2.50%)
         occurrences all number
    5
    1
    Posterior capsular opacification - study eye
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    Progression to proliferative diabetic retinopathy- study eye
         subjects affected / exposed
    1 / 40 (2.50%)
    4 / 40 (10.00%)
         occurrences all number
    1
    5
    Progression to proliferative diabetic retinopathy - fellow eye
         subjects affected / exposed
    4 / 40 (10.00%)
    4 / 40 (10.00%)
         occurrences all number
    5
    5
    Ptosis
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Subconjunctival hemorrhage
         subjects affected / exposed
    15 / 40 (37.50%)
    0 / 40 (0.00%)
         occurrences all number
    20
    0
    Post injection uveitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Blurred vision - study eye
         subjects affected / exposed
    7 / 40 (17.50%)
    0 / 40 (0.00%)
         occurrences all number
    7
    0
    visual field defect
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    vitreous hemorrhage - study eye
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    4
    Vitreous haemorrhage- fellow eye
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Nausea and vomiting
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Boils
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nephrotic syndrome with kidney infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypoglycemic episode
    Additional description: Diabetic patient
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Fluctuating diabetic control
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Infection
    Additional description: Osteomyelitis, ulcer
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Infections and infestations
    Flu with gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2013
    Amendment to the protocol, consent form and patient information sheet. The substantial amendment of the protocol, PIS and consent was a retrospective amendment to cover what was actually been undertaken for the study. This included the following: • Inclusion of cataract surgery within the study and clarification of referral for surgery • Definition of cataract • Amendment of the safety definitions and management of the study • Amendment of the SAP for the study

    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.
    The study did not have an Ozurdex monotherapy arm to evaluate the effect of withholding MLT completely. Under-reporting of AEs/SAEs was detected by QA and led to recognition of cataract as a SUSAR due to higher than expected frequency of occurrence.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26472406
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    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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