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    Clinical Trial Results:
    A Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of 700 μg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) to Ranibizumab in Patients With Diabetic Macular Edema

    Summary
    EudraCT number
    2011-005631-20
    Trial protocol
    DE   BE   PT   SE   ES   GB   NL   AT   DK   IT  
    Global end of trial date
    13 Feb 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Apr 2016
    First version publication date
    21 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    206207-024
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01492400
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.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
    21 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether treatment with 700 μg DEX PS DDS every 5 months provides a similar treatment effect on average change of best-corrected visual acuity (BCVA) as ranibizumab administered as per its European Summary of Product Characteristics (SmPC) in patients with DME
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form .
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Mar 2012
    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
    United States: 143
    Country: Number of subjects enrolled
    United Kingdom: 29
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    France: 33
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Israel: 85
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    Netherlands Antilles: 2
    Country: Number of subjects enrolled
    Portugal: 17
    Country: Number of subjects enrolled
    South Africa: 2
    Worldwide total number of subjects
    363
    EEA total number of subjects
    131
    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)
    187
    From 65 to 84 years
    173
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients were screened up to 2 weeks prior to randomization on Day 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    dexamethasone Intravitreal Implant
    Arm description
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
    Arm type
    Experimental

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.

    Arm title
    ranibizumab
    Arm description
    Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
    Arm type
    Active comparator

    Investigational medicinal product name
    ranibizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Only the Outcome Assessor was blinded for this trial.
    Number of subjects in period 1
    dexamethasone Intravitreal Implant ranibizumab
    Started
    181
    182
    Completed
    165
    166
    Not completed
    16
    16
         Adverse event, non-fatal
    10
    5
         Miscellaneous Reasons
    2
    3
         Pregnancy
    -
    1
         Personal Reasons
    -
    5
         Lost to follow-up
    3
    1
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    dexamethasone Intravitreal Implant
    Reporting group description
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.

    Reporting group title
    ranibizumab
    Reporting group description
    Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

    Reporting group values
    dexamethasone Intravitreal Implant ranibizumab Total
    Number of subjects
    181 182 363
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    98 89 187
        From 65-84 years
    81 92 173
        85 years and over
    2 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.4 ± 9.39 63.7 ± 10.05 -
    Gender, Male/Female
    Units: Participants
        Female
    69 66 135
        Male
    112 116 228

    End points

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    End points reporting groups
    Reporting group title
    dexamethasone Intravitreal Implant
    Reporting group description
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.

    Reporting group title
    ranibizumab
    Reporting group description
    Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

    Primary: Average Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

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    End point title
    Average Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [1]
    End point description
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
    End point type
    Primary
    End point timeframe
    Baseline, 12 Months
    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: No Statistical Analysis is reported for this outcome measure.
    End point values
    dexamethasone Intravitreal Implant ranibizumab
    Number of subjects analysed
    181
    182
    Units: Letters
    arithmetic mean (standard deviation)
        Baseline
    60.2 ± 9.74
    60.4 ± 9.34
        Change from Baseline at 12 Months
    4.34 ± 7.342
    7.6 ± 6.735
    No statistical analyses for this end point

    Secondary: Change from Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye

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    End point title
    Change from Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye
    End point description
    OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    dexamethasone Intravitreal Implant ranibizumab
    Number of subjects analysed
    181
    182
    Units: Microns
    arithmetic mean (standard deviation)
        Baseline
    465.1 ± 136.09
    471.2 ± 139.51
        Change from Baseline at Month 12 (N=163, 166)
    -173.9 ± 129.64
    -163.5 ± 161.34
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)

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    End point title
    Change from Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)
    End point description
    FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    dexamethasone Intravitreal Implant ranibizumab
    Number of subjects analysed
    172
    177
    Units: Square Millimeters (mm^2)
    arithmetic mean (standard deviation)
        Baseline
    19.2 ± 13.01
    18.9 ± 12.55
        Change from Baseline at Month 12 (N=125, 142)
    -16.1 ± 11.64
    -12 ± 10.54
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    dexamethasone Intravitreal Implant
    Reporting group description
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.

    Reporting group title
    ranibizumab
    Reporting group description
    Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

    Serious adverse events
    dexamethasone Intravitreal Implant ranibizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    40 / 181 (22.10%)
    41 / 182 (22.53%)
         number of deaths (all causes)
    3
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    3 / 181 (1.66%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Squamous Cell Carcinoma Metastatic
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mantle Cell Lymphoma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm Malignant
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of the Tongue
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic Hypotension
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac Pacemaker Insertion
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposuction
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Local Swelling
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         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
    Endometrial Hyperplasia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    2 / 181 (1.10%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Depression
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Intraocular Pressure Increased
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip Fracture
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    4 / 181 (2.21%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Stenosis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachyarrhythmia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand Mal Convulsion
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningorrhagia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Sudden Hearing Loss
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Open Angle Glaucoma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroiditis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacrimation Increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Haemorrhage
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic Foot
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure Acute
         subjects affected / exposed
    4 / 181 (2.21%)
    3 / 182 (1.65%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure Chronic
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Failure
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         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
    Rotator Cuff Syndrome
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney Infection
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wall Abscess
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical Pneumonia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Bites
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 181 (1.10%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    dexamethasone Intravitreal Implant ranibizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    160 / 181 (88.40%)
    104 / 182 (57.14%)
    Investigations
    Intraocular Pressure Increased
         subjects affected / exposed
    65 / 181 (35.91%)
    12 / 182 (6.59%)
         occurrences all number
    117
    22
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 181 (4.42%)
    10 / 182 (5.49%)
         occurrences all number
    11
    10
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 181 (3.31%)
    10 / 182 (5.49%)
         occurrences all number
    5
    14
    Eye disorders
    Conjunctival Haemorrhage
         subjects affected / exposed
    36 / 181 (19.89%)
    24 / 182 (13.19%)
         occurrences all number
    51
    52
    Vitreous Haemorrhage
         subjects affected / exposed
    22 / 181 (12.15%)
    7 / 182 (3.85%)
         occurrences all number
    27
    7
    Cataract
         subjects affected / exposed
    28 / 181 (15.47%)
    8 / 182 (4.40%)
         occurrences all number
    33
    13
    Visual Acuity Reduced
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 181 (7.73%)
    5 / 182 (2.75%)
         occurrences all number
    16
    6
    Cataract Subcapsular
         subjects affected / exposed
    14 / 181 (7.73%)
    1 / 182 (0.55%)
         occurrences all number
    20
    2
    Vitreous Floaters
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 181 (7.18%)
    2 / 182 (1.10%)
         occurrences all number
    20
    6
    Ocular Hypertension
         subjects affected / exposed
    11 / 181 (6.08%)
    2 / 182 (1.10%)
         occurrences all number
    19
    3
    Eye Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 181 (5.52%)
    6 / 182 (3.30%)
         occurrences all number
    15
    7
    Diabetic Retinal Oedema
         subjects affected / exposed
    10 / 181 (5.52%)
    5 / 182 (2.75%)
         occurrences all number
    11
    6
    Vitreous Detachment
         subjects affected / exposed
    10 / 181 (5.52%)
    5 / 182 (2.75%)
         occurrences all number
    11
    8
    Punctate Keratitis
         subjects affected / exposed
    9 / 181 (4.97%)
    3 / 182 (1.65%)
         occurrences all number
    9
    3
    Macular Oedema
         subjects affected / exposed
    3 / 181 (1.66%)
    10 / 182 (5.49%)
         occurrences all number
    3
    15
    Infections and infestations
    Influenza
         subjects affected / exposed
    9 / 181 (4.97%)
    4 / 182 (2.20%)
         occurrences all number
    9
    4

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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    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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