Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare the Efficacy and Safety of OZURDEX® Versus Lucentis® in Patients with Branch Retinal Vein Occlusion

    Summary
    EudraCT number
    2010-023900-29
    Trial protocol
    GB   DE   ES   IT  
    Global end of trial date
    04 Nov 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

    Close Top of page
    Trial identification
    Sponsor protocol code
    MAF-AGN-OPH-RET-004
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01427751
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Pharmaceuticals Ireland
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom,
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, +44 1628 494444,
    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
    28 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
    Protection of trial subjects
    All participants were required to read and sign an informed consent form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Oct 2011
    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
    France: 31
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Israel: 96
    Country: Number of subjects enrolled
    Italy: 27
    Country: Number of subjects enrolled
    Spain: 69
    Country: Number of subjects enrolled
    United Kingdom: 62
    Worldwide total number of subjects
    307
    EEA total number of subjects
    211
    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)
    123
    From 65 to 84 years
    167
    85 years and over
    17

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Participants took part in the study at 42 sites in France, Germany, Israel, Italy, Spain, and the United Kingdom from 11 Oct 2011 to 04 Nov 2014.

    Pre-assignment
    Screening details
    Participants with a diagnosis of Branch Retinal Vein Occlusion were enrolled in one of two treatment groups: OZURDEX® or Lucentis®.

    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
    Ozurdex®
    Arm description
    Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
    Arm type
    Active comparator

    Investigational medicinal product name
    Ozurdex®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravitreal implant in applicator
    Routes of administration
    Intravitreal use
    Dosage and administration details
    OZURDEX® intravitreal implant 700 µg

    Arm title
    Lucentis®
    Arm description
    Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
    Arm type
    Active comparator

    Investigational medicinal product name
    Lucentis®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Lucentis® intravitreal injection 10 mg/mL

    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
    Ozurdex® Lucentis®
    Started
    154
    153
    Completed
    112
    139
    Not completed
    42
    14
         Adverse event, serious fatal
    2
    -
         Adverse event, non-fatal
    18
    2
         Other miscellaneous reasons
    6
    4
         Withdrawal of consent
    2
    2
         No further treatment benefit expected
    5
    1
         Lost to follow-up
    3
    1
         Protocol deviation
    6
    4

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ozurdex®
    Reporting group description
    Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.

    Reporting group title
    Lucentis®
    Reporting group description
    Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.

    Reporting group values
    Ozurdex® Lucentis® Total
    Number of subjects
    154 153 307
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    52 71 123
        Elderly (From 65-84 years)
    92 75 167
        Elderly 85 years and over
    10 7 17
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    68.4 ± 10.58 65.5 ± 12.04 -
    Gender, Male/Female
    Units: participants
        Female
    62 66 128
        Male
    92 87 179

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Ozurdex®
    Reporting group description
    Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.

    Reporting group title
    Lucentis®
    Reporting group description
    Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.

    Primary: Change from Baseline in Best Corrected Visual Acuity (BCVA)

    Close Top of page
    End point title
    Change from Baseline in Best Corrected Visual Acuity (BCVA) [1]
    End point description
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    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
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: letters
    arithmetic mean (standard deviation)
        Baseline (n=153,153)
    56.6 ± 10.89
    59.2 ± 10.92
        Change from Baseline at Month 12 (n=153,151)
    7.9 ± 14.42
    16.9 ± 12.08
    No statistical analyses for this end point

    Secondary: Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)

    Close Top of page
    End point title
    Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
    End point description
    Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: microns
    arithmetic mean (standard deviation)
        Baseline (n=149, 149)
    553.2 ± 170.15
    561 ± 188.93
        Change from Baseline at Month 12 (n=140,144)
    -219.2 ± 180.51
    -253.5 ± 197.08
    No statistical analyses for this end point

    Secondary: Percentage of Patients with 15-or-More Letter Improvement in BCVA

    Close Top of page
    End point title
    Percentage of Patients with 15-or-More Letter Improvement in BCVA
    End point description
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: percentage of participants
        number (not applicable)
    33.8
    59.5
    No statistical analyses for this end point

    Secondary: Percentage of Patients with a 15-or-More Letter Decrease in BCVA

    Close Top of page
    End point title
    Percentage of Patients with a 15-or-More Letter Decrease in BCVA
    End point description
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: percentage of participants
        number (not applicable)
    9.1
    0.7
    No statistical analyses for this end point

    Secondary: Time to BCVA Improvement of 15-or-More Letters

    Close Top of page
    End point title
    Time to BCVA Improvement of 15-or-More Letters
    End point description
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: days
        arithmetic mean (standard deviation)
    73.7 ± 79.68
    82 ± 93.78
    No statistical analyses for this end point

    Secondary: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)

    Close Top of page
    End point title
    Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
    End point description
    The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=143,139)
    78.1 ± 16.58
    80.7 ± 14.34
        Change from Baseline at Month 12 (n=143, 139)
    3.5 ± 12.21
    6.6 ± 13.45
    No statistical analyses for this end point

    Secondary: Percentage of Participants not Completing the Month 12 Visit due to Treatment Failure

    Close Top of page
    End point title
    Percentage of Participants not Completing the Month 12 Visit due to Treatment Failure
    End point description
    Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    Ozurdex® Lucentis®
    Number of subjects analysed
    154
    153
    Units: percentage of participants
        number (not applicable)
    4.5
    0.7
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 60 Weeks
    Adverse event reporting additional description
    Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Lucentis®
    Reporting group description
    Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.

    Reporting group title
    Ozurdex®
    Reporting group description
    Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.

    Serious adverse events
    Lucentis® Ozurdex®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 150 (10.67%)
    12 / 153 (7.84%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site related reaction
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory distress
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitated depression
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (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 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (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 / 150 (0.00%)
    1 / 153 (0.65%)
         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 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (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
    Vertigo
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Ocular hypertension
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticulum intestinal
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (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
    Renal failure chronic
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endophthalmitis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Lucentis® Ozurdex®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    104 / 150 (69.33%)
    127 / 153 (83.01%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    16 / 150 (10.67%)
    50 / 153 (32.68%)
         occurrences all number
    28
    83
    Vascular disorders
    Hypertension
         subjects affected / exposed
    10 / 150 (6.67%)
    5 / 153 (3.27%)
         occurrences all number
    10
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 150 (6.00%)
    4 / 153 (2.61%)
         occurrences all number
    11
    4
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    17 / 150 (11.33%)
    28 / 153 (18.30%)
         occurrences all number
    20
    32
    Macular oedema
         subjects affected / exposed
    4 / 150 (2.67%)
    20 / 153 (13.07%)
         occurrences all number
    5
    25
    Visual acuity reduced
         subjects affected / exposed
    3 / 150 (2.00%)
    18 / 153 (11.76%)
         occurrences all number
    4
    22
    Cataract
         subjects affected / exposed
    2 / 150 (1.33%)
    13 / 153 (8.50%)
         occurrences all number
    2
    17
    Lenticular opacities
         subjects affected / exposed
    0 / 150 (0.00%)
    10 / 153 (6.54%)
         occurrences all number
    0
    10
    Ocular hypertension
         subjects affected / exposed
    1 / 150 (0.67%)
    9 / 153 (5.88%)
         occurrences all number
    2
    15
    Blepharitis
         subjects affected / exposed
    3 / 150 (2.00%)
    9 / 153 (5.88%)
         occurrences all number
    3
    9
    Dry eye
         subjects affected / exposed
    7 / 150 (4.67%)
    9 / 153 (5.88%)
         occurrences all number
    7
    9
    Vitreous floaters
         subjects affected / exposed
    9 / 150 (6.00%)
    9 / 153 (5.88%)
         occurrences all number
    11
    9
    Eye pain
         subjects affected / exposed
    9 / 150 (6.00%)
    6 / 153 (3.92%)
         occurrences all number
    13
    8
    Conjunctivitis
         subjects affected / exposed
    9 / 150 (6.00%)
    6 / 153 (3.92%)
         occurrences all number
    12
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 150 (3.33%)
    8 / 153 (5.23%)
         occurrences all number
    5
    9

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2011
    Amendment 1 provided for the following revisions: • Addition of secondary efficacy endpoint for treatment failures (proportion of subjects in each treatment arm not completing the Month 12 visit) • Addition of specific wording for the recommended dose and administration of Lucentis • Addition of wording to provide guidance to the investigator in the event that a subject is not responding to treatment • Addition of instructions for contraception to be continued for 3 months after the last Lucentis injection • Additional revisions included corrected typographical errors, removed confusing text on assignment of randomization numbers, and inserted specific temperature storage requirements for Lucentis and OZURDEX.
    13 Sep 2011
    Amendment 2 provided for the following revisions: • Clarification that treatment allocation was to be made at each investigational site, but randomization and stratification were centralized • Revision of fluorescein angiography (FA) text to correct an erroneous statement in the original protocol regarding certification of technicians conducting the single FA required at the screening visit. Certification of FA technicians was not required for this assessment.
    08 Nov 2012
    Amendment 3 provided for the following revisions: • Removal of inclusion criterion 3 that specified a separate data protection consent form (Authorization/Data Protection Form) for European sites • Revision of exclusion criterion 12 in line with new safety information regarding the status of the posterior capsule of the study eye • Removal of requirement that optical coherence tomography (OCT) technician be masked to study treatment assignment • Clarification of wording for serious adverse event (SAE)-reporting procedures after the final dose of study drug • Additional revisions included administrative changes, removal of any additional references to the Authorization/Data Protection Form, clearly defining that 1 month was considered equivalent to 28 days, and separation of assessments for the study eye and fellow eye in the Schedule of Visits and Procedures.

    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
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA