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    Clinical Trial Results:
    Prevention of diabetic macular edema in patients with diabetic retinopathy treated with Ozurdex® after cataract surgery.

    Summary
    EudraCT number
    		 2011-006063-22
    Trial protocol
    		 ES  
    Global end of trial date
    03 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2024
    First version publication date
    12 Apr 2024
    Other versions
    Summary report(s)
    		 Final report

    Trial information

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    Trial identification
    Sponsor protocol code
    FOM-ICI01-2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Oftalmológica del Mediterráneo
    Sponsor organisation address
    Avinguda Pio Baroja, 12, Valencia, Spain, 46015
    Public contact
    Marisa Barón, Fundación Oftalmológica del Mediterraneo, +34 96 278 76 20, baron_margar@gva.es
    Scientific contact
    Marisa Barón, Fundación Oftalmológica del Mediterraneo, +34 96 278 76 20, baron_margar@gva.es
    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
    29 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy in reducing macular thickness at 6 months. The evolution of macular thickness after cataract surgery will be compared with the use of Ozurdex® versus a control group without treatment at 6 months.
    Protection of trial subjects
    The introduction of the phacoemulsification technique for cataract extraction (in which manages to reduce postoperative inflammation with respect to surgeries old as the extracapsular), good metabolic control by the patient and a good management of diabetic retinopathy prior to cataract surgery has achieved minimize this risk.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    3
    From 65 to 84 years
    33
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited for 34 months (from 03Jun2014 to 27Apr2017). Diabetic patients undergoing cataract surgery referred to FISABIO - Ophthalmology will be obtained Medical from regional hospitals without Retina Unit of the Valencian Community and sent by the ophthalmologist of corresponding area of ​​the Specialty Center of the Valencia.

    Pre-assignment
    Screening details
    		 Patients diagnosed with type I or II diabetes mellitus. Patients with diabetic macular edema affecting the fovea with OCT thickness >250 microns.Non-proliferative and inactive diabetic retinopathy (without areas of ischemia on angiography). Visual acuity greater than 0.1 on the decimal scale (34 letters ETDRS). Cataracts with surgical indication.

    Pre-assignment period milestones
    Number of subjects started
    		 37
    Number of subjects completed
    		 33

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening failure: 4
    Period 1
    Period 1 title
    OVERALL TRIAL (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ozurdex® treatment group
    Arm description
    		 50% of patients will be treated with intravitreal Ozurdex® implant after cataract surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ozurdex®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intraocular instillation solution
    Routes of administration
    Intravitreal use
    Dosage and administration details
    700 micrograms intravitreal implant in applicator after surgery of waterfalls

    Arm title
    		 Control group
    Arm description
    		 50% of patients will be only intervened in cataract surgery
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Ozurdex® treatment group Control group
    Started
    16
    17
    Completed
    15
    15
    Not completed
    1
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There were 4 screening failures for not meeting some study criteria, before cataract surgery.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ozurdex® treatment group
    Reporting group description
    		 50% of patients will be treated with intravitreal Ozurdex® implant after cataract surgery.

    Reporting group title
    Control group
    Reporting group description
    		 50% of patients will be only intervened in cataract surgery

    Reporting group values
    		 Ozurdex® treatment group Control group Total
    Number of subjects
    		 16 17 33
    Age categorical
    The median age among those treated with ozurdex is 74 years and the median age among those treated is 70 years.
    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)
    		 1 3 4
        From 65-84 years
    		 14 14 28
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 74.0 (64.0 to 89.0) 70.0 (53.0 to 84.0) -
    Gender categorical
    Units: Subjects
        Female
    		 7 6 13
        Male
    		 9 11 20

    End points

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    End points reporting groups
    Reporting group title
    Ozurdex® treatment group
    Reporting group description
    		 50% of patients will be treated with intravitreal Ozurdex® implant after cataract surgery.

    Reporting group title
    Control group
    Reporting group description
    		 50% of patients will be only intervened in cataract surgery

    Primary: Efficacy in reducing macular thickness at 6 months

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    End point title
    		 Efficacy in reducing macular thickness at 6 months
    End point description
    The evolution of macular thickness after cataract surgery with the use of Ozurdex® will be compared versus the control group without treatment at 6 months.
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Ozurdex® treatment group Control group
    Number of subjects analysed
    15
    15
    Units: microns
        median (standard deviation)
    311.1 ± 97.3
    334.6 ± 93.9
    Statistical analysis title
    		 ATS test of the Brunner-Langer
    Statistical analysis description
    ATS test of the Brunner-Langer model on the homogeneity of evolution of both groups. Mann-Whitney (MW) test on homogeneity between groups at a given time.
    Comparison groups
    Control group v Ozurdex® treatment group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.233
    Method
    		 Mann-Whitney
    Confidence interval

    Secondary: Impact on visual acuity

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    End point title
    		 Impact on visual acuity
    End point description
    Compare the impact on visual acuity after cataract surgery with the use of Ozurdex® versus the control group
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Ozurdex® treatment group Control group
    Number of subjects analysed
    15
    15
    Units: number of letters
        median (standard deviation)
    45.67 ± 8.69
    43.93 ± 9.80
    Statistical analysis title
    		 ATS test of the Brunner-Langer model
    Statistical analysis description
    ATS test of the Brunner-Langer model on the homogeneity of evolution of both groups. Mann-Whitney (MW) test on homogeneity between groups at a given time.
    Comparison groups
    Ozurdex® treatment group v Control group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.744
    Method
    		 Mann-Whitney
    Confidence interval

    Secondary: Impact on intraocular pressure

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    End point title
    		 Impact on intraocular pressure
    End point description
    Compare the impact on intraocular pressure after cataract surgery with the use of Ozurdex® versus the control group.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Ozurdex® treatment group Control group
    Number of subjects analysed
    15
    15
    Units: mmHg
        median (standard deviation)
    15.5 ± 2.2
    16.5 ± 2.5
    Statistical analysis title
    		 ATS test of the Brunner-Langer model
    Statistical analysis description
    ATS test of the Brunner-Langer model on the homogeneity of evolution of both groups. Mann-Whitney (MW) test on homogeneity between groups at a given time.
    Comparison groups
    Ozurdex® treatment group v Control group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.325
    Method
    		 Mann-Whitney
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    No adverse effect or serious adverse effect were recorded throughout the development of the trial.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 -

    Reporting group title
    Ozurdex treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 Control group Ozurdex treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control group Ozurdex treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 15 (46.67%)
    4 / 15 (26.67%)
    Cardiac disorders
    Heart failure
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    Eye disorders
    Increase ocular pressure
    Additional description: One patient had an increase the ocular pressure
         subjects affected / exposed
    7 / 15 (46.67%)
    4 / 15 (26.67%)
         occurrences all number
    0
    0
    Posterior vitreous detachment
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    Worsening macular edema
    Additional description: These patients required treatment with ozurdex.
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    Incipient membrane
    Additional description: One patient developed an incipient membrane
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    Discomfort due to dystischiasis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    Respiratory, thoracic and mediastinal disorders
    A cold
    Additional description: One patient had a cold
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    Respiratory insufficiency
    Additional description: One patient had a respiratory insufficiency
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    Renal and urinary disorders
    Urinary infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0

    More information

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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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    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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