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    Clinical Trial Results:
    Treatment of Cystoid Macular Edema following cataract surgery. A randomized, double-masked, placebo-controlled, clinical trial.

    Summary
    EudraCT number
    		 2009-017031-18
    Trial protocol
    		 NL  
    Global end of trial date
    08 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2016
    First version publication date
    17 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OZR-2009-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NTR2280
    Sponsors
    Sponsor organisation name
    The Rotterdam Eye Hospital
    Sponsor organisation address
    PO Box 70030, Rotterdam, Netherlands, 3000LM
    Public contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
    Scientific contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
    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 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To study the efficacy of treatment with Nevanac in combination with Pred Forte of acute clinical inflammation resulting in Cystoid Macular Edema after phacoemulsification.
    Protection of trial subjects
    With respect to the repetitive use of NSAIDs, patients were encouraged to seek early medical attention if symptoms of possible corneal problems were present; signs of corneal melting were checked during all follow-up visits to the outpatient clinic. Furthermore previous corneal problems were part of the exclusion criteria.
    Background therapy
    		 Cataract extraction is the most frequently performed surgical intervention. One of the most common causes of poor visual acuity after cataract surgery is the development of postoperative clinical (cystoid) macular edema ((C)ME). Several treatment options have been investigated, but a uniform treatment protocol does not exist. Current treatment strategies range from none to very intensive treatment with no strategy showing unambiguous benefits. However, based on our experience and extensive literature review, it is likely that a treatment using local application of a corticosteroid and a nonsteroidal anti-inflammatory drug will be optimal. Therefore, the aim of this study was to investigate the efficacy of treatment of CME with a combination of these types of drug.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jul 2010
    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
    Netherlands: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    11
    From 65 to 84 years
    13
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients diagnosed with clinical CME within three months after phacoemulsification were invited to participate.

    Pre-assignment
    Screening details
    		 Clinical CME in our study is defined as optical coherence tomography-evident (cystoid) macular edema in combination with reduced visual acuity.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo group
    Arm description
    		 Placebo eyedrops in two separate phials.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Placebo eye drops, 3 times a day, during 6 weeks.

    Arm title
    		 Active substances
    Arm description
    		 Treatment with nepafenac 0.1% eye drops & prednisolone acetate 1% eye drops.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nepafenac
    Investigational medicinal product code
    EU/1/07/433/001
    Other name
    Nevanac
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    0.1% eye drops, 3 times a day, during 6 weeks.

    Investigational medicinal product name
    prednisolone acetate
    Investigational medicinal product code
    RVG11271
    Other name
    PredForte
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1% eye drops, 3 times a day, during 6 weeks.

    Number of subjects in period 1
    		Placebo group Active substances
    Started
    10
    15
    Completed
    2
    6
    Not completed
    8
    9
         Lost to follow-up
    8
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo eyedrops in two separate phials.

    Reporting group title
    Active substances
    Reporting group description
    		 Treatment with nepafenac 0.1% eye drops & prednisolone acetate 1% eye drops.

    Reporting group values
    		 Placebo group Active substances Total
    Number of subjects
    		 10 15 25
    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
    Units: years
        arithmetic mean (standard deviation)
    		 66 ( 13 ) 68 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 9 13
        Male
    		 6 6 12

    End points

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    End points reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo eyedrops in two separate phials.

    Reporting group title
    Active substances
    Reporting group description
    		 Treatment with nepafenac 0.1% eye drops & prednisolone acetate 1% eye drops.

    Primary: Letters gained.

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    End point title
    		 Letters gained. [1]
    End point description
    Letters gained (ETDRS chart) at last FU visit.
    End point type
    Primary
    End point timeframe
    Last follow up visit.
    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: The number of subjects included in this study did not warrant any further statistical analysis.
    End point values
    		 Placebo group Active substances
    Number of subjects analysed
    9
    9
    Units: Letters
        arithmetic mean (standard deviation)
    11 ( 15 )
    12 ( 6 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    One year after diagnosis of CME.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo eyedrops in two separate phials.

    Reporting group title
    Active substances
    Reporting group description
    		 Treatment with nepafenac 0.1% eye drops & prednisolone acetate 1% eye drops.

    Serious adverse events
    		 Placebo group Active substances
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo group Active substances
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 15 (6.67%)
    General disorders and administration site conditions
    Allergic keratitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1

    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? Yes
    Date
    Interruption
    Restart date
    08 Jun 2015
    Premature termination of the trial.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This trial was designed as RCT with two arms of 60 subjects each. It was prematurely terminated after inclusion of 10 subject in the placebo arm and 15 in the experimental arm. No further statistical analysis was performed.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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