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    Clinical Trial Results:
    Phase 1b/2a study of OPT-302 in combination with aflibercept for persistent central-involved diabetic macular edema

    Summary
    EudraCT number
    2018-003298-90
    Trial protocol
    LV  
    Global end of trial date
    11 Jun 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Jun 2022
    First version publication date
    16 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPT-302-1003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03397264
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Opthea Limited
    Sponsor organisation address
    Level 4, 650 Chapel Street, South Yarra, Australia, 3141
    Public contact
    Clinical Development, Opthea Ltd, 61 398260399, annette.leahy@opthea.com
    Scientific contact
    Clinical Development, Opthea Ltd, 61 398260399, annette.leahy@opthea.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
    17 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase 1b and 2a: To evaluate the safety and tolerability of OPT-302 intravitreal (IVT) injection in combination with IVT aflibercept in participants with central-involved Diabetic Macular Edema (DME) Phase 2b: To assess the response rate (≥ 5 letter gain in Best Corrected Visual Acuity [BCVA] from baseline to week 12according to ETDRS criteria) in participants with persistent central-involved DME receiving combination OPT-302 and aflibercept treatment
    Protection of trial subjects
    The study was conducted in accordance with the protocol and the following guidelines and regulations: • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice; • The Declaration of Helsinki; • United States (US) Food and Drug Administration (FDA) Human Participant Protection Regulations (Title 21 Code of Federal Regulations, Parts 50, 54, 56 & 312); • Local regulations in each of the participating countries. Before entering the study, the participant information and informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Feb 2018
    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
    Latvia: 9
    Country: Number of subjects enrolled
    Israel: 34
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    United States: 101
    Worldwide total number of subjects
    153
    EEA total number of subjects
    9
    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)
    96
    From 65 to 84 years
    55
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Nil

    Period 1
    Period 1 title
    Phase 2a (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
    Arm description
    2.0 mg aflibercept followed by 2.0 mg OPT-302 (0.05 mL each), both by intravitreal injection.
    Arm type
    Experimental

    Investigational medicinal product name
    OPT-302
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2.0 mg OPT-302 administered via Intravitreal Injection every 4 weeks x 3 treatments

    Investigational medicinal product name
    aflibercept
    Investigational medicinal product code
    Other name
    Eylea
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2.0 mg intravitreal aflibercept every 4 weeks x 3 treatments

    Arm title
    Phase 2a: 2.0 mg aflibercept with sham
    Arm description
    2.0 mg aflibercept (0.05 mL) followed by sham, both by intravitreal injection.
    Arm type
    Sham IVT injection

    Investigational medicinal product name
    Sham Intravitreal Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    Sham Intravitreal injection administered every 4 weeks x 3 treatments

    Number of subjects in period 1 [1]
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302 Phase 2a: 2.0 mg aflibercept with sham
    Started
    96
    48
    Completed
    89
    47
    Not completed
    7
    1
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    2
    1
         Protocol deviation
    2
    -
         not specified
    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: This was a two part study: a Ph1b open-label (unblinded) dose escalation (n=9) and Ph2a randomised (blinded) dose expansion study (n=144). A total of 153 participants were enrolled/randomised into the two different parts of the study. The baseline period represents the Ph2a randomised blinded dose expansion study (n=144) due to limitations of the EudraCT system to accomodate the blinded and unblinded phases of this study protocol.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
    Reporting group description
    2.0 mg aflibercept followed by 2.0 mg OPT-302 (0.05 mL each), both by intravitreal injection.

    Reporting group title
    Phase 2a: 2.0 mg aflibercept with sham
    Reporting group description
    2.0 mg aflibercept (0.05 mL) followed by sham, both by intravitreal injection.

    Reporting group values
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302 Phase 2a: 2.0 mg aflibercept with sham Total
    Number of subjects
    96 48 144
    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)
    58 32 90
        From 65-84 years
    36 16 52
        85 years and over
    2 0 2
    Gender categorical
    Units: Subjects
        Female
    36 18 54
        Male
    60 30 90

    End points

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    End points reporting groups
    Reporting group title
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
    Reporting group description
    2.0 mg aflibercept followed by 2.0 mg OPT-302 (0.05 mL each), both by intravitreal injection.

    Reporting group title
    Phase 2a: 2.0 mg aflibercept with sham
    Reporting group description
    2.0 mg aflibercept (0.05 mL) followed by sham, both by intravitreal injection.

    Subject analysis set title
    Primary Per Protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    This population was defined as the first 72 evaluable participants in the 2.0 mg OPT-302 with 2.0 mg aflibercept group from the PP population in the Phase 2a Study. Evaluable participants represent a subset of participants who were randomised, received the intended study product (a total of 3 scheduled intravitreal injections approximately once every 4 weeks), and could be evaluated for study outcomes

    Subject analysis set title
    Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population comprised all participants in the ITT population, but excluding those who did not receive at least one dose of study product(s) (aflibercept or OPT-302). Participants were analysed according to the treatment that they actually received.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The PP population comprised participants in the Safety population who were compliant with the study product, and who were considered sufficiently compliant with the protocol.

    Primary: Response Rate - Proportion of Participants Achieving a ≥ 5 letter Gain

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    End point title
    Response Rate - Proportion of Participants Achieving a ≥ 5 letter Gain [1] [2]
    End point description
    Response rate defined as the proportion of participants receiving the combination of OPT-302 and aflibercept achieving at least a 5 letter gain in BCVA at week 12 compared to Baseline according to the ETDRS criteria
    End point type
    Primary
    End point timeframe
    Baseline to Week 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: A one stage design was used for the primary endpoint based on the pre-specified response rate (38%) of a total of 72 evaluable patients receiving aflibercept + OPT-302. Clinical activity was concluded if ≥ 27 of 72 patients receiving 2 mg OPT-302 + 2 mg aflibercept had a ≥ 5 letter gain in BCVA from baseline to week 12; Type I and II error rates were set to 5% and with probability of at least 90%. The primary endpoint was met: response rate was 52.8% (95% CI: 41.2%; 64.3%).
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocol the study was a non-comparative, one stage design used for the primary outcome, with a pre-specified primary efficacy end point of a ≥ 5 letter vision gain (BCVA). OPT-302 combination therpay would be considered to have a clinical activity if ≥ 27 of 72 participants had a ≥ 5 letter gain from baseline to Week 12. The treatment response rate was selected because it represents a clinically relevant improvement in previously treated participants, based on published studies.
    End point values
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
    Number of subjects analysed
    72
    Units: Participants
    38
    No statistical analyses for this end point

    Secondary: Mean Change in BCVA

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    End point title
    Mean Change in BCVA
    End point description
    Mean Change in Best Corrected Visual Acuity (BCVA) Score. BCVA measured in accordance with Early Treatment Diabetic Retinopathy Score (ETDRS) criteria.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302 Phase 2a: 2.0 mg aflibercept with sham
    Number of subjects analysed
    75
    40
    Units: μm
        arithmetic mean (standard error)
    5.9 ( 0.79 )
    6.1 ( 0.96 )
    No statistical analyses for this end point

    Secondary: Mean Change in CST

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    End point title
    Mean Change in CST
    End point description
    Mean change in Central Subfield Thickness (CST) on spectral domain coherence tomography (SD-OCT)
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Phase 2a: 2.0 mg aflibercept with 2.0 mg OPT-302 Phase 2a: 2.0 mg aflibercept with sham
    Number of subjects analysed
    74
    39
    Units: μm
        arithmetic mean (standard error)
    -52.2 ( 10.28 )
    -34.9 ( 12.01 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 12
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Ph 1b: 2.0 mg Aflibercept with 0.3 mg OPT-302
    Reporting group description
    2.0 mg aflibercept intravitreal injection (0.05 mL) followed bu 0.3 mg OPT-302 intravitreal injection (0.5mL) every 4 weeks for 3 treatments

    Reporting group title
    Ph 1b: 2.0 mg Aflibercept with 1.0 mg OPT-302
    Reporting group description
    -

    Reporting group title
    Ph 1b: 2.0 mg Aflibercept with 2.0 mg OPT-302
    Reporting group description
    -

    Reporting group title
    Ph 2a: 2.0 mg Aflibercept with 2.0 mg OPT-302
    Reporting group description
    -

    Reporting group title
    Ph 2a: 2.0 mg Aflibercept with Sham
    Reporting group description
    -

    Serious adverse events
    Ph 1b: 2.0 mg Aflibercept with 0.3 mg OPT-302 Ph 1b: 2.0 mg Aflibercept with 1.0 mg OPT-302 Ph 1b: 2.0 mg Aflibercept with 2.0 mg OPT-302 Ph 2a: 2.0 mg Aflibercept with 2.0 mg OPT-302 Ph 2a: 2.0 mg Aflibercept with Sham
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    8 / 95 (8.42%)
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Ulcer
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Impaired gastric emptying
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 95 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 95 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 95 (2.11%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post Operative Wound infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 95 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 95 (1.05%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Ph 1b: 2.0 mg Aflibercept with 0.3 mg OPT-302 Ph 1b: 2.0 mg Aflibercept with 1.0 mg OPT-302 Ph 1b: 2.0 mg Aflibercept with 2.0 mg OPT-302 Ph 2a: 2.0 mg Aflibercept with 2.0 mg OPT-302 Ph 2a: 2.0 mg Aflibercept with Sham
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    36 / 95 (37.89%)
    15 / 49 (30.61%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    13 / 95 (13.68%)
    3 / 49 (6.12%)
         occurrences all number
    0
    0
    0
    13
    3
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    19 / 95 (20.00%)
    6 / 49 (12.24%)
         occurrences all number
    1
    1
    1
    19
    6
    Punctate keratitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 95 (2.11%)
    3 / 49 (6.12%)
         occurrences all number
    1
    0
    0
    2
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 95 (2.11%)
    3 / 49 (6.12%)
         occurrences all number
    0
    0
    0
    2
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2018
    • A four to six week Run In phase for potential participants who received prior bevacizumab therapy was added • The number of study sites was increased • CST inclusion criteria was revised.
    15 May 2018
    • The eligibility criteria for the Run In phase were revised • The number of study sites was increased • CST inclusion criterion revised • The duration of DME history inclusion criteria was revised.
    02 Aug 2018
    • Sections of the protocol were updated to accommodate study expansion into the EU e.g. contraception requirements. • Updated sections in the protocol for clarification and consistency.
    25 Mar 2020
    Changes to incorporate flexibility due to the COVID-19 pandemic.

    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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