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    Clinical Trial Results:
    A randomized, active-controlled, open-label, multicenter proof-of concept study of intravitreal LFG316 in patients with active non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy

    Summary
    EudraCT number
    		 2011-003254-90
    Trial protocol
    		 GB  
    Global end of trial date
    24 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Aug 2018
    First version publication date
    31 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLFG316A2204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01526889
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    24 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of intravitreal LFG316 on the protocol defined, Day 85 response rate in eyes of patients who met the inclusion criteria. The above objective applied to the study eye only. A response was defined by any one of the following criteria in the study eye: • An improvement of 2 or more steps in vitreous haze, relative to baseline, or • An improvement of 10 or more letters in visual acuity, relative to baseline, or • An improvement of 2 or more steps in anterior chamber cells score, relative to baseline or • Absence of chorioretinal lesions as determined by the investigator Remission (complete response) was defined as any patient who had a vitreous haze score of 0 or 0.5 and who had an anterior chamber cell score of 0 and no chorioretinal lesions in the study eye and was off all immune modulatory therapy (systemic, corticosteroids and topical), without any worsening of uveitis during the trial.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 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 Kingdom: 6
    Country: Number of subjects enrolled
    United States: 19
    Worldwide total number of subjects
    25
    EEA total number of subjects
    6
    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)
    23
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Approximately 24 patients were planned to be enrolled. A total of 25 patients were randomized (18 patients in LFG316 group and 7 patients in conventional therapy group).

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LFG316
    Arm description
    		 LFG316 administered intravitreally
    Arm type
    		 Experimental

    Investigational medicinal product name
    LFG316
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The LFG316 solution for injection was a liquid solution.

    Arm title
    		 Conventional Therapy
    Arm description
    		 Conventional treatment was selected by the investigator.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Conventional therapy on site at the discretion of the investigator
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection, Coated tablet, Eye drops, suspension
    Routes of administration
    Intravitreal use, Intravascular use , Oral use, Subcutaneous use, Intravenous use, Ophthalmic use
    Dosage and administration details
    Depending on the conventional medications given, the dosage and administration varied (at the discretion of the investigator).

    Number of subjects in period 1
    		LFG316 Conventional Therapy
    Started
    18
    7
    Completed
    16
    7
    Not completed
    2
    0
         Adverse event, non-fatal
    2
    -
    Period 2
    Period 2 title
    Treatment extension period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 LFG316_extension period
    Arm description
    		 LFG316 administered intravitreally
    Arm type
    		 Experimental

    Investigational medicinal product name
    LFG316
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The LFG316 solution for injection was a liquid solution.

    Number of subjects in period 2 [1]
    		LFG316_extension period
    Started
    5
    Completed
    4
    Not completed
    1
         Administrative problems
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only five patients in the LFG316 group entered the treatment extension period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LFG316
    Reporting group description
    		 LFG316 administered intravitreally

    Reporting group title
    Conventional Therapy
    Reporting group description
    		 Conventional treatment was selected by the investigator.

    Reporting group values
    		 LFG316 Conventional Therapy Total
    Number of subjects
    		 18 7 25
    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)
    		 16 7 23
        From 65-84 years
    		 2 0 2
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 45.3 ( 14.84 ) 39.1 ( 14.89 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 7 4 11
        Male
    		 11 3 14
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 17 6 23
        Black
    		 1 1 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 2
        Not Hispanic or Latino
    		 16 7 23
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    LFG316
    Reporting group description
    		 LFG316 administered intravitreally

    Reporting group title
    Conventional Therapy
    Reporting group description
    		 Conventional treatment was selected by the investigator.
    Reporting group title
    LFG316_extension period
    Reporting group description
    		 LFG316 administered intravitreally

    Primary: Number of participants with response rate for the individual response criteria - in the study eye

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    End point title
    		 Number of participants with response rate for the individual response criteria - in the study eye [1]
    End point description
    Response rate as defined by: 1) An improvement of 2 or more steps in vitreous haze, relative to baseline OR 2) An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3) An improvement of 2 or more steps in anterior chamber cells (ACC) score, relative to baseline OR 4) Absence of chorioretinal lesions as determined by the investigator
    End point type
    Primary
    End point timeframe
    Day 85 (end of study)
    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: descriptive statistics
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    18
    7
    Units: Participants
        Improvement of vitreous haze ≥2 steps (N=15,6)
    3
    3
        Improvement of VA ≥ 10 letters (N=15,6)
    0
    1
        Improvement of ACC score ≥2 steps (N=7, 1)
    0
    0
        Resolution of chorioretinal lesions (N= 3, 0)
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with remission rate in study eye - treatment period

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    End point title
    		 Number of participants with remission rate in study eye - treatment period [2]
    End point description
    Remission (complete response) was defined as any patient who had: - a vitreous haze score of 0 or 0.5 in the study eye, AND - an anterior chamber cell score of 0, AND - no chorioretinal lesions in the study eye, AND - was off all immune modulatory therapy (systemic, corticosteroids and topical), AND - without any worsening of uveitis during the trial.
    End point type
    Primary
    End point timeframe
    Day 85 (end of study)
    Notes
    [2] - 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: descriptive statistics
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    18
    7
    Units: Participants
    2
    0
    No statistical analyses for this end point

    Secondary: Number of participants with vitreous haze score in study eye - treatment period

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    End point title
    		 Number of participants with vitreous haze score in study eye - treatment period
    End point description
    Vitreous haze score: 0, 0.5/Trace, 1+, 2+, 3+, 4+
    End point type
    Secondary
    End point timeframe
    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    18
    7
    Units: Participants
        Day 2|0
    0
    0
        Day 8|0
    0
    0
        Day 15|0
    2
    1
        Day 29|0
    0
    3
        Day 43|0
    6
    2
        Day 57|0
    5
    2
        Day 85 (end of study)|0
    2
    1
        Day 2|0.5/Trace
    2
    1
        Day 8|0.5/Trace
    1
    0
        Day 15|0.5/Trace
    3
    1
        Day 29|0.5/Trace
    4
    1
        Day 43|0.5/Trace
    1
    3
        Day 57|0.5/Trace
    5
    2
        Day 85 (end of study)|0.5/Trace
    6
    3
        Day 2|1+
    10
    4
        Day 8|1+
    4
    1
        Day 15|1+
    6
    4
        Day 29|1+
    10
    3
        Day 43|1+
    6
    1
        Day 57|1+
    4
    3
        Day 85 (end of study)|1+
    3
    2
        Day 2|2+
    1
    1
        Day 8|2+
    0
    0
        Day 15|2+
    3
    1
        Day 29|2+
    0
    0
        Day 43|2+
    0
    0
        Day 57|2+
    0
    0
        Day 85 (end of study)|2+
    3
    0
        Day 2|3+
    2
    1
        Day 8|3+
    1
    0
        Day 15|3+
    0
    0
        Day 29|3+
    0
    0
        Day 43|3+
    0
    0
        Day 57|3+
    0
    0
        Day 85 (end of study)|3+
    1
    0
        Day 2|4+
    0
    0
        Day 8|4+
    0
    0
        Day 15|4+
    2
    0
        Day 29|4+
    1
    0
        Day 43|4+
    1
    0
        Day 57|4+
    0
    0
        Day 85 (end of study)|4+
    0
    0
    No statistical analyses for this end point

    Secondary: Mean Best corrected visual acuity (BCVA) in study eye - treatment period

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    End point title
    		 Mean Best corrected visual acuity (BCVA) in study eye - treatment period
    End point description
    Visual acuity were measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded
    End point type
    Secondary
    End point timeframe
    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    18
    7
    Units: Mean BCVA
    arithmetic mean (standard deviation)
        Day 2
    72.5 ( 19.36 )
    76.1 ( 0.7 )
        Day 8
    80.5 ( 11.69 )
    79.0 ( 79 )
        Day 15
    68.8 ( 18.53 )
    78.9 ( 9.10 )
        Day 29
    70.3 ( 19.39 )
    79.6 ( 9.47 )
        Day 43
    65.5 ( 24.45 )
    77.3 ( 9.07 )
        Day 57
    72.6 ( 14.79 )
    80.1 ( 10.35 )
        Day 85
    72.1 ( 15.53 )
    76.7 ( 10.25 )
    No statistical analyses for this end point

    Secondary: Number of patients with macular edema in study eye - treatment period

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    End point title
    		 Number of patients with macular edema in study eye - treatment period
    End point description
    Macular edema is a sign of uveitis.
    End point type
    Secondary
    End point timeframe
    Day 85 (end of study)
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    10
    3
    Units: Participants
        Day 2
    2
    1
        Day 8
    1
    1
        Day 15
    3
    0
        Day 29
    2
    0
        Day 43
    2
    0
        Day 57
    2
    0
        Day 85 (end of study)
    2
    0
    No statistical analyses for this end point

    Secondary: Number of patients with chorioretinal lesions in study eye - treatment period

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    End point title
    		 Number of patients with chorioretinal lesions in study eye - treatment period
    End point description
    Chorioretinal lesions is a sign of uveitis.
    End point type
    Secondary
    End point timeframe
    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    10
    3
    Units: Participants
        Day 2
    3
    0
        Day 8
    2
    0
        Day 15
    4
    0
        Day 29
    5
    0
        Day 43
    4
    0
        Day 57
    5
    1
        Day 85 (end of study)
    4
    1
    No statistical analyses for this end point

    Secondary: Number of participants with anterior chamber cells score in study eye - treatment period

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    End point title
    		 Number of participants with anterior chamber cells score in study eye - treatment period
    End point description
    anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (>50 aqueous cells).
    End point type
    Secondary
    End point timeframe
    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    10
    3
    Units: Participants
        Day 2|0; <1 cell
    2
    0
        Day 8|0; <1 cell
    2
    0
        Day 15|0; <1 cell
    3
    1
        Day 29|0; <1 cell
    2
    1
        Day 43|0; <1 cell
    5
    1
        Day 57|0; <1 cell
    5
    1
        Day 85|0; <1 cell
    4
    3
        Day 2|0.5; 1-5 cells
    4
    1
        Day 8|0.5; 1-5 cells
    4
    1
        Day 15|0.5; 1-5 cells
    4
    0
        Day 29|0.5; 1-5 cells
    5
    0
        Day 43|0.5; 1-5 cells
    0
    0
        Day 57|0.5; 1-5 cells
    1
    1
        Day 85|0.5; 1-5 cells
    5
    0
        Day 2|1; 6-15 cells
    1
    0
        Day 8|1; 6-15 cells
    0
    0
        Day 15|1; 6-15 cells
    1
    0
        Day 29|1; 6-15 cells
    0
    0
        Day 43|1; 6-15 cells
    1
    0
        Day 57|1; 6-15 cells
    2
    0
        Day 85|1; 6-15 cells
    0
    0
        Day 2|2; 16-25 cells
    0
    0
        Day 8|2; 16-25 cells
    0
    0
        Day 15|2; 16-25 cells
    0
    0
        Day 29|2; 16-25 cells
    0
    0
        Day 43|2; 16-25 cells
    1
    0
        Day 57|2; 16-25 cells
    0
    0
        Day 85|2; 16-25 cells
    0
    0
        Day 2|3; 26-50 cells
    0
    0
        Day 8|3; 26-50 cells
    0
    0
        Day 15|3; 26-50 cells
    0
    0
        Day 29|3; 26-50 cells
    0
    0
        Day 43|3; 26-50 cells
    0
    0
        Day 57|3; 26-50 cells
    0
    0
        Day 85|3; 26-50 cells
    0
    0
        Day 2|4; >50 cells
    0
    0
        Day 8|4; >50 cells
    0
    0
        Day 15|4; >50 cells
    0
    0
        Day 29|4; >50 cells
    0
    0
        Day 43|4; >50 cells
    0
    0
        Day 57|4; >50 cells
    0
    0
        Day 85|4; >50 cells
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with or without anti-LFG316 antibodies

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    End point title
    		 Number of Participants with or without anti-LFG316 antibodies [3]
    End point description
    Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies [anti-drug antibodies]). NO: No immunogenicity; YES: Positive immunogenicity. with = w/ without = w/o antibodies = Ab EOS = end of study EOE = end of extension
    End point type
    Secondary
    End point timeframe
    Throughout the study (treatment and extension period)
    Notes
    [3] - 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: descriptive statistics
    End point values
    		 LFG316
    Number of subjects analysed
    17
    Units: Participants
        Day 1|participants w/ anti-LFG316 Ab
    3
        Day 29|participants w/ anti-LFG316 Ab
    3
        Day 85 (EOS)|participants w/ anti-LFG316 Ab
    2
        Day 169|participants w/ anti-LFG316 Ab
    1
        Day 253|participants w/ anti-LFG316 Ab
    0
        EOE period|participants w/ anti-LFG316 Ab
    1
        Day 1|participants w/o anti-LFG316 Ab
    12
        Day 29|participants w/o anti-LFG316 Ab
    10
        Day 85 (EOS)|participants w/o anti-LFG316 Ab
    9
        Day 169|participants w/o anti-LFG316 Ab
    1
        Day 253|participants w/o anti-LFG316 Ab
    1
        EOE period|participants w/o anti-LFG316 Ab
    0
    No statistical analyses for this end point

    Secondary: Mean Percent Change in Total C5 Concentrations in serum - treatment period

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    End point title
    		 Mean Percent Change in Total C5 Concentrations in serum - treatment period
    End point description
    Percent change from baseline (using each patient’s pre-dose value as baseline) in total C5 concentrations.
    End point type
    Secondary
    End point timeframe
    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
    End point values
    		 LFG316 Conventional Therapy
    Number of subjects analysed
    15
    7
    Units: percent change in C5
    arithmetic mean (standard deviation)
        Day 2
    6.80 ( 14.5 )
    1.02 ( 5.69 )
        Day 15
    8.21 ( 15.3 )
    -1.27 ( 19.7 )
        Day 29
    10.6 ( 17.4 )
    -8.33 ( 17.5 )
        Day 43
    8.38 ( 13.4 )
    6.46 ( 18.6 )
        Day 57
    6.73 ( 12.0 )
    5.98 ( 40.9 )
        Day 85
    3.21 ( 22.1 )
    1.28 ( 31.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    LFG316
    Reporting group description
    		 LF G316 administered intravitreally

    Reporting group title
    Conventional therapy
    Reporting group description
    		 Conventional therapy

    Serious adverse events
    		 LFG316 Conventional therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy proliferative
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (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
    Mycotic endophthalmitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (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
    		 LFG316 Conventional therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 18 (61.11%)
    5 / 7 (71.43%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Optic nerve cup/disc ratio increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cystoid macular oedema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Eye pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Hypotony of eye
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    Macular fibrosis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Ocular hypertension
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    Uveitis
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Visual impairment
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Vitreous floaters
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Giardiasis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2012
    This amendment was necessary to address a request from the MHRA. This included modification of the study stopping criteria making them absolute.
    18 Jan 2012
    During the course of this trial, a liquid formulation of LFG316 became available and was to be the primary formulation for use in future clinical investigation with LFG316. The CLFG316A2204 protocol at that time only referenced the LFG316 lyophilized powder formulation which was no longer being produced. To assure continuity in study conduct, this amendment included the option to use either formulation with relevant sections updated to reflect this change.
    08 Jul 2014
    Due to the difficulty of recruiting patients with multi-focal Choroiditis (MFC), the study population was expanded to include patients with active non-infectious intermediate-, posterior- or panuveitis (NIU) in at least one eye, requiring intensification of systemic immunosuppressive therapy. The Inclusion and Exclusion criteria were modified to reflect this broader uveitis population. The requirement for a score of vitreous haze of 2 was reduced to 1+ at Screening. The study stopping criteria were modified to align with other protocols in the LFG316 program. Safety data from recently completed intravenous and intravitreal studies of LFG316 was added. With respect to planned study assessments, the frequency of fundus photography was reduced as this was no longer necessary to follow the progression of disease. With the shift away from patients with MFC and need to monitor neovascularization, the inclusion of fluorescein angiography was removed. Spectral domain optical coherence tomography (OCT) was added at key time points before and after administration of LFG316 in order to profile the incidence and explore the effect of LFG316 administration on disease pathology such as CME, ERMs and vitreomacular traction associated with NIU. Overall, in consideration of these proposed changes, the risk/benefit profile of LFG316 in patients with NIU was expected to be the same as with the previous MFC population.
    22 Dec 2014
    This amendment was necessary to address a request from the UK Health Authority (MHRA). This included an update of the protocol to harmonize with the new Reference Safety Information (RSI) section in the current Investigator’s Brochure. With this update, the risk-benefit for patients with NIU remained the same.
    07 Sep 2015
    This amendment was implemented to allow a wider range of patients with uveitis the ability to participate in the study, and if they responded, to enable the patients to receive intravitreal LFG316 treatment for a longer period of time. To achieve these, the inclusion criteria and primary endpoint were updated and patients randomized to LFG316, who met the criteria for ‘responder’ and were willing to continue, were allowed to remain on therapy for an additional 6 months. The secondary endpoints were also updated to measure the mean changes in BCVA, vitreous haze score, anterior chamber cell score, and central retinal thickness and to assess the proportion of responders up to Day 281. To simplify the decision making for potential continuation, the primary endpoint was moved to Day 85 from Day 57. In addition, clarifications to the Exclusion criteria as well as an exploratory objective were proposed.

    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
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