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    Clinical Trial Results:
    A Phase 2A Open-Label Trial to Assess the Safety of Zimura™ (Anti-C5) Administered in Combination With Lucentis® 0.5 mg in Treatment Naïve Subjects with Neovascular Age Related Macular Degeneration

    Summary
    EudraCT number
    		 2017-003923-31
    Trial protocol
    		 LV   HU  
    Global end of trial date
    18 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPH2007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03362190
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IVERIC bio, Inc. (formerly Ophthotech Corporation)
    Sponsor organisation address
    Five Penn Plaza, Suite 2372, New York, United States,
    Public contact
    Medical Director, IVERIC bio, Inc., clinicaltrials@ivericbio.com
    Scientific contact
    Medical Director, IVERIC bio, Inc., clinicaltrials@ivericbio.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
    18 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of intravitreal Zimura™ administered in combination with Lucentis® in treatment naïve subjects with NVAMD
    Protection of trial subjects
    The study was conducted in full compliance with the principles of the Declaration of Helsinki and in line with the principles outlined in the Guideline for Good Clinical Practice (GCP), the International Council for Harmonisation (ICH) Tripartite Guideline (May 1997). Before initiation of the study, the protocol and the subject informed consent provisions were reviewed and approved by the appropriate independent ethics committees (IECs) for each of the centers involved in the study. Study initiation at each site began only after receiving written approval from the IEC. Prior to study entry, all subjects were informed fully of the nature and aims of the study. Ample time was provided for the subjects to read the subject information sheet and ask any questions regarding the investigational drug. Subjects were informed that their participation was voluntary and that they could withdraw from the study at any time for any reason without incurring any penalty or withholding of treatment on the part of the investigator. Before receiving any treatment related to this study, all subjects provided their written informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2017
    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
    United States: 45
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Latvia: 6
    Worldwide total number of subjects
    64
    EEA total number of subjects
    19
    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)
    5
    From 65 to 84 years
    49
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion: active subfoveal NVAMD, ≥50 years Exclusion: severe cardiac disease, major surgical procedure <1 month of trial entry, clinically significant laboratory value, treatment with investigational agent <60 days of trial, women who are pregnant or nursing, known relevant serious allergies, prior AMD treatment (excl vitamin/mineral supplement)

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zimura
    Investigational medicinal product code
    Other name
    avacincaptad pegol
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2 x 2 mg intravitreal injections in the study eye, administered once per month for 6 doses in total. Zimura injections were administered 2 days after the Lucentis injections.

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    ranibizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/intravitreal injection in the study eye, administered once per month for 6 doses in total.

    Arm title
    		 Cohort 2
    Arm description
    		 Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zimura
    Investigational medicinal product code
    Other name
    avacincaptad pegol
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    1 x 2 mg intravitreal injections in the study eye, administered once per month for 6 doses in total. Zimura injections were administered on the same day as the Lucentis injections.

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    ranibizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/intravitreal injection in the study eye, administered once per month for 6 doses in total.

    Arm title
    		 Cohort 3
    Arm description
    		 Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zimura
    Investigational medicinal product code
    Other name
    avacincaptad pegol
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    1 x 2 mg intravitreal injections in the study eye, administered every 14 days for 3 months (Induction Phase) and once per month for the subsequent 3 months (Maintenance Phase). When applicable, Zimura injections were administered on the same day as the Lucentis injections.

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    ranibizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/intravitreal injection in the study eye, administered once per month for 6 doses in total.

    Arm title
    		 Cohort 4
    Arm description
    		 Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura & 3 doses Lucentis)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zimura
    Investigational medicinal product code
    Other name
    avacincaptad pegol
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    1 x 2 mg intravitreal injections in the study eye, administered every 14 days for 3 months (Induction Phase) and twice per month (2 days apart) for the subsequent 3 months (Maintenance Phase). When applicable, Zimura injections were administered on the same day as the Lucentis injections (day 0 during the Induction Phase and Day 2 during the Maintenance Phase).

    Investigational medicinal product name
    Lucentis
    Investigational medicinal product code
    Other name
    ranibizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    0.5 mg/intravitreal injection in the study eye, administered once per month for 6 doses in total (Day 0 during the Induction Phase and Day 2 during the Maintenance Phase).

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Started
    10
    10
    22
    22
    Completed
    10
    10
    22
    20
    Not completed
    0
    0
    0
    2
         Consent withdrawn by subject
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg

    Reporting group title
    Cohort 2
    Reporting group description
    		 Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)

    Reporting group title
    Cohort 3
    Reporting group description
    		 Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)

    Reporting group title
    Cohort 4
    Reporting group description
    		 Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura & 3 doses Lucentis)

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Total
    Number of subjects
    		 10 10 22 22 64
    Age categorical
    Units: Subjects
        ≤ 18 years
    		 0 0 0 0 0
        18-64 years
    		 2 0 2 1 5
        ≥ 65 years
    		 8 10 20 21 59
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.7 ( 11.27 ) 77.9 ( 6.62 ) 74.1 ( 7.41 ) 78.1 ( 7.40 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 8 14 12 38
        Male
    		 6 2 8 10 26
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 1 1 2
        Not Hispanic or Latino
    		 10 10 21 21 62
        Unknown or Not Reported
    		 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 10 10 22 22 64
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    ETDRS Visual Acuity - Study Eye
    Units: Number of letters read
        arithmetic mean (standard deviation)
    		 53.9 ( 9.0 ) 51.5 ( 5.4 ) 52.5 ( 9.4 ) 53.2 ( 9.9 ) -

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg

    Reporting group title
    Cohort 2
    Reporting group description
    		 Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)

    Reporting group title
    Cohort 3
    Reporting group description
    		 Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)

    Reporting group title
    Cohort 4
    Reporting group description
    		 Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura & 3 doses Lucentis)

    Primary: Systemic Adverse Events

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    End point title
    		 Systemic Adverse Events [1]
    End point description
    Number of subjects with systemic treatment-emergent Adverse Events (with calculated percentage)
    End point type
    Primary
    End point timeframe
    6 months
    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: This was a safety study and no formal hypothesis testing was performed.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    10
    10
    22
    22
    Units: subjects
        all causalities (subjects)
    6
    5
    5
    11
        all causalities (%)
    60
    50
    23
    50
        related to study drugs (subjects)
    0
    0
    0
    0
        related to study drugs (%)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Ophthalmic Adverse Events

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    End point title
    		 Ophthalmic Adverse Events [2]
    End point description
    Number of subjects with ophthalmic Adverse Events (with calculated percentage)
    End point type
    Primary
    End point timeframe
    6 months
    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: This was a safety study and no formal hypothesis testing was performed.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    10
    10
    22
    22
    Units: subjects
        all causalities - study eye (subjects)
    8
    4
    11
    15
        all causalities - study eye (%)
    80
    40
    50
    68
        all causalities - fellow eye (subjects)
    1
    1
    0
    2
        all causalities - fellow eye (%)
    10
    10
    0
    9
        related to inject procedure - study eye (subjects)
    8
    4
    10
    12
        related to inject procedure - study eye (%)
    80
    40
    45
    55
        related to inject procedure - fellow eye (subject)
    0
    0
    0
    0
        related to inject procedure - fellow eye (%)
    0
    0
    0
    0
        related to study drugs - study eye (subjects)
    0
    0
    0
    0
        related to study drugs - study eye (%)
    0
    0
    0
    0
        related to study drugs - fellow eye (subjects)
    0
    0
    0
    0
        related to study drugs - fellow eye (%)
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Change from baseline - ECG

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    End point title
    		 Change from baseline - ECG
    End point description
    Number of patients with a change in ECG parameters from Baseline to Month 6
    End point type
    Other pre-specified
    End point timeframe
    6 months
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    10
    10
    22
    22
    Units: subjects
        No change (subjects)
    7
    5
    18
    12
        No change (%)
    70
    50
    82
    55
        Not Clinically Significant Change (subjects)
    3
    5
    3
    6
        Not Clinically Significant Change (%)
    30
    50
    14
    27
        Clinically Significant Change (subjects)
    0
    0
    0
    1
        Clinically Significant Change (%)
    0
    0
    0
    5
        Missing (subjects)
    0
    0
    1
    3
        Missing (%)
    0
    0
    5
    14
    No statistical analyses for this end point

    Other pre-specified: Mean Change from Baseline - Study Eye ETDRS Visual Acuity

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    End point title
    		 Mean Change from Baseline - Study Eye ETDRS Visual Acuity
    End point description
    Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.
    End point type
    Other pre-specified
    End point timeframe
    6 months
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    10
    10
    22
    22
    Units: number of letters read
        arithmetic mean (standard deviation)
    9.0 ( 11.0 )
    10.2 ( 18.7 )
    10.7 ( 10.3 )
    9.9 ( 8.2 )
    No statistical analyses for this end point

    Other pre-specified: Mean Change from Baseline - Vital Signs

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    End point title
    		 Mean Change from Baseline - Vital Signs
    End point description
    Mean change from Baseline to Month 6 in the following parameters: Pulse (beats/minute), blood pressure (mmHg), and respiration rate (breaths/minute)
    End point type
    Other pre-specified
    End point timeframe
    6 months
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    10
    10
    22
    22
    Units: units
    arithmetic mean (standard deviation)
        Pulse (beats/min)
    -5.2 ( 5.92 )
    -2.0 ( 6.77 )
    0.7 ( 11.22 )
    0.1 ( 6.75 )
        Systolic blood pressure (mmHg)
    -12.0 ( 15.04 )
    0.7 ( 8.92 )
    -1.9 ( 14.92 )
    -5.8 ( 18.24 )
        Diastolic blood pressure (mmHg)
    -3.2 ( 7.93 )
    -7.9 ( 12.32 )
    -4.7 ( 11.83 )
    -0.4 ( 8.24 )
        Respiration rate (breaths/min)
    0.6 ( 1.35 )
    -2.0 ( 3.77 )
    -1.0 ( 2.01 )
    -0.2 ( 2.31 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment until Month 6 (end of study)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 -

    Reporting group title
    Cohort 2
    Reporting group description
    		 -

    Reporting group title
    Cohort 3
    Reporting group description
    		 -

    Reporting group title
    Cohort 4
    Reporting group description
    		 -

    Serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    7 / 10 (70.00%)
    10 / 22 (45.45%)
    13 / 22 (59.09%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    1
    1
    Contusion
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Corneal abrasion
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Laceration
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    6 / 10 (60.00%)
    1 / 10 (10.00%)
    5 / 22 (22.73%)
    6 / 22 (27.27%)
         occurrences all number
    14
    1
    6
    12
    Vitreous floaters
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    3 / 22 (13.64%)
    3 / 22 (13.64%)
         occurrences all number
    0
    0
    3
    3
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 22 (4.55%)
    2 / 22 (9.09%)
         occurrences all number
    1
    1
    1
    5
    Punctate keratitis
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    1
    2
    Eye pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    3
    0
    0
    6
    Corneal oedema
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    0
    3
    Ocular discomfort
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    2
    Retinal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    2
    Vitreous detachment
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    2 / 22 (9.09%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Cataract
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Neovascular age-related macular degeneration
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Subretinal fibrosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitreous opacities
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Vitamin B complex deficiency
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    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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