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    Clinical Trial Results:
    A Randomized, Double masked, Parallel group, Dose-finding study to evaluate SYL1801 in patients with neovascular AMD

    Summary
    EudraCT number
    		 2022-000214-34
    Trial protocol
    		 SK   CZ   HU  
    Global end of trial date
    19 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2026
    First version publication date
    20 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SYL1801_II
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sylentis S.A.U
    Sponsor organisation address
    C. Progreso, 3, Getafe, Spain, 28906
    Public contact
    Clinical Trials Information, Sylentis S.A.U, 34 918047667,
    Scientific contact
    Clinical Trials Information, Sylentis S.A.U, 34 918047667,
    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
    19 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate effect on visual acuity of SYL1801 sodium at three doses (5 mg/mL, 25 mg/mL and 50 mg/mL) when administered as 1 drop once a day for 42 days in subjects with neovascular AMD.
    Protection of trial subjects
    During the treatment period, subjects will perform self-assessment of visual acuity via smartphone app. Results were reviewed by investigators' staff.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2022
    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
    Poland: 50
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Czechia: 24
    Country: Number of subjects enrolled
    Hungary: 24
    Worldwide total number of subjects
    99
    EEA total number of subjects
    99
    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)
    6
    From 65 to 84 years
    86
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were randomized in a 1:1:1 ratio to one of three treatment groups using a block randomization design

    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, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5 mg/mL SYL1801 ophthalmic solution
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SYL1801
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop q.d for 42 days

    Arm title
    		 25 mg/mL SYL1801 ophthalmic solution
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SYL1801
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop q.d for 42 days

    Arm title
    		 50 mg/mL SYL1801 ophthalmic solution
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SYL1801
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop q.d for 42 days

    Number of subjects in period 1
    		5 mg/mL SYL1801 ophthalmic solution 25 mg/mL SYL1801 ophthalmic solution 50 mg/mL SYL1801 ophthalmic solution
    Started
    35
    30
    34
    Completed
    35
    28
    34
    Not completed
    0
    2
    0
         Consent withdrawn by subject
    -
    1
    -
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group title
    25 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group title
    50 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group values
    		 5 mg/mL SYL1801 ophthalmic solution 25 mg/mL SYL1801 ophthalmic solution 50 mg/mL SYL1801 ophthalmic solution Total
    Number of subjects
    		 35 30 34 99
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 3 1 2 6
        From 65-84 years
    		 30 27 29 86
        85 years and over
    		 2 2 3 7
    Gender categorical
    Units: Subjects
        Female
    		 16 18 18 52
        Male
    		 19 12 16 47
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of the study drug and had at least one post-baseline efficacy assessment

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects in the FAS who completed the study without major protocol deviations which might affect the evaluation of the primary endpoint measures

    Subject analysis sets values
    		 FAS PP
    Number of subjects
    98
    96
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    52
    50
        Male
    46
    46

    End points

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    End points reporting groups
    Reporting group title
    5 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group title
    25 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group title
    50 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of the study drug and had at least one post-baseline efficacy assessment

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects in the FAS who completed the study without major protocol deviations which might affect the evaluation of the primary endpoint measures

    Primary: Change from baseline in BCVA score based on ETDRS visual acuity chart

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    End point title
    		 Change from baseline in BCVA score based on ETDRS visual acuity chart
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Day 42
    End point values
    		 5 mg/mL SYL1801 ophthalmic solution 25 mg/mL SYL1801 ophthalmic solution 50 mg/mL SYL1801 ophthalmic solution
    Number of subjects analysed
    35
    30
    34
    Units: letters
        least squares mean (confidence interval 95%)
    1.44 (-1.17 to 4.04)
    0.90 (-1.94 to 3.74)
    0.96 (-1.73 to 3.64)
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    5 mg/mL SYL1801 ophthalmic solution v 25 mg/mL SYL1801 ophthalmic solution v 50 mg/mL SYL1801 ophthalmic solution
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.953
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    5 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group title
    25 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Reporting group title
    50 mg/mL SYL1801 ophthalmic solution
    Reporting group description
    		 -

    Serious adverse events
    		 5 mg/mL SYL1801 ophthalmic solution 25 mg/mL SYL1801 ophthalmic solution 50 mg/mL SYL1801 ophthalmic solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 30 (6.67%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suture rupture
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 5 mg/mL SYL1801 ophthalmic solution 25 mg/mL SYL1801 ophthalmic solution 50 mg/mL SYL1801 ophthalmic solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 35 (28.57%)
    10 / 30 (33.33%)
    8 / 34 (23.53%)
    Investigations
    Blood urea increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 30 (3.33%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    Eye disorders
    Neovascular age-related macular degeneration
         subjects affected / exposed
    7 / 35 (20.00%)
    9 / 30 (30.00%)
    6 / 34 (17.65%)
         occurrences all number
    8
    10
    6
    Visual acuity reduced
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 30 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    3
    0
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Sep 2022
    Updated endpoints and scape criteria
    04 May 2023
    Updated inclusion criteria and concomitant medication clarification

    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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