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    Clinical Trial Results:
    A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema

    Summary
    EudraCT number
    		 2017-004358-40
    Trial protocol
    		 LV   HU  
    Global end of trial date
    10 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Sep 2022
    First version publication date
    20 Sep 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MYL-1701P-3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03610646
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mylan Pharmaceuticals Inc.
    Sponsor organisation address
    1000 Mylan Blvd, Canonsburg, PA, United States, 15317
    Public contact
    Rajesh Suresh Nachankar, Ph D, Mylan Pharmaceuticals Inc., +91 9148448205, rajesh.nachankar@viatris.com
    Scientific contact
    Prasanna Ganapathi, MD, Mylan Pharmaceuticals Inc., +91 80 6672 8000, prasannac.ganapathi@viatris.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
    23 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the clinical equivalence of MYL-1701P and Eylea over 8 weeks of treatment at doses and regimen recommended by the Prescribing Information for Eylea, as assessed by change from baseline to week 8 in best corrected visual acuity (BCVA).
    Protection of trial subjects
    The study was conducted in compliance with regulatory requirements, the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and with the ethical principles of the Declaration of Helsinki. All laboratory specimens, evaluation forms, reports, and other records were identified in a manner designed to maintain patient confidentiality. All records were kept in a secure storage area with limited access. Clinical information was not to be released without the written permission of the patient (or the patient’s legal guardian), except as necessary for monitoring and auditing by the sponsor, its designee, regulatory authorities or the IRB/IEC. The PI (or designee) and all employees and coworkers involved with this study have not disclosed or used for any purpose other than performance of the study any data, record, or other unpublished, confidential information disclosed to those individuals for the purpose of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 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
    Poland: 37
    Country: Number of subjects enrolled
    Czechia: 43
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Hungary: 52
    Country: Number of subjects enrolled
    Latvia: 18
    Country: Number of subjects enrolled
    India: 77
    Country: Number of subjects enrolled
    Japan: 41
    Country: Number of subjects enrolled
    United States: 63
    Country: Number of subjects enrolled
    Russian Federation: 13
    Worldwide total number of subjects
    355
    EEA total number of subjects
    161
    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)
    207
    From 65 to 84 years
    148
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included male or female patients of 18 years or older, who suffered from Diabetic Macular Oedema (DME). Between 27-Jul-2015 and 15-Sep-20, 639 (unique) patients were screened and 355 patients were randomized in sites in 9 countries in Europe (Czech R., Germany, Hungary, Latvia and Poland), USA, Russia, Japan and India.

    Pre-assignment
    Screening details
    		 A total of 639 (unique) subjects were screened; total 673 screenings due to 34 rescreenings. 318 subjects were screen failures and 355 patients were randomized.

    Period 1
    Period 1 title
    Study Treatment (Week 52) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    This was a double-masked study. Patient and the investigator(s) who performed safety and efficacy evaluations were masked to study treatment. In each site, there were masked staff members (responsible all study assessments) and unmasked injecting physician (responsible for the injections). In case unmasked injecting physician was unavailable, unmasked pharmacist prepared the injections and handed over injections in the masked form to a masked physician for injection.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MYL-1701P
    Arm description
    		 Subjects to receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Proposed Aflibercept Biosimilar
    Investigational medicinal product code
    MYL-1701P
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    MYL-1701P (a proposed biosimilar to Eylea) injection for intravitreal injection is a sterile, preservative-free, aqueous solution in a single-use, glass vial designed to deliver 0.05 mL (50 μL) of proposed aflibercept (40 mg/mL). All subjects were planned to receive study drug as an intravitreal injection at a dose of 2 mg every 4 weeks for a total of 5 injections, and then every 8 weeks through the remainder of the 52-week treatment period, with the last dose at 48 weeks. In addition to the nine planned doses, study drug may also be administered at Week 20, Week 28, Week 36 and Week 44 based on protocol defined criteria.

    Arm title
    		 Eylea
    Arm description
    		 Subjects to receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eylea
    Investigational medicinal product code
    Other name
    Aflibercept
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    50 uL injection (40 mg/ml)

    Number of subjects in period 1
    		MYL-1701P Eylea
    Started
    179
    176
    Completed
    161
    158
    Not completed
    18
    18
         Adverse event, serious fatal
    2
    3
         Consent withdrawn by subject
    8
    9
         Physician decision
    2
    -
         Adverse event, non-fatal
    5
    4
         Non-compliance
    1
    -
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MYL-1701P
    Reporting group description
    		 Subjects to receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

    Reporting group title
    Eylea
    Reporting group description
    		 Subjects to receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

    Reporting group values
    		 MYL-1701P Eylea Total
    Number of subjects
    		 179 176 355
    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)
    		 101 106 207
        From 65-84 years
    		 78 70 148
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.8 ± 8.37 61.6 ± 9.93 -
    Gender categorical
    Units: Subjects
        Female
    		 72 67 139
        Male
    		 107 109 216
    Subject analysis sets

    Subject analysis set title
    Intent to Treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to-treat (ITT) analysis set consists of all randomized subjects.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set consists of all subjects who received at least one dose of study drug.

    Subject analysis sets values
    		 Intent to Treat Safety analysis set
    Number of subjects
    355
    354
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    207
    206
        From 65-84 years
    148
    148
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.2 ± 9.18
    ±
    Gender categorical
    Units: Subjects
        Female
    139
        Male
    216

    End points

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    End points reporting groups
    Reporting group title
    MYL-1701P
    Reporting group description
    		 Subjects to receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

    Reporting group title
    Eylea
    Reporting group description
    		 Subjects to receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

    Subject analysis set title
    Intent to Treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to-treat (ITT) analysis set consists of all randomized subjects.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set consists of all subjects who received at least one dose of study drug.

    Primary: Mean Change From Baseline in Best Corrected Visual Acuity (letters) at Week 8

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    End point title
    		 Mean Change From Baseline in Best Corrected Visual Acuity (letters) at Week 8
    End point description
    The primary endpoint was the mean change from baseline in Best Corrected Visual Acuity (BCVA) letters after 8 weeks of treatment. All patients included in the intent to treat (all randomized) were analysed. BCVA is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
    End point type
    Primary
    End point timeframe
    Baseline to week 8
    End point values
    		 MYL-1701P Eylea
    Number of subjects analysed
    179
    176
    Units: BCVA Letter Score
        least squares mean (standard error)
    6.60 ± 0.548
    6.56 ± 0.548
    Statistical analysis title
    		 Comparison of change in BCVA [letters] at week 8
    Statistical analysis description
    Mixed model for repeated measures analysis
    Comparison groups
    MYL-1701P v Eylea
    Number of subjects included in analysis
    355
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.73
    Notes
    [1] - If the 95% CI was contained in the interval of -3.0 to +3.0 letters, equivalence of MYL-1701P and Eylea could be established.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to week 52- Adverse Events were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported for all patients from start of treatment till End of study Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    MYL-1701P
    Reporting group description
    		 -

    Reporting group title
    Eylea
    Reporting group description
    		 -

    Serious adverse events
    		 MYL-1701P Eylea
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 178 (17.42%)
    23 / 176 (13.07%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    2
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 178 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood potassium increased
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac fibrillation
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 178 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Brain stem infarction
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Endolymphatic hydrops
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Corneal oedema
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous detachment
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal incontinence
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 178 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    2 / 178 (1.12%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Neuropathic arthropathy
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (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
    Atypical pneumonia
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 178 (1.69%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 178 (1.12%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 176 (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
    		 MYL-1701P Eylea
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 178 (29.78%)
    61 / 176 (34.66%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    16 / 178 (8.99%)
    20 / 176 (11.36%)
         occurrences all number
    20
    23
    Eye disorders
    Cataract
         subjects affected / exposed
    12 / 178 (6.74%)
    12 / 176 (6.82%)
         occurrences all number
    17
    12
    Diabetic retinal oedema
         subjects affected / exposed
    9 / 178 (5.06%)
    10 / 176 (5.68%)
         occurrences all number
    9
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 178 (7.87%)
    10 / 176 (5.68%)
         occurrences all number
    19
    10
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 178 (1.12%)
    9 / 176 (5.11%)
         occurrences all number
    3
    10

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jun 2020
    1) Addition of subjects due to the potential impact related to COVID-19 pandemic. 2) Exclusion criteria Subjects with history of use of intraocular or periocular corticosteroids. 3) Collect smoking history 4) Added text to clarify visit window. 5)All other country specific amendments (applicable for respective country) added in this version 6) Contingency measures implemented due to COVID-19 in Clinical Study Report 7) Added instructions to the investigators to manage COVID-19 pandemic.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Mar 2020
    Except Japan, in all other countries temporary hold on recruitment (Local situation) to reduce risk of exposure to COVID-19.
    28 May 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Not applicable.
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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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