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    Clinical Trial Results:
    A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison with Eylea in Patients with Diabetic Macular Edema

    Summary
    EudraCT number
    		 2020-004278-23
    Trial protocol
    		 DE   SK   HU   CZ   PL   LT   LV  
    Global end of trial date
    18 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2024
    First version publication date
    08 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P42_3.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04739306
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celltrion, Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014
    Public contact
    Keum Young Ahn, CELLTRION Inc., 82 328504190, KeumYoung.Ahn@celltrion.com
    Scientific contact
    Keum Young Ahn, CELLTRION Inc., 82 328504190, KeumYoung.Ahn@celltrion.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 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that CT-P42 is similar to Eylea in terms of efficacy as determined by clinical response according to the mean change from baseline at Week 8 in Best Corrected Visual Acuity (BCVA) using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
    Protection of trial subjects
    The clinical study protocol, protocol amendments, informed consent forms (ICFs), and any other appropriate study-related documents were reviewed and approved by independent ethics committees (IECs) and institutional review boards (IRBs) before implementation. This study was conducted in accordance with the accepted version of the Declaration of Helsinki and/or all relevant regulations, in compliance with International Council for Harmonisation (ICH) E6 (R2): good clinical practice (GCP) guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted. Before entering the study, the investigator (or designee) explained to each patient (or his/her legally acceptable guardian, if applicable) the nature of the study, its purpose, procedures, expected duration, alternative therapy available, and the benefits and risks involved in study participation. The patients were given adequate time and opportunity to read and understand the information and ask any questions
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jul 2021
    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
    Czechia: 37
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    Hungary: 41
    Country: Number of subjects enrolled
    India: 104
    Country: Number of subjects enrolled
    Latvia: 14
    Country: Number of subjects enrolled
    Lithuania: 1
    Country: Number of subjects enrolled
    Poland: 40
    Country: Number of subjects enrolled
    Korea, Republic of: 20
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Slovakia: 47
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    Ukraine: 11
    Worldwide total number of subjects
    348
    EEA total number of subjects
    199
    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)
    196
    From 65 to 84 years
    150
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient assigned to treatment date was on 22 July 2021. This study was conducted at 83 study centers in Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, Russia, Slovakia, Spain, Ukraine, Republic of Korea, and India. In these study centers, 484 patients were screened and 348 patients were enrolled in this study.

    Pre-assignment
    Screening details
    		 Patients with a diagnosis of either type 1 or 2 diabetes mellitus (DM) with DME involving the center of the macula were enrolled in the study if they had met all of the inclusion criteria and none of the exclusion criteria.

    Period 1
    Period 1 title
    Main Study Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The study will be conducted in a double-masked manner during the Main Study Period. The randomization codes for the Main Study Period will not be revealed to study patients, investigators, and study center personnel until the final CSR has been generated except for predefined unmasked personnel from Sponsor and CRO.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P42
    Arm description
    		 Subjects were randomly assigned to CT-P42 group (2mg/0.05 mL) to administer by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P42
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2mg/0.05 mL of CT-P42 administrated by intravitreal injection via a single-dose vial

    Arm title
    		 Eylea
    Arm description
    		 Subjects were randomly assigned to Eylea group (2mg/0.05 mL) to administer by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eylea
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2mg/0.05 mL of Eylea administrated by intravitreal injection via a single-dose vial

    Number of subjects in period 1
    		CT-P42 Eylea
    Started
    173
    175
    Completed
    153
    153
    Not completed
    20
    22
         Adverse event, serious fatal
    3
    2
         Physician decision
    1
    1
         Consent withdrawn by subject
    8
    6
         Adverse event, non-fatal
    3
    5
         Lost to follow-up
    4
    6
         War in Ukraine
    1
    1
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Extension Study Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    After the Main Study period, a total of 31 subjects, regardless of the treatment group in Main Study Period, were enrolled in a 4-week open-label, single-arm Extension study.

    Arms
    Arm title
    		 CT-P42 (Extension Study Period)
    Arm description
    		 Subjects were enrolled in the extension study to administer 2 mg/0.05mL of CT-P42 by pre-filled syringe IVT injection at Extension Week 0 (1 dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P42 PFS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravitreal use
    Dosage and administration details
    2 mg/0.05mL of CT-P42 by intravitreal injection via a single-dose pre-filled syringe

    Number of subjects in period 2 [1]
    		CT-P42 (Extension Study Period)
    Started
    31
    Completed
    31
    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: After the Main Study period, a total of 31 subjects, regardless of the treatment group in Main Study Period, were enrolled in a 4-week open-label, single-arm Extension study. It was planned to enroll 30 patients for extension study period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P42
    Reporting group description
    		 Subjects were randomly assigned to CT-P42 group (2mg/0.05 mL) to administer by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses

    Reporting group title
    Eylea
    Reporting group description
    		 Subjects were randomly assigned to Eylea group (2mg/0.05 mL) to administer by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses

    Reporting group values
    		 CT-P42 Eylea Total
    Number of subjects
    		 173 175 348
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 101 95 196
        From 65-84 years
    		 71 79 150
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.5 ( 9.6 ) 62.9 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 67 78 145
        Male
    		 106 97 203
    BCVA at Baseline
    Baseline visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 34 (= Acuity of 20/40 to 20/200) in the study eye were included; a higher score represents better functioning.
    Units: Letters
        arithmetic mean (standard deviation)
    		 60.3 ( 9.7 ) 60.4 ( 10.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    CT-P42
    Reporting group description
    		 Subjects were randomly assigned to CT-P42 group (2mg/0.05 mL) to administer by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses

    Reporting group title
    Eylea
    Reporting group description
    		 Subjects were randomly assigned to Eylea group (2mg/0.05 mL) to administer by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses
    Reporting group title
    CT-P42 (Extension Study Period)
    Reporting group description
    		 Subjects were enrolled in the extension study to administer 2 mg/0.05mL of CT-P42 by pre-filled syringe IVT injection at Extension Week 0 (1 dose).

    Primary: Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8

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    End point title
    		 Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8
    End point description
    Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Subjects with a BCVA ETDRS letter score of 73 to 34 (= Acuity of 20/40 to 20/200) in the study eye at Screening and Day 1 were included. Visual acuity of the study eye was assessed using the ETDRS charts; a higher score represents better functioning. An analysis of covariance (ANCOVA) was performed for study eye with change from baseline in BCVA at Week 8 as dependent variable, treatment as a factor, and baseline BCVA and country as covariates. Least squares means and standard errors were calculated from the ANCOVA model.
    End point type
    Primary
    End point timeframe
    Baseline and Week 8
    End point values
    		 CT-P42 Eylea
    Number of subjects analysed
    169
    172
    Units: Letters
        least squares mean (standard error)
    9.43 ( 0.798 )
    8.85 ( 0.775 )
    Statistical analysis title
    		 Primary efficacy: Estimate of treatment difference
    Statistical analysis description
    The FAS was defined as all patients who were randomly assigned and received at least 1 full dose of study drug during the Main Study Period. The FAS was the primary analysis set for efficacy endpoint analyses. The analysis was conducted by analysis of covariance (ANCOVA) for study eye. The ANCOVA model included the change from baseline in BCVA as the dependent variable, treatment as a factor, baseline BCVA and country as covariates.
    Comparison groups
    CT-P42 v Eylea
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 1.88
    Variability estimate
    Standard error of the mean

    Secondary: Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 52

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    End point title
    		 Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 52
    End point description
    Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 CT-P42 Eylea
    Number of subjects analysed
    156
    156
    Units: Letters
        arithmetic mean (standard deviation)
    12.1 ( 8.9 )
    11.1 ( 9.9 )
    No statistical analyses for this end point

    Secondary: Proportion of subjects who gained ≥15 letters from baseline in BCVA as Measured by ETDRS Letter Score Compared with baseline at Week 52

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    End point title
    		 Proportion of subjects who gained ≥15 letters from baseline in BCVA as Measured by ETDRS Letter Score Compared with baseline at Week 52
    End point description
    Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 CT-P42 Eylea
    Number of subjects analysed
    173
    175
    Units: Participants
    60
    52
    No statistical analyses for this end point

    Secondary: Proportion of subjects with ≥2-step Improvement from baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Scale) score as Assessed by FP (Fundus Photography) at Week 52

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    End point title
    		 Proportion of subjects with ≥2-step Improvement from baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Scale) score as Assessed by FP (Fundus Photography) at Week 52
    End point description
    The ETDRS DRSS score was grouped into 13 severity scores based on the ETDRS Severity Level. DR absent (level 10); Mild to moderate nonproliferative DR (levels 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53 ); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71, 75, 81, and 85). Levels 12, 14, 15 and 53E are not considered separate steps in the scale, but are pooled with level 10, 20, 20 and 53, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 CT-P42 Eylea
    Number of subjects analysed
    173
    175
    Units: Participants
    41
    38
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)

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    End point title
    		 Mean change from baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)
    End point description
    The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT)
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 CT-P42 Eylea
    Number of subjects analysed
    151
    154
    Units: micrometer
        arithmetic mean (standard deviation)
    -220.7 ( 147.1 )
    -191.2 ( 137.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
    Adverse event reporting additional description
    Safety analyses were performed in the Safety set and was pre-specified to only report the most severe event if one or more events were occurred to the same subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    CT-P42 (Main Study Period)
    Reporting group description
    		 The safety set for Main Study Period was defined as all randomly assigned patients who received at least 1 full or partial dose of CT-P42 (2mg/0.05mL) regardless of the randomized treatment groups in the Main Study Period. The safety set for Main Study Period was the primary analysis set for the summary of safety data.

    Reporting group title
    Eylea (Main Study Period)
    Reporting group description
    		 The safety set for Main Study Period was defined as all randomly assigned patients who received at least 1 full or partial dose of Eylea (2mg/0.05mL) and did not receive CT-P42 during the Main Study Period. The safety set for Main Study Period was the primary analysis set for the summary of safety data.

    Reporting group title
    CT-P42 (Extension Study Period)
    Reporting group description
    		 The Safety set for Extension Study Period was defined as all patients who receive a full or partial dose of study drug in the Extension Study Period. The Safety set for Extension Study Period was used for the analyses of all safety and efficacy data collected on or after Extension Week 0. Subjects were administrated 2 mg/0.05mL of CT-P42 by intravitreal injection via a single-dose at Extension Week 0 (1 dose).

    Serious adverse events
    		 CT-P42 (Main Study Period) Eylea (Main Study Period) CT-P42 (Extension Study Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 174 (10.92%)
    17 / 174 (9.77%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    3
    2
    0
         number of deaths resulting from adverse events
    3
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Renal cancer
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Dry gangrene
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular occlusion
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 174 (0.00%)
    2 / 174 (1.15%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Atrial fibrillation
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 174 (0.57%)
    1 / 174 (0.57%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 174 (0.57%)
    2 / 174 (1.15%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Myocardial infarction
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Cerebral infarction
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Ischaemic stroke
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Deficiency anaemia
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Umbilical hernia
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    2 / 174 (1.15%)
    0 / 174 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Diabetic foot
         subjects affected / exposed
    2 / 174 (1.15%)
    1 / 174 (0.57%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    0 / 174 (0.00%)
    2 / 174 (1.15%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Musculoskeletal and connective tissue disorders
    Vertebral end plate inflammation
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Carbuncle
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Cellulitis
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Device related infection
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Diabetic gangrene
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Emphysematous pyelonephritis
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Pneumonia
         subjects affected / exposed
    1 / 174 (0.57%)
    1 / 174 (0.57%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 31 (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
    Hyponatraemia
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 31 (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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 CT-P42 (Main Study Period) Eylea (Main Study Period) CT-P42 (Extension Study Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 174 (36.78%)
    71 / 174 (40.80%)
    3 / 31 (9.68%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 174 (0.00%)
    5 / 174 (2.87%)
    1 / 31 (3.23%)
         occurrences all number
    0
    5
    1
    Intraocular pressure increased
         subjects affected / exposed
    3 / 174 (1.72%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    5
    9
    0
    Intraocular pressure increased-Study eye
    Additional description: Study eye
         subjects affected / exposed
    3 / 174 (1.72%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    5
    8
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 174 (6.32%)
    16 / 174 (9.20%)
    0 / 31 (0.00%)
         occurrences all number
    12
    17
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    6 / 174 (3.45%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    6
    4
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    2 / 174 (1.15%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    2
    5
    0
    Conjunctival haemorrhage-Study eye
    Additional description: Study eye
         subjects affected / exposed
    2 / 174 (1.15%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    2
    5
    0
    Diabetic retinal oedema
         subjects affected / exposed
    17 / 174 (9.77%)
    23 / 174 (13.22%)
    1 / 31 (3.23%)
         occurrences all number
    18
    26
    1
    Posterior capsule opacification
         subjects affected / exposed
    4 / 174 (2.30%)
    3 / 174 (1.72%)
    0 / 31 (0.00%)
         occurrences all number
    5
    3
    0
    Visual acuity reduced
         subjects affected / exposed
    5 / 174 (2.87%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    5
    4
    0
    Vitreous floaters
         subjects affected / exposed
    3 / 174 (1.72%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    3
    4
    0
    Vitreous haemorrhage
         subjects affected / exposed
    4 / 174 (2.30%)
    0 / 174 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    5
    0
    0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    5 / 174 (2.87%)
    0 / 174 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    5
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 174 (4.60%)
    10 / 174 (5.75%)
    0 / 31 (0.00%)
         occurrences all number
    8
    10
    0
    Influenza
         subjects affected / exposed
    1 / 174 (0.57%)
    6 / 174 (3.45%)
    1 / 31 (3.23%)
         occurrences all number
    1
    7
    1
    Nasopharyngitis
         subjects affected / exposed
    9 / 174 (5.17%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    11
    5
    0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    7 / 174 (4.02%)
    7 / 174 (4.02%)
    0 / 31 (0.00%)
         occurrences all number
    7
    7
    0
    Dyslipidaemia
         subjects affected / exposed
    1 / 174 (0.57%)
    4 / 174 (2.30%)
    0 / 31 (0.00%)
         occurrences all number
    1
    4
    0
    Hyperkalaemia
         subjects affected / exposed
    4 / 174 (2.30%)
    5 / 174 (2.87%)
    0 / 31 (0.00%)
         occurrences all number
    4
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2021
    -Updated sponsor contact information. -Changed the reference drug from US licensed Eylea to EU approved Eylea. -Added test items for immunogenicity assessment. -Updated the number of study centers and countries. -Added detailed definition for a woman of childbearing potential -Added new conditions for temporary interruption of the study drug. -Added specific time point of SD-OCT assessment.
    14 Jan 2022
    -Updated the target number of patients to reflect changes in study plan. -Deleted condition of axial length considering current clinical practice. -Added description to reflect change in the EOS visit plan. -Blood sampling time points for Pharmacokinetic were reduced due to operational reason. -Updated the total number of patients and statistical assumptions for the sample size to reflect changes in study plan. -Updated the version of PASS software. -Revised to add more details about analysis plan. -Added phrase to reflect change in the EOS visit plan in order to reduce missing data for primary endpoint at Week8. -Added to describe EOS visit plan in details in order to reduce missing data for primary endpoint at Week8. -Updated as per pharmacy manual. -Updated plan for FA image acquisition at screening. -Added to provides detailed operation plan for DSMB. -Updated to allow longer window for Week 1 visit.
    12 Apr 2022
    -Treatment Period and EOS visit are retitled. -Extension Study Period and information of CT-P42 pre-filled syringe is newly added. -Study design for Extension Study Period is added in details. -Study design for Extension Study Period and 2nd EOS visit is added in details. -Assessment time points are added for the Extension Study Period. -CT-P42 PFS usability assessment is added. -Analysis sets are retitled and new analysis sets are added for Extension Study Period. -Added usability assessment checklist for PFS.

    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.
    Due to the global impact of the COVID-19 pandemic, the Sponsor took proactive measures for the safety of participants. Due to the war in Ukraine during the study, increase in protocol deviations was unavoidable and some procedures were changed.
    For support, Contact us.
    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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