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This is 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P42 | Experimental |
| |
| Eylea | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P42 | Biological | 2mg/0.05 mL by Intravitreal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | 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. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in BCVA at Week 52 | Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52. | Baseline and Week 52 |
| Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II. Ocna klinika SZU, F.D.Roosevelt Hospital | Banská Bystrica | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40879891 | Derived | Brown DM, Wolf S, Veselovsky M, Veith M, Papp A, Mange S, Mondal LK, Romanczak D, Janco L, Chauhan R, Romanowska-Dixon B, Eremina A, Dusova J, Sagong M, Kim S, Bae Y, Kim S, Bae Y, Son D, Kang H, Choi S, Stanga PE. Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. Ophthalmol Ther. 2025 Nov;14(11):2769-2783. doi: 10.1007/s40123-025-01197-w. Epub 2025 Aug 29. |
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Subjects who were randomly assigned to either group administrated study drug by intravitreal injection (IVT) via a sigle-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
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. The subjects were administrated 2 mg/0.05mL of CT-P42 by pre-filled syringe IVT injection at Extension Week 0 (1 dose).
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P42 (Main Study Period) | Subjects who were randomly assigned to CT-P42 group (2mg/0.05 mL) administrated by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48. |
| FG001 | Eylea (Main Study Period) | Subjects who were randomly assigned to Eylea group (2mg/0.05 mL) administrated by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study Period |
|
| |||||||||||||||||||||
| CT-P42 PFS (Extension Study Period) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P42 | CT-P42: 2mg/0.05 mL by Intravitreal injection |
| BG001 | Eylea | Eylea: 2mg/0.05 mL by Intravitreal injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | 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. | Full analysis set (FAS) consists of all subjects who are randomly assigned and received at least 1 full dose of study drug during the Main Study Period. Missing data were not imputed unless methods for handling missing data are specified. | Posted | Least Squares Mean | Standard Error | letters | Baseline and Week 8 |
|
Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject.
Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P42 (Main Study Period) | Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning | CELLTRION, Inc. | +82-32-850-4190 | keumyoung.ahn@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2022 | Oct 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2023 | Oct 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Eylea |
| Biological |
2mg/0.05 mL by Intravitreal injection |
|
Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time |
| Baseline and Week 52 |
| Proportion of Subjects With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 | 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/Very Severe nonproliferative DR (levels 47, 53 and 53E); Inactive/Mild/moderate/high-risk/advanced proliferative DR (levels 60, 61, 65, 71,75, 81, and 85) | Baseline and Week 52 |
| Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) | The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) | Baseline and Week 52 |
| Physician Decision |
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| Withdrawal by Subject |
|
| Protocol Violation |
|
| War in Ukraine |
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| NOT COMPLETED |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BCVA score 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. | Mean | Standard Deviation | letters |
|
| OG001 | Eylea | Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48. |
|
|
|
| Secondary | Mean Change From Baseline in BCVA at Week 52 | Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52. | Full analysis set (subjects analysed at Week 52). Missing data were not imputed unless methods for handling missing data are specified. | Posted | Mean | Standard Deviation | letters | Baseline and Week 52 |
|
|
|
| Secondary | Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 | Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time | Full analysis set. Missing data were not imputed unless methods for handling missing data are specified. | Posted | Count of Participants | Participants | Baseline and Week 52 |
|
|
|
| Secondary | Proportion of Subjects With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 | 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/Very Severe nonproliferative DR (levels 47, 53 and 53E); Inactive/Mild/moderate/high-risk/advanced proliferative DR (levels 60, 61, 65, 71,75, 81, and 85) | Full analysis set. Missing data were not imputed unless methods for handling missing data are specified. | Posted | Count of Participants | Participants | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) | The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) | Full analysis set (subjects analysed at Week 52). Missing data were not imputed unless methods for handling missing data are specified. | Posted | Mean | Standard Deviation | micrometer | Baseline and Week 52 |
|
|
|
| 3 |
| 174 |
| 19 |
| 174 |
| 64 |
| 174 |
| EG001 | Eylea (Main Study Period) | Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48. | 2 | 174 | 17 | 174 | 71 | 174 |
| EG002 | CT-P42 (Extension Study Period) | Subjects were administrated 2 mg/0.05mL of CT-P42 by intravitreal injection via a single-dose pre-filled syringe at Extension Week 0 (1 dose). | 0 | 31 | 0 | 31 | 3 | 31 |
| Aortic valve stenosis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Carbuncle | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Diabetic gangrene | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Emphysematous pyelonephritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Vertebral end plate inflammation | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Dry gangrene | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Vascular occlusion | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 25.1 | Systematic Assessment | Study eye |
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| Diabetic retinal oedema | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA 25.1 | Systematic Assessment | Study eye |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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