Trial · NCT04739306
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
NCT04739306, Phase 3, Completed, Celltrion; results first posted 2023-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema. Trials, record NCT04739306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04739306
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
- NCT number
- NCT04739306
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 348 participants, actual
- Lead sponsor
- Celltrion
- Conditions
- Diabetic Macular Edema (DME)
- Interventions
- CT-P42, Eylea
- First posted
- 2021-02-04
- Last updated
- 2023-12-05
- Results first posted
- 2023-12-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | Baseline and 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. |
| Secondary | Mean Change From Baseline in BCVA at Week 52 | Baseline and Week 52 | Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52. |
| Secondary | Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 | Baseline and Week 52 | Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time |
| 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 | Baseline and 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) |
| Secondary | Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) | Baseline and Week 52 | The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | Baseline and Week 8 | 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. | letters | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in BCVA at Week 52 | Baseline and Week 52 | Full analysis set (subjects analysed at Week 52). Missing data were not imputed unless methods for handling missing data are specified. | letters | MEAN |
| SECONDARY | Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 | Baseline and Week 52 | Full analysis set. Missing data were not imputed unless methods for handling missing data are specified. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Baseline and Week 52 | Full analysis set. Missing data were not imputed unless methods for handling missing data are specified. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) | Baseline and Week 52 | Full analysis set (subjects analysed at Week 52). Missing data were not imputed unless methods for handling missing data are specified. | micrometer | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | CT-P42 | 9.43 | Standard Error 0.798 | letters | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | Eylea | 8.85 | Standard Error 0.775 | letters | |
| Mean Change From Baseline in BCVA at Week 52 | CT-P42 | 12.1 | Standard Deviation 8.9 | letters | |
| Mean Change From Baseline in BCVA at Week 52 | Eylea | 11.1 | Standard Deviation 9.9 | letters | |
| Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 | CT-P42 | 60 | Participants | ||
| Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 | Eylea | 52 | Participants | ||
| 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 | CT-P42 | 41 | Participants | ||
| 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 | Eylea | 38 | Participants | ||
| Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) | CT-P42 | -220.7 | Standard Deviation 147.1 | micrometer | |
| Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) | Eylea | -191.2 | Standard Deviation 137.0 | micrometer |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study Period | STARTED | CT-P42 (Main Study Period) | 173 | |
| Main Study Period | STARTED | Eylea (Main Study Period) | 175 | |
| Main Study Period | COMPLETED | CT-P42 (Main Study Period) | 153 | |
| Main Study Period | COMPLETED | Eylea (Main Study Period) | 153 | |
| Main Study Period | NOT COMPLETED | CT-P42 (Main Study Period) | 20 | |
| Main Study Period | NOT COMPLETED | Eylea (Main Study Period) | 22 | |
| CT-P42 PFS (Extension Study Period) | STARTED | CT-P42 (Main Study Period) | 15 | |
| CT-P42 PFS (Extension Study Period) | STARTED | Eylea (Main Study Period) | 16 | |
| CT-P42 PFS (Extension Study Period) | COMPLETED | CT-P42 (Main Study Period) | 15 | |
| CT-P42 PFS (Extension Study Period) | COMPLETED | Eylea (Main Study Period) | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | CT-P42 (Main Study Period) | 6 | 174 | 6 |
| other | Cataract | Eye disorders | Eylea (Main Study Period) | 4 | 174 | 4 |
| other | Cataract | Eye disorders | CT-P42 (Extension Study Period) | 0 | 31 | 0 |
| other | Conjunctival haemorrhage | Eye disorders | CT-P42 (Main Study Period) | 2 | 174 | 2 |
| other | Conjunctival haemorrhage | Eye disorders | Eylea (Main Study Period) | 4 | 174 | 5 |
| other | Conjunctival haemorrhage | Eye disorders | CT-P42 (Extension Study Period) | 0 | 31 | 0 |
| other | Conjunctival haemorrhage | Eye disorders | CT-P42 (Main Study Period) | 2 | 174 | 2 |
| other | Conjunctival haemorrhage | Eye disorders | Eylea (Main Study Period) | 4 | 174 | 5 |
| other | Conjunctival haemorrhage | Eye disorders | CT-P42 (Extension Study Period) | 0 | 31 | 0 |
| other | Diabetic retinal oedema | Eye disorders | CT-P42 (Main Study Period) | 17 | 174 | 18 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT-P42 (Main Study Period) | 3 | 174 |
| Total, all-cause mortality | Eylea (Main Study Period) | 2 | 174 |
| Total, all-cause mortality | CT-P42 (Extension Study Period) | 0 | 31 |
| Total, other adverse events | CT-P42 (Main Study Period) | 64 | 174 |
| Total, other adverse events | Eylea (Main Study Period) | 71 | 174 |
| Total, other adverse events | CT-P42 (Extension Study Period) | 3 | 31 |
| Total, serious adverse events | CT-P42 (Main Study Period) | 19 | 174 |
| Total, serious adverse events | Eylea (Main Study Period) | 17 | 174 |
| Total, serious adverse events | CT-P42 (Extension Study Period) | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40879891 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CT-P42 vs Eylea: 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 | Trial comparisons |
| CT-P42 vs Eylea: Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04739306
GET https://conductscience.org/api/trials/v1/NCT04739306/events?page=2