Phase 3
Completed N=348
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Diabetic Macular Edema (DME)
Source: ClinicalTrials.gov NCT04739306 ↗
Enrolled (actual)
348
Serious AEs
9.5%
Results posted
Dec 2023
Primary outcomePrimary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 — 9.43; 8.85 letters
◆ Published Evidence
Not yet cited
0citations
Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial.
Summary
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
Linked Publications
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Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 |
9.43; 8.85 | — |
| SECONDARY Mean Change From Baseline in BCVA at Week 52 |
12.1; 11.1 | — |
| SECONDARY Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 |
60; 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 |
41; 38 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT) |
-220.7; -191.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patient aged ≥18 years.
- Patient with DME secondary to DM involving the center of the macula (defined as the Optical Coherence Tomography [OCT] central subfield) in the study eye.
Exclusion Criteria
- Patient who has only one functional eye.
- Patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy
Data sourced from ClinicalTrials.gov (NCT04739306) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.