Phase 3
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)
Bottom Line
View on ClinicalTrials.gov: NCT04739306 ↗Enrolled (actual)
348
Serious AEs
9.5%
Results posted
Dec 2023
Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 — 9.43; 8.85 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P42 (Biological); Eylea (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celltrion
- Primary completion
- Oct 2022
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 | — |
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
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). 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.