Status:
COMPLETED
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Lead Sponsor:
Celltrion
Conditions:
Diabetic Macular Edema (DME)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- Patient who has only one functional eye.
- Patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2023
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT04739306
Start Date
July 22 2021
End Date
April 24 2023
Last Update
December 5 2023
Active Locations (1)
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1
II. Ocna klinika SZU, F.D.Roosevelt Hospital
Banská Bystrica, Slovakia