Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema (DME)

Treatments: Biological: CT-P42; Biological: Eylea

Study type: Interventional

Funder types: Industry

Identifiers

NCT04739306

CT-P42 3.1

Details and patient eligibility

About

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

Enrollment: 348 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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348 participants in 2 patient groups

CT-P42

Experimental group

Treatment:

Biological: CT-P42

Eylea

Active Comparator group

Treatment:

Biological: Eylea