Back to resultsStudy to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema (DME)
Status
Completed
Phase
Phase 3
Locations
Slovakia
Study Type
Interventional
Intervention
CT-P42
Eylea
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema (DME)
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
Sites / Locations
- II. Ocna klinika SZU, F.D.Roosevelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT-P42
Eylea
Arm Description
Outcomes
Primary Outcome Measures
Clinical response
Clinical response in Best Corrected Visual Acuity using Early Treatment of Diabetic Retinopathy Study chart
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04739306
Brief Title
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
April 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema (DME)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
348 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P42
Arm Type
Experimental
Arm Title
Eylea
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
CT-P42
Intervention Description
2mg/0.05 mL by Intravitreal injection
Intervention Type
Biological
Intervention Name(s)
Eylea
Intervention Description
2mg/0.05 mL by Intravitreal injection
Primary Outcome Measure Information:
Title
Clinical response
Description
Clinical response in Best Corrected Visual Acuity using Early Treatment of Diabetic Retinopathy Study chart
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
II. Ocna klinika SZU, F.D.Roosevelt Hospital
City
Banska Bystrica
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
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