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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04739306
Recruitment Status : Active, not recruiting
First Posted : February 4, 2021
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema (DME) Biological: CT-P42 Biological: Eylea Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 22, 2021
Actual Primary Completion Date : June 21, 2022
Estimated Study Completion Date : April 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: CT-P42 Biological: CT-P42
2mg/0.05 mL by Intravitreal injection
Active Comparator: Eylea Biological: Eylea
2mg/0.05 mL by Intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Clinical response [ Time Frame: Week 8 ]
    Clinical response in Best Corrected Visual Acuity using Early Treatment of Diabetic Retinopathy Study chart


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739306


Locations
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Slovakia
II. Ocna klinika SZU, F.D.Roosevelt Hospital
Banska Bystrica, Slovakia
Sponsors and Collaborators
Celltrion
More Information
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04739306    
Other Study ID Numbers: CT-P42 3.1
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

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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
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases