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

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ClinicalTrials.gov Identifier: NCT04739306
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Celltrion

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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




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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: MiSun Lee +82 32 850 5742 misun.lee@celltrion.com
Contact: ByeongHyeon Kim +82 32 850 5745 byeonghyeon.kim@celltrion.com

Locations
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Slovakia
II. Ocna klinika SZU, F.D.Roosevelt Hospital Recruiting
Banska Bystrica, Slovakia
Sponsors and Collaborators
Celltrion
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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 2, 2021
Last Verified: July 2021

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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