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

• Sponsor: Celltrion (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04739306
• Collaborator: (none)
• Enrollment: 348
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.1
• Patients Per Site Per Month: 16.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema (DME)	Biological: CT-P42; Biological: Eylea	Phase 3

Study Design

• Study Type: Interventional
• 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: Jul 22, 2021
• Actual Primary Completion Date: Jun 21, 2022
• Anticipated Study Completion Date: Apr 25, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Clinical response [Week 8]

   Clinical response in Best Corrected Visual Acuity using Early Treatment of Diabetic Retinopathy Study chart

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	II. Ocna klinika SZU, F.D.Roosevelt Hospital	Banska Bystrica		Slovakia

Sponsors and Collaborators

• Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT04739306
• Other Study ID Numbers: CT-P42 3.1
• First Posted: Feb 4, 2021
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• 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: Macular Edema; Edema

Study Results

No Results Posted as of Aug 22, 2022