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

Diabetic Macular Edema (DME) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739306
• Other study ID #: CT-P42 3.1
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2021
• Est. completion date: April 24, 2023

Study information

• Verified date: September 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: April 24, 2023
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

Intervention

Biological:
• CT-P42
2mg/0.05 mL by Intravitreal injection
• Eylea
2mg/0.05 mL by Intravitreal injection

Locations

Country	Name	City	State
Slovakia	II. Ocna klinika SZU, F.D.Roosevelt Hospital	Banska Bystrica

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8	Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8.; Subjects with a BCVA ETDRS letter score of 73 to 34 (= Acuity of 20/40 to 20/200) in the study eye at Screening and Day 1 were included. Visual acuity of the study eye was assessed using the ETDRS charts; a higher score represents better functioning.	Baseline and Week 8
Secondary	Mean Change From Baseline in BCVA at Week 52	Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52.	Baseline and Week 52
Secondary	Proportion of Subjects Who Gained =15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52	Proportion of subjects who gained =15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time	Baseline and Week 52
Secondary	Proportion of Subjects With a =2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52	The ETDRS DRSS score was grouped into 13 severity scores based on the ETDRS Severity Level.; DR absent (level 10); Mild to moderate nonproliferative DR (levels 20, 35, and 43); Moderately severe/severe/Very Severe nonproliferative DR (levels 47, 53 and 53E); Inactive/Mild/moderate/high-risk/advanced proliferative DR (levels 60, 61, 65, 71,75, 81, and 85)	Baseline and Week 52
Secondary	Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)	The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT)	Baseline and Week 52