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

Phase 3

Completed

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Biological: CT-P42; Biological: Eylea

• Registration Number: NCT04739306
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Study Start: 2021-07-22
• Primary Completion: 2022-10-14
• Study Completion: 2023-04-24
• Status Verified: 2023-09
• Results First Submitted: 2023-10-18
• Results First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Results First Posted: 2023-12-05
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P42	CT-P42	-
Eylea	Eylea	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in BCVA at Week 52	Baseline and Week 52	Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52.
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	Baseline and 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)
Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52	Baseline and Week 52	Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)	Baseline and Week 52	The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT)

Trial Locations

Locations (1)

II. Ocna klinika SZU, F.D.Roosevelt Hospital; 🇸🇰 Banska Bystrica, Slovakia