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

NCT04739306 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CT-P42 3.1
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean Change From Baseline in BCVA at Week 52

  Baseline and Week 52

• 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 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

• Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)

  Baseline and Week 52

Study Arms (2)

CT-P42

EXPERIMENTAL

Biological: CT-P42

Eylea

ACTIVE COMPARATOR

Biological: Eylea

Interventions

CT-P42 BIOLOGICAL

2mg/0.05 mL by Intravitreal injection

CT-P42

Eylea BIOLOGICAL

2mg/0.05 mL by Intravitreal injection

Eylea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient who has only one functional eye.
• Patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

II. Ocna klinika SZU, F.D.Roosevelt Hospital

Banská Bystrica, Slovakia

Location

Related Publications (1)

• Brown DM, Wolf S, Veselovsky M, Veith M, Papp A, Mange S, Mondal LK, Romanczak D, Janco L, Chauhan R, Romanowska-Dixon B, Eremina A, Dusova J, Sagong M, Kim S, Bae Y, Kim S, Bae Y, Son D, Kang H, Choi S, Stanga PE. Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. Ophthalmol Ther. 2025 Nov;14(11):2769-2783. doi: 10.1007/s40123-025-01197-w. Epub 2025 Aug 29.

  PMID: 40879891 DERIVED

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Head of Clinical Planning
• Organization: CELLTRION, Inc.

keumyoung.ahn@celltrion.com

+82-32-850-4190

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: July 22, 2021
• Primary Completion: October 14, 2022
• Study Completion: April 24, 2023
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-09

Locations

SL (1)