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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04739306
Other study ID # CT-P42 3.1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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