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
Verified date | September 2023 |
Source | Celltrion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Slovakia | II. Ocna klinika SZU, F.D.Roosevelt Hospital | Banska Bystrica |
Lead Sponsor | Collaborator |
---|---|
Celltrion |
Slovakia,
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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