Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
NCT ID: NCT04739306
Last Updated: 2023-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
348 participants
INTERVENTIONAL
2021-07-22
2023-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CT-P42
CT-P42
2mg/0.05 mL by Intravitreal injection
Eylea
Eylea
2mg/0.05 mL by Intravitreal injection
Interventions
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CT-P42
2mg/0.05 mL by Intravitreal injection
Eylea
2mg/0.05 mL by Intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* 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 currently has, or has a history (where indicated) of active proliferative diabetic retinopathy
18 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Locations
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II. Ocna klinika SZU, F.D.Roosevelt Hospital
Banská Bystrica, , Slovakia
Countries
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References
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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 Aug 29. doi: 10.1007/s40123-025-01197-w. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CT-P42 3.1
Identifier Type: -
Identifier Source: org_study_id