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A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema
Sponsor: Samsung Bioepis Co., Ltd.
Summary
This is an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB15 PFS with intravitreal injection to trial participants with nAMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema (DME).
Official title: An Open-label, Single-arm, Single-dose Clinical Trial to Evaluate the Safety and Usability of SB15 Pre-filled Syringe (PFS) in Trial Participants With Neovascular Age-related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Diabetic Macular Oedema (DME)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2026-09-07
Completion Date
2026-09-22
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
SB15 PFS
SB15 provided in a pre-filled syringe (PFS) containing 2 mg aflibercept in 0.05 mL for intravitreal injection
Locations (3)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kim's Eye Hospital
Seoul, South Korea
Nune Eye Hospital
Seoul, South Korea