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COMPLETED
NCT07844343
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

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