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
Condition(s) studied
Investigational drug(s) / intervention(s)
SB15 PFS: SB15 provided in a pre-filled syringe (PFS) containing 2 mg aflibercept in 0.05 mL for intravitreal injection
Study 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).
Eligibility
Primary outcome measure(s)
- Percentage of Successful Task Completions on All of the 12 tasks — Day 1
A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured. - Incidence of ocular adverse events (AEs) — Day 1 to Day 7
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | |
| Kim's Eye Hospital | Seoul | South Korea | |
| Nune Eye Hospital | Seoul | South Korea |
More Samsung Bioepis Co., Ltd. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07844343 on ClinicalTrials.gov ↗ ← All trials in South Korea