Phase 2CompletedAge-related condition
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
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)
- Sponsor
- Samsung Bioepis Co., Ltd. (Industry)
- Enrolment
- 33 enrolled
- Conditions
- Neovascular Age-related Macular Degeneration; Macular Oedema Secondary to RVO; Diabetic Macular Oedema
- Interventions
- SB15 PFS
- Ages
- adults, older adults
- Registry
- NCT07844343
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Percentage of Successful Task Completions on All of the 12 tasks
- Incidence of ocular adverse events (AEs)
History
Last registry update
Registered
Primary completion
Started