drugset / Trial / NCT07844343

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

NCT07844343 ↗

Phase 2 Active not recruiting 33 enrolled Samsung Bioepis Co., Ltd.
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2026-09-07
Primary completion
2026-09-22
Completion
2026-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject SB15 Unknown 2 mg Intravitreal