NCT06176963

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.

Detailed description

This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO. Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2).

Conditions

• Neovascular Age-related Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SB11 PFS	SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection

Timeline

• Start date: 2023-11-21
• Primary completion: 2023-11-30
• Completion: 2023-12-12
• First posted: 2023-12-20
• Last updated: 2024-12-30
• Results posted: 2024-12-30

Locations

3 sites across 1 country: Poland

Regulatory

• FDA-regulated drug study