CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
SB11 PFScombination
Likely dose
SB11 PFS 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06176963
NCT06176963Phase 2Completed
CompareCT.gov

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

Samsung Bioepis Co., Ltd.·interventional·Posted Dec 20, 2023·Updated Dec 30, 2024

In Brief

A Phase 2 clinical trial evaluating SB11 PFS for Neovascular Age-related Macular Degeneration and 2 related conditions. Completed, enrolled 34 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Age-related Macular Degeneration, Macular Edema, Retinal Vein Occlusion
CountriesPoland
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedDec 20, 2023
Enrollment StartNov 21, 2023
Primary CompletionNov 30, 2023
Study CompletionDec 12, 2023
TodayJul 2, 2026
Enrollment to primary: 9 daysPosted 2.5 years ago

Interventions

SB11 PFScombination

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