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Completed

NCT Number: NCT07550504

A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV

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 trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).

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Key information

Conditions

Age-Related Macular Degeneration Branch Retinal Vein Occlusion With Macular Edema Central Retinal Vein Occlusion With Macular Edema Eye Diseases Macular Degeneration Myopic Choroidal Neovascularization Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research site, Krakow, Poland

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About this study

HCPs will prepare and administer intravitreal injections of SB11 0.5 mg delivered via PFS to trial participants on Day 1 and safety follow-up will be assessed until Day 7.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Only one eye will be selected as the study eye.

Key Inclusion Criteria:

  • Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye
  • Study eye deemed to be indicated for ranibizumab IVT therapy at the discretion of the ophthalmologist (e.g., retina specialist)

Key Exclusion Criteria:

  • BCVA of the level of Finger Count or worse [e.g., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
  • Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye
  • Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
  • Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
  • Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1

Treatment and study plan

SB11 PFS

Combination Product

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

Other names: ranibizumab

Primary outcomes

  1. Percentage of Successful Task Completions on All of the 12 tasks

    Time frame: Day 1

    A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured.

Secondary outcomes

  1. Percentage of Successful Completion on Each of 12 tasks

    Time frame: Day 1

  2. Incidence of AEs and serious adverse events (SAEs)

    Time frame: From Day 1 to Day 7

  3. Change from baseline in Best Corrected Visual Acuity (BCVA)

    Time frame: From Day 1 to Day 7

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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