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CompletedNCT07550504Updated Apr 24, 2026

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

A Phase 2 interventional study of SB11 PFS in Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema and Central Retinal Vein Occlusion With Macular Edema, sponsored by Samsung Bioepis Co., Ltd.. Completed at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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

Read the detailed description

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.

02

Conditions studied

  • Age-Related Macular Degeneration
  • Branch Retinal Vein Occlusion With Macular Edema
  • Central Retinal Vein Occlusion With Macular Edema
  • Myopic Choroidal Neovascularization
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    SB11 PFS

    Trial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.

    Combination Product: SB11 PFS

Interventions

  • Combination productSB11 PFS

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

    Also known as: ranibizumab

05

What researchers measure

Primary outcomes

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

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

    Time frame: Day 1

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

06

Study locations

2 sites
  • Research site
    Krakow, Poland
  • Research site
    Olsztyn, Poland
07

Registry details

Key details

Study ID
NCT07550504
Lead sponsor
Samsung Bioepis Co., Ltd.
Responsible party
Sponsor
First posted
Apr 24, 2026
Start date
Mar 30, 2026
Primary completion
Mar 31, 2026
Completion
Apr 9, 2026
Last update
Apr 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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