NCT07550504CompletedPhase 2
A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 19 Apr 2026
- Start date
- 30 Mar 2026
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Diseases
- Macular degeneration
- NCT number
- NCT07550504
- EU CT number
- 2025-520599-24-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 30 Mar 2026 to the primary completion date, 31 Mar 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye
- 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
Lab values
- 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
Other
- Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
Who the study is looking for
- 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)
Criteria the registry did not label
- Only one eye will be selected as the study eye.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Como Centrum Okulistyki Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Medyczne Dietla 19 Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Gabinet Okulistyczny Prof Edward Wylegala Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.