Age-Related Macular DegenerationPhase 2NCT07550504
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 study testing SB11 PFS in people with Age-Related Macular Degeneration and Branch Retinal Vein Occlusion With Macular Edema, run by Samsung Bioepis Co., Ltd. at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema, Central Retinal Vein Occlusion With Macular Edema
- What is being tested?
- SB11 PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPoland
- Study dates
- 30 Mar 2026to 9 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official 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
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.
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema, Central Retinal Vein Occlusion With Macular Edema, Myopic Choroidal Neovascularization
- Being tested
- SB11 PFS
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB11 PFSCombination product
Also called ranibizumab
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| SB11 PFS | Experimental | Trial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution. Receives: Combination Product: SB11 PFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
Percentage of Successful Completion on Each of 12 tasks
Measured: Day 1
Incidence of AEs and serious adverse events (SAEs)
Measured: From Day 1 to Day 7
Change from baseline in Best Corrected Visual Acuity (BCVA)
Measured: From Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start30 Mar 2026
- Primary completion31 Mar 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550504
- Sponsor's protocol ID
- SB11-2002
- Other IDs
- 2025-520599-24-00, 2025
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07550504
- Acronym / sponsor ID
- SB11-2002
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema, Central Retinal Vein Occlusion With Macular Edema, Myopic Choroidal Neovascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB11 PFS | Experimental | Combination Product: SB11 PFSTrial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB11 PFSAlso: ranibizumabSB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection | Combination product | SB11 PFS |
Primary outcome
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.
3 secondary outcomes
Percentage of Successful Completion on Each of 12 tasks
Time frame: Day 1
Incidence of AEs and serious adverse events (SAEs)
Time frame: From Day 1 to Day 7
Change from baseline in Best Corrected Visual Acuity (BCVA)
Time frame: From Day 1 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB11 PFS in people with Age-Related Macular Degeneration and Branch Retinal Vein Occlusion With Macular Edema, run by Samsung Bioepis Co., Ltd. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Successful Task Completions on All of the 12 tasks (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.