A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oed… (NCT07550504) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV
Poland30 participantsStarted 2026-03-30
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a pre-filled syringe device called the SB11 PFS for conditions like wet AMD and macular oedema from retinal vein occlusion — since it's already completed, has the usability data been published, and could that device or the drug it delivers be relevant to my treatment?
2The trial measured whether participants could successfully complete 12 specific tasks with this pre-filled syringe — does that mean the focus was on how easy the injection process is to perform, and does that have any bearing on how my injections would be given in practice?
3Since this was a Phase 2 study that is now completed, what would the next steps typically be for a device like this, and is there a later-phase trial or approved version of SB11 that might be more directly relevant to my care?
4My condition was one of the ones studied here — wet AMD, macular oedema from vein occlusion, or myopic choroidal neovascularization — so would you consider the drug delivered by this device (SB11) a potential option for me, and how does it compare to what I might receive through standard treatment?
5Because this trial is completed and I can't enrol, are there any currently open trials studying similar treatments for my specific diagnosis that you think would be worth looking into alongside standard care options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Successful Task Completions on All of the 12 tasks