NCT07844343CompletedPhase 2
A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema
An Open-label, Single-arm, Single-dose Clinical Trial to Evaluate the Safety and Usability of SB15 Pre-filled Syringe (PFS) in Trial Participants With Neovascular Age-related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Diabetic Macular Oedema (DME)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
This is an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB15 PFS with intravitreal injection to trial participants with nAMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema (DME).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 21 Sept 2026
- Start date
- 7 Sept 2026
- Primary completion date
- 22 Sept 2026
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT07844343
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 33
- From 7 Sept 2026 to the primary completion date, 22 Sept 2026
- 3 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
- History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after IVT injection or intraocular procedures in either eye
Other illness
- History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past IVT injections with any agent in either eye
- Active or suspected infectious disease (ocular or periocular) in either eye at Screening or at Day 1
- History of massive subconjunctival haemorrhages of concern reported by the trial participant after an IVT injection in either eye
- Current vitreous haemorrhage in the study eye
Who the study is looking for
- Neovascular AMD, macular oedema secondary to RVO (branch RVO or central RVO), or DME in the study eye
- Best Corrected Visual Acuity (BCVA) of ≥20/400 (letter score of ≥19) in the study eye and ≥20/800 (letter score of ≥4) in the fellow eye using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series Number charts at Screening and at Day 1
- Study eye deemed to be indicated for continued aflibercept IVT therapy at the discretion of the retina specialist, and IP administration to be performed at the retina specialist's judgment
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Nune Eye Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kim's Eye Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.