Neovascular Age-related Macular DegenerationPhase 2NCT07844343
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
A Phase 2 study testing SB15 PFS in people with Neovascular Age-related Macular Degeneration and Macular Oedema Secondary to RVO, run by Samsung Bioepis Co., Ltd. at 3 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO, Diabetic Macular Oedema
- What is being tested?
- SB15 PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 7 Sep 2026to 22 Sep 2026
- Phase
- Phase 2
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after IVT injection or intraocular procedures in either eye
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Kim's Eye Hospital
Seoul
Nune Eye Hospital
Seoul
About this study
Official title: 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)
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).
Read the detailed description
HCPs will prepare and administer intravitreal injections of SB15 2 mg delivered via PFS to trial participants on Day 1 and safety follow-up will be assessed until Day 7.
- Conditions
- Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO, Diabetic Macular Oedema
- Being tested
- SB15 PFS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB15 PFSCombination product
Also called aflibercept
SB15 provided in a pre-filled syringe (PFS) containing 2 mg aflibercept in 0.05 mL for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| SB15 PFS | Experimental | Trial participants received a single dose of SB15 PFS containing 2 mg aflibercept in 0.05 mL solution. Receives: Combination Product: SB15 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
Incidence of ocular adverse events (AEs)
Measured: Day 1 to Day 7
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start7 Sep 2026
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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
- 33 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
- NCT07844343
- Sponsor's protocol ID
- SB15-2001
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No