Ireland
--:--IST
Active, not recruiting Phase 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

NCT07844343 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2026-09-07
Last updated
2026-09-28

Condition(s) studied

Neovascular Age-related Macular DegenerationMacular Oedema Secondary to RVODiabetic Macular Oedema

Investigational drug(s) / intervention(s)

SB15 PFS

SB15 PFS: SB15 provided in a pre-filled syringe (PFS) containing 2 mg aflibercept in 0.05 mL for intravitreal injection

Study 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 nAMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema (DME).

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: (Key) * 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 Exclusion Criteria: (Key) * 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

Primary outcome measure(s)

  • Percentage of Successful Task Completions on All of the 12 tasks — Day 1
    A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured.
  • Incidence of ocular adverse events (AEs) — Day 1 to Day 7

Trial sites (3)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Kim's Eye Hospital Seoul South Korea
Nune Eye Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07844343 on ClinicalTrials.gov ↗ ← All trials in South Korea