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 | Active Not Recruiting Phase 2

• 1 other identifier: SB15-2001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Neovascular Age-related Macular Degeneration; Macular Oedema Secondary to RVO; Diabetic Macular Oedema

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• Incidence of ocular adverse events (AEs)

  Day 1 to Day 7

Secondary Outcomes (2)

• Percentage of Successful Completion on Each of 12 tasks

  Day 1

• Incidence of AEs and serious adverse events (SAEs)

  From Day 1 to Day 7

Study Arms (1)

SB15 PFS

EXPERIMENTAL

Trial participants received a single dose of SB15 PFS containing 2 mg aflibercept in 0.05 mL solution.

Combination Product: SB15 PFS

Interventions

SB15 PFS COMBINATION_PRODUCT

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

Also known as: aflibercept

SB15 PFS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Kim's Eye Hospital

Seoul, South Korea

Location

Nune Eye Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: September 7, 2026
• Primary Completion: September 22, 2026
• Study Completion: September 22, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)