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Completed NCT07844343

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

Conditions: Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO, Diabetic Macular Oedema

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 33
Sponsor: Samsung Bioepis Co., Ltd.

Location: Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07844343). StuddyBuddy aggregates publicly available trial information.