A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV

An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Trial Participants With Neovascular Age-Related Macular Degeneration, Macular Oedema Secondary to Retinal Vein Occlusion, or Myopic Choroidal Neovascularization

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).

HCPs will prepare and administer intravitreal injections of SB11 0.5 mg delivered via PFS to trial participants on Day 1 and safety follow-up will be assessed until Day 7.

Only one eye will be selected as the study eye.

Key Inclusion Criteria:

• Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye
• Study eye deemed to be indicated for ranibizumab IVT therapy at the discretion of the ophthalmologist (e.g., retina specialist)

Key Exclusion Criteria:

• BCVA of the level of Finger Count or worse [e.g., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
• Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye
• Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
• Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
• Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1