A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

• Status: Completed
• Trial end date: 2019-12-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Bioepis Co., Ltd.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Age ≥ 50 years

2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye

3. BCVA of 20/40 to 20/200 in the study eye

4. Written informed consent form

Exclusion Criteria:

1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye

2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia

3. Any concurrent macular abnormality other than AMD in the study eye