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

Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52.

• SB11 (Proposed ranibizumab biosimilar) (Drug): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
• Lucentis (ranibizumab) (Drug): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

Primary outcomes

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Baseline and Week 8]: The VA was assessed using original series ETDRS charts or 2702 series number charts.
• Change From Baseline in Central Subfield Thickness (CST) [Baseline and Week 4]: The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT

Sex: All, ages: 50 Years to any

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

Participant flow

Outcome results

• Change From Baseline in Best Corrected Visual Acuity (BCVA) (Primary), Least squares mean, letters: SB11 (Proposed Ranibizumab Biosimilar) 6.26 +/- 0.51; Lucentis (Ranibizumab) 7.08 +/- 0.51
• Change From Baseline in Central Subfield Thickness (CST) (Primary), Least squares mean, μm: SB11 (Proposed Ranibizumab Biosimilar) -108.40 +/- 4.65; Lucentis (Ranibizumab) -100.05 +/- 4.64

Adverse events

Time frame: From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit

Serious adverse events by term

36 more terms not shown.

Other adverse events by term

Limitations and caveats: Investigator agree to submit any proposed publication/presentation to Sponsor for review at least sixty days prior to submitting any such proposed publication to a publisher or proceeding with such proposed presentation.

• Results publication: Bressler NM, Kim T, Oh I, Russo P, Kim MY, Woo SJ. Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Feb 1;141(2):117-127. doi: 10.1001/jamaophthalmol.2022.5403. PMID 36520462
• Results publication: Woo SJ, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, Vajas A, Papp A, Gabor V, Luu J, Matuskova V, Yoon YH, Pregun T, Kim T, Shin D, Bressler NM. Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jan 1;139(1):68-76. doi: 10.1001/jamaophthalmol.2020.5053. PMID 33211076

• Study Protocol and Statistical Analysis Plan (PDF, 2017-09-01)

• Se Joon Woo, Principal investigator, Seoul National University Bundang Hospital, South Korea