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

Samsung

Status and phase: Completed; Phase 3

Conditions: Age-Related Macular Degeneration

Treatments: Drug: SB11 (Proposed ranibizumab biosimilar); Drug: Lucentis (ranibizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03150589

SB11-G31-AMD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 705 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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705 participants in 2 patient groups

SB11 (Proposed ranibizumab biosimilar)

Experimental group

Treatment:

Drug: SB11 (Proposed ranibizumab biosimilar)

Lucentis (ranibizumab)

Active Comparator group

Treatment:

Drug: Lucentis (ranibizumab)