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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: SB11 (Proposed ranibizumab biosimilar)
* Drug: Lucentis (ranibizumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye BCVA of 20/40 to 20/200 in the study eye Written informed consent form Exclusion Criteria: Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye 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 Any concurrent macular abnormality other than AMD in the study eye

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB11 (Proposed ranibizumab biosimilar)<br> | Drug: SB11 (Proposed ranibizumab biosimilar)<br>* SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks<br>|
| Active Comparator: Lucentis (ranibizumab)<br> | Drug: Lucentis (ranibizumab)<br>* Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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