A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 2/1/2019 |
Start Date: | March 14, 2018 |
End Date: | November 28, 2019 |
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
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.
efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in
subjects with neovascular 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.
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.
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
We found this trial at
20
sites
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