SB11-G31-AMD-Comparison of efficacy&safety of SB11 and Lucentis in AMD
Research type
Research Study
Full title
A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB11 (proposed ranibizumab biosimilar) and Lucentis® in Subjects with Neovascular Age-related Macular Degeneration
IRAS ID
235783
Contact name
Adam Ross
Contact email
Sponsor organisation
Samsung Bioepis Co., Ltd
Eudract number
2017-000422-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Age-related macular degeneration (AMD) is a common eye condition and a cause of vision loss among people aged 50 and older. It is characterised by damage to the macula - part of the eye needed for sharp, central vision. In neovascular (wet) AMD, blood vessels grow, these can leak fluid and blood causing central vision to be blurred, decreased or even lost. AMD, left untreated, is a leading cause of adult blindness. \n\nIn this study we will evaluate if a new treatment, SB11, is as effective and safe as ranibizumab (Lucentis®) at treating neovascular AMD. Lucentis® is already approved to treat neovascular AMD. SB11 is a biological medicine that is similar to Lucentis®. Lucentis® and SB11 contain an antibody that sticks to VEGF-A, this prevents VEGF-A interacting with receptors on the surface of endothelial cells (cells that line blood vessels). This stops VEGF-A causing an increase in cell numbers, new blood vessels forming and leakage from blood vessels all of which contribute to neovascular AMD worsening. \n\nPatients recruited into the study will be aged 50 or over with newly diagnosed, active subfoveal Choroidal Neovascularisation lesion (growth of new blood vessels that originate from the choroid underneath the retina) secondary to AMD. This is a double-masked study, neither the patient nor the doctor will know if the patient is receiving SB11 or Lucentis®. Patients will be randomised (assigned by chance similar to flipping a coin) and have an equal chance of receiving SB11 or Lucentis®. \n\nIf eligible for the study patients will enter the treatment period; patients will be administered SB11 or Lucentis® via an injection into the eye every 4 weeks up to a total of 13 administrations. After the treatment period patients will attend an End of Study visit. In total there are 16 visits at the study centre.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0273
Date of REC Opinion
3 Jan 2018
REC opinion
Further Information Favourable Opinion