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Monoclonal Antibodies
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Phase 3
Waitlist Available
Led By Se Joon Woo
Research Sponsored by Samsung Bioepis Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 8
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
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.
Eligible Conditions
- Age-Related Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Change From Baseline in Central Subfield Thickness (CST)
Side effects data
From 2019 Phase 3 trial • 705 Patients • NCT0315058911%
Nasopharyngitis
7%
Intraocular pressure increased
7%
Neovascular age-related macular degeneration
6%
Visual acuity reduced
5%
Conjunctival haemorrhage
5%
Hypertension
1%
Cataract
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Endophthalmitis
1%
Retinal haemorrhage
1%
Cardiac failure congestive
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
SB11 (Proposed Ranibizumab Biosimilar)
Lucentis (Ranibizumab)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SB11 (Proposed ranibizumab biosimilar)Experimental Treatment1 Intervention
Group II: Lucentis (ranibizumab)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranibizumab
FDA approved
Find a Location
Who is running the clinical trial?
Samsung Bioepis Co., Ltd.Lead Sponsor
31 Previous Clinical Trials
9,222 Total Patients Enrolled
Se Joon WooPrincipal InvestigatorSeoul National University Bundang Hospital, South Korea
1 Previous Clinical Trials
449 Total Patients Enrolled