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Monoclonal Antibodies
A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea 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
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new medication for people with neovascular AMD (a kind of vision loss). The trial will compare the new medication to a currently available one to see if it is more effective, safe, and has fewer side effects.
Eligible Conditions
- 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)
Side effects data
From 2022 Phase 3 trial • 449 Patients • NCT044503298%
Neovascular age-related macular degeneration
7%
Visual acuity reduced
1%
Disease progression
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
SB15 (Proposed Aflibercept Biosimilar)
Eylea (Aflibercept)
Eylea (Aflibercept) to SB15
Eylea (Aflibercept) to Eylea
Awards & Highlights
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: SB15 (Proposed aflibercept biosimilar)Experimental Treatment1 Intervention
Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
Group II: Eylea (Aflibercept)Active Control2 Interventions
Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SB15 (Proposed aflibercept biosimilar)
2020
Completed Phase 3
~450
Find a Location
Who is running the clinical trial?
Samsung Bioepis Co., Ltd.Lead Sponsor
31 Previous Clinical Trials
9,478 Total Patients Enrolled
2 Trials studying Macular Degeneration
739 Patients Enrolled for Macular Degeneration
Se Joon WooPrincipal InvestigatorSeoul National University Bundang Hospital, South Korea
1 Previous Clinical Trials
705 Total Patients Enrolled
1 Trials studying Macular Degeneration
705 Patients Enrolled for Macular Degeneration