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NCT04450329

A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Completed Phase 3 Results posted Last updated 5 February 2024
What this trial tests

Phase 3 trial testing SB15 (Proposed aflibercept biosimilar) in Neovascular Age-related Macular Degeneration in 449 participants. Completed in 16 March 2022.

Timeline
23 June 2020
Primary endpoint
15 April 2021
16 March 2022

Quick facts

Lead sponsorSamsung Bioepis Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment449
Start date23 June 2020
Primary completion15 April 2021
Estimated completion16 March 2022
Sites38 locations across Japan, Russia, Estonia, Hungary, Poland, South Korea, Latvia, Croatia

Drugs / interventions tested

Conditions studied

Sponsor

Samsung Bioepis Co., Ltd. — full company profile →

Who can join

50 and older, any sex, with Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Best Corrected Visual Acuity (BCVA) Primary · Baseline and Week 8

The VA was assessed using original series ETDRS charts or 2702 series number charts.

GroupValue95% CI
SB15 (Proposed Aflibercept Biosimilar)6.7± 0.56
Eylea (Aflibercept)6.6± 0.57

Adverse events — posted to ClinicalTrials.gov

Time frame: Overall Period (56 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SB15 (Proposed Aflibercept Biosimilar)
Serious: 22/224 (10%)
Deaths: 1/224
Eylea (Aflibercept)
Serious: 27/224 (12%)
Deaths: 2/224
Eylea (Aflibercept) to SB15
Serious: 9/111 (8%)
Deaths: 0/111
Eylea (Aflibercept) to Eylea
Serious: 13/104 (13%)
Deaths: 1/104

Serious adverse events (54 terms)

ReactionSystemSB15 (Proposed Aflibercept…Eylea (Aflibercept)Eylea (Aflibercept) to SB15Eylea (Aflibercept) to Eylea
Disease progressionGeneral disorders
PneumoniaInfections and infestations
OsteoarthritisMusculoskeletal and connective tissue disorders
Ischaemic strokeNervous system disorders
AnaemiaBlood and lymphatic system disorders
Acute myocardial infarctionCardiac disorders
Angina unstableCardiac disorders
Cardiac failureCardiac disorders
Cardiac failure acuteCardiac disorders
Vertigo positionalEar and labyrinth disorders
Retinal haemorrhageEye disorders
Neovascular age-related macular degenerationEye disorders
Retinal vascular disorderEye disorders
Visual acuity reducedEye disorders
Vitreous haemorrhageEye disorders
Duodenal ulcer haemorrhageGastrointestinal disorders
IleusGastrointestinal disorders
Mechanical ileusGastrointestinal disorders
Pancreatitis acuteGastrointestinal disorders
SubileusGastrointestinal disorders
DeathGeneral disorders
Bile duct stoneHepatobiliary disorders
Cholecystitis acuteHepatobiliary disorders
COVID-19 pneumoniaInfections and infestations
CellulitisInfections and infestations
Other adverse events (2 terms — click to expand)

ReactionSystemSB15 (Proposed Aflibercept…Eylea (Aflibercept)Eylea (Aflibercept) to SB15Eylea (Aflibercept) to Eylea
Neovascular age-related macular degenerationEye disorders
Visual acuity reducedEye disorders

Most-reported serious reactions: Disease progression, Pneumonia, Osteoarthritis, Ischaemic stroke, Anaemia, Acute myocardial infarction, Angina unstable, Cardiac failure.

Data from ClinicalTrials.gov NCT04450329 adverse events section.

Sponsor's own description

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR BIOSIMILARS IN OPHTHALMOLOGY.
    Kaiser PK, Schmitz-Valckenberg MS, Holz FG. · · 2022 · cited 36× · PMID 36394884 · DOI 10.1097/iae.0000000000003626
  2. An update on long-acting therapies in chronic sight-threatening eye diseases of the posterior segment: AMD, DMO, RVO, uveitis and glaucoma.
    Ghanchi F, Bourne R, Downes SM, Gale R, et al · · 2022 · cited 35× · PMID 34974541 · DOI 10.1038/s41433-021-01766-w
  3. Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial.
    Woo SJ, Bradvica M, Vajas A, Sagong M, et al · · 2023 · cited 27× · PMID 37289448 · DOI 10.1001/jamaophthalmol.2023.2260
  4. New frontiers of retinal therapeutic intervention: a critical analysis of novel approaches.
    Nanegrungsunk O, Au A, Sarraf D, Sadda SR. · · 2022 · cited 14× · PMID 35467460 · DOI 10.1080/07853890.2022.2066169
  5. Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial.
    Sadda SR, Bradvica M, Vajas A, Sagong M, et al · · 2023 · cited 10× · PMID 38114333 · DOI 10.1136/bmjophth-2023-001561
  6. Initial Experience With Biosimilar Bevacizumab-bvzr For Intravitreal Use in Children: A Case Series and Literature Review.
    Jung EE, Lee TC, Nagiel A. · · 2023 · cited 4× · PMID 36780635 · DOI 10.3928/23258160-20230130-01
  7. Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases.
    Van de Wiele VL, Hammer M, Parikh R, Feldman WB, et al · · 2022 · cited 3× · PMID 35211322 · DOI 10.1093/jlb/lsac001
  8. Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea<sup>®</sup>).
    Lee H, Huh J, Kim D, Lee S, et al · · 2024 · cited 2× · PMID 38878130 · DOI 10.1007/s40123-024-00977-0

Verify or expand the search:

Other recruiting trials for Neovascular Age-related Macular Degeneration

Currently open trials in the same condition.

Other Samsung Bioepis Co., Ltd. trials

Trials by the same sponsor.

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