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

NCT04450329 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2024-02-05

Study results available
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Summary

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.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

SB15 (Proposed aflibercept biosimilar)

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. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.

DRUG

Eylea (Aflibercept)

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.

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Se Joon Woo · Seoul National University Bundang Hospital, South Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2021-04-15
Completion
2022-03-16
FDA Drug
Yes

Countries

  • United States
  • Croatia
  • Czechia
  • Estonia
  • Hungary
  • Japan
  • Latvia
  • Poland
  • Russia
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450329 on ClinicalTrials.gov