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A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

NCT03150589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2021-05-21

Study results available
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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.

Conditions

  • Age-Related Macular Degeneration

Interventions

DRUG

SB11 (Proposed ranibizumab biosimilar)

SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks

DRUG

Lucentis (ranibizumab)

Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

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
2018-03-14
Primary Completion
2019-05-24
Completion
2019-12-09
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Hungary
  • India
  • Poland
  • Russia
  • South Korea
  • United Kingdom

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 NCT03150589 on ClinicalTrials.gov