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

Overview

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.

Full Title of Study: “A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 24, 2019

Detailed Description

Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52.

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

Arms, Groups and Cohorts

  • Experimental: SB11 (Proposed ranibizumab biosimilar)
  • Active Comparator: Lucentis (ranibizumab)

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Best Corrected Visual Acuity (BCVA)
    • Time Frame: Baseline and Week 8
    • The VA was assessed using original series ETDRS charts or 2702 series number charts.
  • Change From Baseline in Central Subfield Thickness (CST)
    • Time Frame: Baseline and Week 4
    • The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥ 50 years 2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye 3. BCVA of 20/40 to 20/200 in the study eye 4. Written informed consent form Exclusion Criteria:

1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye 2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia 3. Any concurrent macular abnormality other than AMD in the study eye

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Bioepis Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Se Joon Woo, Principal Investigator, Seoul National University Bundang Hospital, South Korea

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