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

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ClinicalTrials.gov Identifier: NCT03150589
Recruitment Status : Completed
First Posted : May 12, 2017
Results First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 10, 2017
First Posted Date  ICMJE May 12, 2017
Results First Submitted Date  ICMJE April 29, 2021
Results First Posted Date  ICMJE May 21, 2021
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE March 14, 2018
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2021)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Week 8 ]
  • Change From Baseline in Central Subfield Thickness (CST) [ Time Frame: Week 4 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: SB11 (Proposed ranibizumab biosimilar)
    Intervention: Drug: SB11 (Proposed ranibizumab biosimilar)
  • Active Comparator: Lucentis (ranibizumab)
    Intervention: Drug: Lucentis (ranibizumab)
Publications * Woo SJ, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, Vajas A, Papp A, Gabor V, Luu J, Matuskova V, Yoon YH, Pregun T, Kim T, Shin D, Bressler NM. Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jan 1;139(1):68-76. doi: 10.1001/jamaophthalmol.2020.5053.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2019)
705
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2017)
704
Actual Study Completion Date  ICMJE December 9, 2019
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Hungary,   India,   Korea, Republic of,   Poland,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03150589
Other Study ID Numbers  ICMJE SB11-G31-AMD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Se Joon Woo Seoul National University Bundang Hospital, South Korea
PRS Account Samsung Bioepis Co., Ltd.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP