We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: SB11 (Proposed ranibizumab biosimilar) Drug: Lucentis (ranibizumab) Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 705 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 14, 2018
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : December 9, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SB11 (Proposed ranibizumab biosimilar) Drug: SB11 (Proposed ranibizumab biosimilar)
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Active Comparator: Lucentis (ranibizumab) Drug: Lucentis (ranibizumab)
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150589


Locations
Show Show 75 study locations
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Se Joon Woo Seoul National University Bundang Hospital, South Korea
  Study Documents (Full-Text)

Documents provided by Samsung Bioepis Co., Ltd.:
Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03150589    
Other Study ID Numbers: SB11-G31-AMD
First Posted: May 12, 2017    Key Record Dates
Results First Posted: May 21, 2021
Last Update Posted: May 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents