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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 : Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Description
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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
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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
Estimated Primary Completion Date : January 24, 2019
Estimated Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change from baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline and Week 8 ]
  2. Change from baseline in Central Subfield Thickness (CST) [ Time Frame: Baseline and Week 4 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
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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


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Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
Principal Investigator: Se Joon Woo Seoul National University Bundang Hospital, South Korea
More Information
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03150589     History of Changes
Other Study ID Numbers: SB11-G31-AMD
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
 Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents