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

Phase 3

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: SB11 (Proposed ranibizumab biosimilar); Drug: Lucentis (ranibizumab)

• Registration Number: NCT03150589
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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 Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Study Start: 2018-03-14
• Disposition First Submitted: 2019-01-28
• Disposition First Submitted QC: 2019-01-28
• Disposition First Posted: 2019-01-30
• Primary Completion: 2019-05-24
• Study Completion: 2019-12-09
• Status Verified: 2021-04
• Results First Submitted: 2021-04-29
• Results First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Results First Posted: 2021-05-21
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB11 (Proposed ranibizumab biosimilar)	SB11 (Proposed ranibizumab biosimilar)	-
Lucentis (ranibizumab)	Lucentis (ranibizumab)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA)	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)	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

Trial Locations

Locations (74)

Retina consultants San Diego; 🇺🇸 Poway, California, United States

Retina Consultants of Southern Colorado; 🇺🇸 Colorado Springs, Colorado, United States

Retina Consultants; 🇺🇸 Fort Myers, Florida, United States

Southeast Retina Center; 🇺🇸 Augusta, Georgia, United States

Retina Consultants of Hawaii; 🇺🇸 'Aiea, Hawaii, United States

Raj K. Maturi, MD, PC; 🇺🇸 Indianapolis, Indiana, United States

Retina Center of New Jersey, LLC; 🇺🇸 Bloomfield, New Jersey, United States

NJ Retina; 🇺🇸 Toms River, New Jersey, United States

LIVR; 🇺🇸 Great Neck, New York, United States

Long Island Vitreoretinal Consultants; 🇺🇸 Hauppauge, New York, United States

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