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

Completed · Phase 3

Conditions studied: Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03150589

Run by

Samsung Bioepis Co., Ltd.

People needed

705

Starts

2018-03-14

Expected to finish

2019-12-09

Last updated by the study team

2021-05-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 50 years
• Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye
• BCVA of 20/40 to 20/200 in the study eye
• Written informed consent form

You may not qualify if…

• Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye
• 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
• Any concurrent macular abnormality other than AMD in the study eye

Where it is running

• 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
• Retina Associates of Western NY — Rochester, New York, United States
• Retina Vitreous Surgeons fo Central NY, PC — Syracuse, New York, United States
• Retina Associates of Cleveland — Middleburg Heights, Ohio, United States
• Charleston Neuroscience Institute — Ladson, South Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Austin Restina Associates — Austin, Texas, United States
• Retina consultants of Houston — Conroe, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States
• University Hospital Brno — Brno, Czechia
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• University Hospital Olomouc — Olomouc, Czechia
• University Hopsital Ostrava — Ostrava, Czechia
• Axon Clinical s.r.o. — Prague, Czechia
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
• Retina consultants San Diego — Poway, California, United States

Full record on ClinicalTrials.gov

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