A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT ID: NCT03150589
Last Updated: 2021-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
705 participants
INTERVENTIONAL
2018-03-14
2019-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SB11 (Proposed ranibizumab biosimilar)
SB11 (Proposed ranibizumab biosimilar)
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab)
Lucentis (ranibizumab)
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Interventions
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SB11 (Proposed ranibizumab biosimilar)
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab)
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
ALL
No
Sponsors
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Samsung Bioepis Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Se Joon Woo
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital, South Korea
Locations
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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
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
Augenärzte am St. Franziskus-Hospital Münster
Münster, Munster, Germany
Charite
Berlin, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Uni Düsseldorf
Düsseldorf, , Germany
University Medical Center, Freiburg
Freiburg im Breisgau, , Germany
Uni Göttingen
Goettigen, , Germany
TU Munich
München, , Germany
MVZ ADTC Siegburg GmbH
Siegburg, , Germany
University of Tuebingen STZ eyetrial at the Department of Ophthalmology
Tübingen, , Germany
Ganglion Orvosi Kozpont
Pécs, Pecs, Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, , Hungary
Budapest Retina Associates Ltd.
Budapest, , Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
Budapest, , Hungary
Semmelweis Egyetem Szemeszeti Klinika
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Szemklinika
Debrecen, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
Medilink Hospital
Ahmedabad, , India
PGIMER
Chandigarh, , India
Shankara Netralaya
Chennai, , India
Aravind Eye Hospital
Coimbatore, , India
Shroff eye Hospital
Mumbai, , India
Regional Institute of Opthalmology
Trivandrum, , India
Centrum Medyczne UNO-MED.
Tarnów, Tarnow, Poland
Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
Wałbrzych, Walbrzych, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
Wroclaw, Wroclaw, Poland
Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz
Bydgoszcz, , Poland
Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała
Katowice, , Poland
Centrum Medyczne UNO-MED.
Krakow, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, , Poland
"State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan"
Kazan', , Russia
Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex
Moscow, , Russia
Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases"
Moscow, , Russia
Federal State Autonomous Institution "Intersectoral research and technical complex "Eye Microsurgery" named after acad. S.N. Fyodorov" of Ministry of Health of Russian Federation
Novosibirsk, , Russia
Federal State Educational Institution of High Professional Education "1st Saint-Petersburg State Medical University n.a. academic I.P. Pavlov" of Ministry of Healthcare of Russian Federation
Saint Petersburg, , Russia
SBEI HPE "Samara State Medical University" of the MoH of the RF
Samara, , Russia
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Queens University Belfast
Belfast, , United Kingdom
Bristol Eye Hospital
Bristol, , United Kingdom
Frimley Park Hospital
Frimley, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Countries
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References
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Bressler NM, Kim T, Oh I, Russo P, Kim MY, Woo SJ. Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Feb 1;141(2):117-127. doi: 10.1001/jamaophthalmol.2022.5403.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SB11-G31-AMD
Identifier Type: -
Identifier Source: org_study_id
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