A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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
1 other identifier
interventional
705
9 countries
75
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
March 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2019
CompletedResults Posted
Study results publicly available
May 21, 2021
CompletedMay 21, 2021
April 1, 2021
1.2 years
May 10, 2017
April 29, 2021
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Best Corrected Visual Acuity (BCVA)
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Baseline and Week 8
Change From Baseline in Central Subfield Thickness (CST)
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT
Baseline and Week 4
Study Arms (2)
SB11 (Proposed ranibizumab biosimilar)
EXPERIMENTALLucentis (ranibizumab)
ACTIVE COMPARATORInterventions
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
Retina consultants San Diego
Poway, California, 92064, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909, United States
Retina Consultants
Fort Myers, Florida, 33912, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Raj K. Maturi, MD, PC
Indianapolis, Indiana, 46280, United States
Retina Center of New Jersey, LLC
Bloomfield, New Jersey, 07003, United States
NJ Retina
Toms River, New Jersey, 08755-8063, United States
LIVR
Great Neck, New York, 11021, United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11788, United States
Retina Associates of Western NY
Rochester, New York, 14620, United States
Retina Vitreous Surgeons fo Central NY, PC
Syracuse, New York, 13224, United States
Retina Associates of Cleveland
Middleburg Heights, Ohio, 44130, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29414, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Austin Restina Associates
Austin, Texas, 78705, United States
Retina consultants of Houston
Conroe, Texas, 77030, United States
Retina Consultants of Houston
Houston, Texas, 77030, 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
Related Publications (2)
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.
PMID: 36520462DERIVEDWoo 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.
PMID: 33211076DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Investigator agree to submit any proposed publication/presentation to Sponsor for review at least sixty days prior to submitting any such proposed publication to a publisher or proceeding with such proposed presentation.
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Samsung Bioepis Co., Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Se Joon Woo
Seoul National University Bundang Hospital, South Korea
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 12, 2017
Study Start
March 14, 2018
Primary Completion
May 24, 2019
Study Completion
December 9, 2019
Last Updated
May 21, 2021
Results First Posted
May 21, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share