Clinical trial NCT03150589: A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age-Related Macular Degeneration
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 705
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline and Week 8
measure: Change From Baseline in Central Subfield Thickness (CST)
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Poway
country: United States
facility: Retina consultants San Diego
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Fort Myers
country: United States
facility: Retina Consultants
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD, PC
state: Indiana
city: Bloomfield
country: United States
facility: Retina Center of New Jersey, LLC
state: New Jersey
city: Toms River
country: United States
facility: NJ Retina
state: New Jersey
city: Great Neck
country: United States
facility: LIVR
state: New York
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY
state: New York
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons fo Central NY, PC
state: New York
city: Middleburg Heights
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Restina Associates
state: Texas
city: Conroe
country: United States
facility: Retina consultants of Houston
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Brno
country: Czechia
facility: University Hospital Brno
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava
country: Czechia
facility: University Hopsital Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 5
country: Czechia
facility: Axon Clinical s.r.o.
city: Münster
country: Germany
facility: Augenärzte am St. Franziskus-Hospital Münster
state: Munster
city: Berlin
country: Germany
facility: Charite
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Duesseldorf
country: Germany
facility: Uni Düsseldorf
city: Freiburg
country: Germany
facility: University Medical Center, Freiburg
city: Goettigen
country: Germany
facility: Uni Göttingen
city: Muenchen
country: Germany
facility: TU Munich
city: Siegburg
country: Germany
facility: MVZ ADTC Siegburg GmbH
city: Tuebingen
country: Germany
facility: University of Tuebingen STZ eyetrial at the Department of Ophthalmology
city: Pécs
country: Hungary
facility: Ganglion Orvosi Kozpont
state: Pecs
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Budapest Retina Associates Ltd.
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Szemeszeti Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Szemklinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Ahmedabad
country: India
facility: Medilink Hospital
city: Chandigarh
country: India
facility: PGIMER
city: Chennai
country: India
facility: Shankara Netralaya
city: Coimbatore
country: India
facility: Aravind Eye Hospital
city: Mumbai
country: India
facility: Shroff eye Hospital
city: Trivandrum
country: India
facility: Regional Institute of Opthalmology
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Tarnów
country: Poland
facility: Centrum Medyczne UNO-MED.
state: Tarnow
city: Wałbrzych
country: Poland
facility: Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
state: Walbrzych
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
state: Wroclaw
city: Bydgoszcz
country: Poland
facility: Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała
city: Kraków
country: Poland
facility: Centrum Medyczne UNO-MED.
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS
city: Kazan
country: Russian Federation
facility: "State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan"
city: Moscow
country: Russian Federation
facility: Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex
city: Moscow
country: Russian Federation
facility: Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases"
city: Novosibirsk
country: Russian Federation
facility: Federal State Autonomous Institution "Intersectoral research and technical complex "Eye Microsurgery" named after acad. S.N. Fyodorov" of Ministry of Health of Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: 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
city: Samara
country: Russian Federation
facility: SBEI HPE "Samara State Medical University" of the MoH of the RF
city: Belfast
country: United Kingdom
facility: Queens University Belfast
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital, South Korea
name: Se Joon Woo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.