A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- Conditions
- Age-Related Macular Degeneration
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 705
- 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
- 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Retina Vitreous Surgeons fo Central NY, PC
🇺🇸Syracuse, New York, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
🇵🇱Wrocław, Wroclaw, Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
🇵🇱Olsztyn, Poland
Retina Associates of Cleveland
🇺🇸Middleburg Heights, Ohio, United States
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases"
🇷🇺Moscow, Russian Federation
Frimley Park Hospital
🇬🇧Frimley, United Kingdom
Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała
🇵🇱Katowice, Poland
Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex
🇷🇺Moscow, Russian Federation
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, Russian Federation
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Queens University Belfast
🇬🇧Belfast, United Kingdom
Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
🇵🇱Wałbrzych, Walbrzych, Poland
Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz
🇵🇱Bydgoszcz, Poland
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, Russian Federation
Moorfields Eye Hospital
🇬🇧London, United Kingdom
SBEI HPE "Samara State Medical University" of the MoH of the RF
🇷🇺Samara, Russian Federation
Raj K. Maturi, MD, PC
🇺🇸Indianapolis, Indiana, United States
Retina Consultants of Houston
🇺🇸Houston, Texas, United States
Retina consultants San Diego
🇺🇸Poway, California, United States
Retina Consultants of Hawaii
🇺🇸'Aiea, Hawaii, United States
Retina Associates of Western NY
🇺🇸Rochester, New York, United States
LIVR
🇺🇸Great Neck, New York, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Augenärzte am St. Franziskus-Hospital Münster
🇩🇪Münster, Munster, Germany
Axon Clinical s.r.o.
🇨🇿Praha 5, Czechia
Uni Düsseldorf
🇩🇪Duesseldorf, Germany
University Medical Center, Freiburg
🇩🇪Freiburg, Germany
University of Tuebingen STZ eyetrial at the Department of Ophthalmology
🇩🇪Tuebingen, Germany
TU Munich
🇩🇪Muenchen, Germany
MVZ ADTC Siegburg GmbH
🇩🇪Siegburg, Germany
Budapest Retina Associates Ltd.
🇭🇺Budapest, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
🇭🇺Budapest, Hungary
Semmelweis Egyetem Szemeszeti Klinika
🇭🇺Budapest, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
Shankara Netralaya
🇮🇳Chennai, India
Aravind Eye Hospital
🇮🇳Coimbatore, India
Shroff eye Hospital
🇮🇳Mumbai, India
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
University Hospital Brno
🇨🇿Brno, Czechia
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
Retina Consultants
🇺🇸Fort Myers, Florida, United States
Austin Restina Associates
🇺🇸Austin, Texas, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Retina Center of New Jersey, LLC
🇺🇸Bloomfield, New Jersey, United States
University Hopsital Ostrava
🇨🇿Ostrava, Czechia
Markusovszky Egyetemi Oktatokorhaz
🇭🇺Szombathely, Hungary
NJ Retina
🇺🇸Toms River, New Jersey, United States
Long Island Vitreoretinal Consultants
🇺🇸Hauppauge, New York, United States
Uni Göttingen
🇩🇪Goettigen, Germany
Retina consultants of Houston
🇺🇸Conroe, Texas, United States
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Ganglion Orvosi Kozpont
🇭🇺Pécs, Pecs, Hungary
Charite
🇩🇪Berlin, Germany
Magyar Honvedseg Egeszsegugyi Kozpont
🇭🇺Budapest, Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Debreceni Egyetem Klinikai Kozpont, Szemklinika
🇭🇺Debrecen, Hungary
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
"State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan"
🇷🇺Kazan, Russian Federation
PGIMER
🇮🇳Chandigarh, India
Regional Institute of Opthalmology
🇮🇳Trivandrum, India
Medilink Hospital
🇮🇳Ahmedabad, India
Centrum Medyczne UNO-MED.
🇵🇱Kraków, Poland