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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03150589
Other study ID # SB11-G31-AMD
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 14, 2018
Est. completion date December 9, 2019

Study information

Verified date April 2021
Source Samsung Bioepis Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 705
Est. completion date December 9, 2019
Est. primary completion date May 24, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Czechia University Hospital Brno Brno
Czechia University Hospital Hradec Kralove Hradec Králové
Czechia University Hospital Olomouc Olomouc
Czechia University Hopsital Ostrava Ostrava
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Axon Clinical s.r.o. Praha 5
Germany Charite Berlin
Germany Universitaetsklinikum Bonn Bonn
Germany Klinikum Chemnitz gGmbH Chemnitz
Germany Uni Düsseldorf Duesseldorf
Germany University Medical Center, Freiburg Freiburg
Germany Uni Göttingen Goettigen
Germany TU Munich Muenchen
Germany Augenärzte am St. Franziskus-Hospital Münster Münster Munster
Germany MVZ ADTC Siegburg GmbH Siegburg
Germany University of Tuebingen STZ eyetrial at the Department of Ophthalmology Tuebingen
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 Ganglion Orvosi Kozpont Pécs Pecs
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged
Hungary Markusovszky Egyetemi Oktatokorhaz Szombathely
India 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
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Poland Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz Bydgoszcz
Poland Specjalistyczna Praktyka Lekarska Prof. E. Wylegala Katowice
Poland Centrum Medyczne UNO-MED. Kraków
Poland Centrum Diagnostyki i Mikrochirurgii Oka LENS Olsztyn
Poland Centrum Medyczne UNO-MED. Tarnów Tarnow
Poland Szpital Specjalistyczny im Sokolowskiego Oddzial Okulistyczny Walbrzych Walbrzych
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki Wroclaw Wroclaw
Russian Federation "State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan" Kazan
Russian Federation Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex Moscow
Russian Federation Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases" Moscow
Russian Federation 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 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 SBEI HPE "Samara State Medical University" of the MoH of the RF Samara
United Kingdom Queens University Belfast Belfast
United Kingdom Bristol Eye Hospital Bristol
United Kingdom Frimley Park Hospital Frimley
United Kingdom Moorfields Eye Hospital London
United States Retina Consultants of Hawaii 'Aiea Hawaii
United States Retina Research Institute of Texas Abilene Texas
United States Southeast Retina Center Augusta Georgia
United States Austin Restina Associates Austin Texas
United States Retina Center of New Jersey, LLC Bloomfield New Jersey
United States Retina Consultants of Southern Colorado Colorado Springs Colorado
United States Retina consultants of Houston Conroe Texas
United States Retina Consultants Fort Myers Florida
United States LIVR Great Neck New York
United States Long Island Vitreoretinal Consultants Hauppauge New York
United States Retina Consultants of Houston Houston Texas
United States Raj K. Maturi, MD, PC Indianapolis Indiana
United States Charleston Neuroscience Institute Ladson South Carolina
United States Retina Associates of Cleveland Middleburg Heights Ohio
United States Retina consultants San Diego Poway California
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Retina Associates of Western NY Rochester New York
United States Retina Vitreous Surgeons fo Central NY, PC Syracuse New York
United States NJ Retina Toms River New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Hungary,  India,  Korea, Republic of,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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