A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

PHASE3CompletedINTERVENTIONAL
Enrollment

705

Participants

Timeline

Start Date

March 14, 2018

Primary Completion Date

May 24, 2019

Study Completion Date

December 9, 2019

Conditions
Age-Related Macular Degeneration
Interventions
DRUG

SB11 (Proposed ranibizumab biosimilar)

SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks

DRUG

Lucentis (ranibizumab)

Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

Trial Locations (75)

11021

LIVR, Great Neck

11788

Long Island Vitreoretinal Consultants, Hauppauge

13224

Retina Vitreous Surgeons fo Central NY, PC, Syracuse

14620

Retina Associates of Western NY, Rochester

29414

Charleston Neuroscience Institute, Ladson

30909

Southeast Retina Center, Augusta

33912

Retina Consultants, Fort Myers

44130

Retina Associates of Cleveland, Middleburg Heights

46280

Raj K. Maturi, MD, PC, Indianapolis

57701

Black Hills Regional Eye Institute, Rapid City

77030

Retina consultants of Houston, Conroe

Retina Consultants of Houston, Houston

78705

Austin Restina Associates, Austin

79606

Retina Research Institute of Texas, Abilene

80909

Retina Consultants of Southern Colorado, Colorado Springs

92064

Retina consultants San Diego, Poway

96701

Retina Consultants of Hawaii, ‘Aiea

07003

Retina Center of New Jersey, LLC, Bloomfield

08755-8063

NJ Retina, Toms River

Unknown

University Hospital Brno, Brno

University Hospital Hradec Kralove, Hradec Králové

University Hospital Olomouc, Olomouc

University Hopsital Ostrava, Ostrava

Axon Clinical s.r.o., Prague

Fakultni nemocnice Kralovske Vinohrady, Prague

Augenärzte am St. Franziskus-Hospital Münster, Münster

Charite, Berlin

Universitaetsklinikum Bonn, Bonn

Klinikum Chemnitz gGmbH, Chemnitz

Uni Düsseldorf, Düsseldorf

University Medical Center, Freiburg, Freiburg im Breisgau

Uni Göttingen, Goettigen

TU Munich, München

MVZ ADTC Siegburg GmbH, Siegburg

University of Tuebingen STZ eyetrial at the Department of Ophthalmology, Tübingen

Ganglion Orvosi Kozpont, Pécs

Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

Budapest Retina Associates Ltd., Budapest

Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Budapest

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Budapest

Semmelweis Egyetem Szemeszeti Klinika, Budapest

Debreceni Egyetem Klinikai Kozpont, Szemklinika, Debrecen

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

Markusovszky Egyetemi Oktatokorhaz, Szombathely

Medilink Hospital, Ahmedabad

PGIMER, Chandigarh

Shankara Netralaya, Chennai

Aravind Eye Hospital, Coimbatore

Shroff eye Hospital, Mumbai

Regional Institute of Opthalmology, Trivandrum

Centrum Medyczne UNO-MED., Tarnów

Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny, Wałbrzych

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki, Wroclaw

Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz, Bydgoszcz

Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała, Katowice

Centrum Medyczne UNO-MED., Krakow

Centrum Diagnostyki i Mikrochirurgii Oka LENS, Olsztyn

"State Autonomous Iinstitution of Healthcare Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan", Kazan'

Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex, Moscow

"Federal State Budget Scientific Institution Scientific Research Institute of Eye Diseases", Moscow

"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

"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

"SBEI HPE Samara State Medical University of the MoH of the RF", Samara

Pusan National University Hospital, Busan

Yeungnam University Hospital, Daegu

Seoul National University Bundang Hospital, Seongnam-si

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

Queens University Belfast, Belfast

Bristol Eye Hospital, Bristol

Frimley Park Hospital, Frimley

Moorfields Eye Hospital, London

All Listed Sponsors
lead

Samsung Bioepis Co., Ltd.

INDUSTRY

NCT03150589 - A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD) | Biotech Hunter | Biotech Hunter