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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150589
• Other study ID #: SB11-G31-AMD
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

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