Back to resultsA Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SB11 (Proposed ranibizumab biosimilar)
Lucentis (ranibizumab)
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Retina consultants San Diego
- Retina Consultants of Southern Colorado
- Retina Consultants
- Southeast Retina Center
- Retina Consultants of Hawaii
- Raj K. Maturi, MD, PC
- Retina Center of New Jersey, LLC
- NJ Retina
- LIVR
- Long Island Vitreoretinal Consultants
- Retina Associates of Western NY
- Retina Vitreous Surgeons fo Central NY, PC
- Retina Associates of Cleveland
- Charleston Neuroscience Institute
- Black Hills Regional Eye Institute
- Retina Research Institute of Texas
- Austin Restina Associates
- Retina consultants of Houston
- Retina Consultants of Houston
- University Hospital Brno
- University Hospital Hradec Kralove
- University Hospital Olomouc
- University Hopsital Ostrava
- Fakultni nemocnice Kralovske Vinohrady
- Axon Clinical s.r.o.
- Augenärzte am St. Franziskus-Hospital Münster
- Charite
- Universitaetsklinikum Bonn
- Klinikum Chemnitz gGmbH
- Uni Düsseldorf
- University Medical Center, Freiburg
- Uni Göttingen
- TU Munich
- MVZ ADTC Siegburg GmbH
- University of Tuebingen STZ eyetrial at the Department of Ophthalmology
- Ganglion Orvosi Kozpont
- Bajcsy-Zsilinszky Korhaz es Rendelointezet
- Budapest Retina Associates Ltd.
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet
- Magyar Honvedseg Egeszsegugyi Kozpont
- Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
- Semmelweis Egyetem Szemeszeti Klinika
- Debreceni Egyetem Klinikai Kozpont, Szemklinika
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
- Markusovszky Egyetemi Oktatokorhaz
- Medilink Hospital
- PGIMER
- Shankara Netralaya
- Aravind Eye Hospital
- Shroff eye Hospital
- Regional Institute of Opthalmology
- Pusan National University Hospital
- Yeungnam University Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Hospital
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Centrum Medyczne UNO-MED.
- Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
- Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz
- Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała
- Centrum Medyczne UNO-MED.
- Centrum Diagnostyki i Mikrochirurgii Oka LENS
- "State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan"
- Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex
- Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases"
- Federal State Autonomous Institution "Intersectoral research and technical complex "Eye Microsurgery" named after acad. S.N. Fyodorov" of Ministry of Health of 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
- SBEI HPE "Samara State Medical University" of the MoH of the RF
- Queens University Belfast
- Bristol Eye Hospital
- Frimley Park Hospital
- Moorfields Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SB11 (Proposed ranibizumab biosimilar)
Lucentis (ranibizumab)
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA)
The VA was assessed using original series ETDRS charts or 2702 series number charts.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03150589
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
May 24, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Bioepis Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
705 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SB11 (Proposed ranibizumab biosimilar)
Arm Type
Experimental
Arm Title
Lucentis (ranibizumab)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SB11 (Proposed ranibizumab biosimilar)
Intervention Description
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Lucentis (ranibizumab)
Intervention Description
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Description
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Time Frame
Baseline and Week 8
Title
Change From Baseline in Central Subfield Thickness (CST)
Description
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Joon Woo
Organizational Affiliation
Seoul National University Bundang Hospital, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Retina Consultants of Southern Colorado
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Retina Consultants
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Raj K. Maturi, MD, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Retina Center of New Jersey, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
NJ Retina
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-8063
Country
United States
Facility Name
LIVR
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
Retina Associates of Western NY
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Retina Vitreous Surgeons fo Central NY, PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Retina Associates of Cleveland
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Restina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina consultants of Houston
City
Conroe
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Hospital Brno
City
Brno
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
Country
Czechia
Facility Name
University Hopsital Ostrava
City
Ostrava
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
Country
Czechia
Facility Name
Axon Clinical s.r.o.
City
Praha 5
Country
Czechia
Facility Name
Augenärzte am St. Franziskus-Hospital Münster
City
Münster
State/Province
Munster
Country
Germany
Facility Name
Charite
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
Country
Germany
Facility Name
Uni Düsseldorf
City
Duesseldorf
Country
Germany
Facility Name
University Medical Center, Freiburg
City
Freiburg
Country
Germany
Facility Name
Uni Göttingen
City
Goettigen
Country
Germany
Facility Name
TU Munich
City
Muenchen
Country
Germany
Facility Name
MVZ ADTC Siegburg GmbH
City
Siegburg
Country
Germany
Facility Name
University of Tuebingen STZ eyetrial at the Department of Ophthalmology
City
Tuebingen
Country
Germany
Facility Name
Ganglion Orvosi Kozpont
City
Pécs
State/Province
Pecs
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Korhaz es Rendelointezet
City
Budapest
Country
Hungary
Facility Name
Budapest Retina Associates Ltd.
City
Budapest
Country
Hungary
Facility Name
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
City
Budapest
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
Country
Hungary
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem Szemeszeti Klinika
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Szemklinika
City
Debrecen
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
Country
Hungary
Facility Name
Medilink Hospital
City
Ahmedabad
Country
India
Facility Name
PGIMER
City
Chandigarh
Country
India
Facility Name
Shankara Netralaya
City
Chennai
Country
India
Facility Name
Aravind Eye Hospital
City
Coimbatore
Country
India
Facility Name
Shroff eye Hospital
City
Mumbai
Country
India
Facility Name
Regional Institute of Opthalmology
City
Trivandrum
Country
India
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Centrum Medyczne UNO-MED.
City
Tarnów
State/Province
Tarnow
Country
Poland
Facility Name
Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
City
Wałbrzych
State/Province
Walbrzych
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
City
Wrocław
State/Province
Wroclaw
Country
Poland
Facility Name
Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz
City
Bydgoszcz
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała
City
Katowice
Country
Poland
Facility Name
Centrum Medyczne UNO-MED.
City
Kraków
Country
Poland
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka LENS
City
Olsztyn
Country
Poland
Facility Name
"State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan"
City
Kazan
Country
Russian Federation
Facility Name
Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex
City
Moscow
Country
Russian Federation
Facility Name
Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases"
City
Moscow
Country
Russian Federation
Facility Name
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
Novosibirsk
Country
Russian Federation
Facility Name
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
Saint Petersburg
Country
Russian Federation
Facility Name
SBEI HPE "Samara State Medical University" of the MoH of the RF
City
Samara
Country
Russian Federation
Facility Name
Queens University Belfast
City
Belfast
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33211076
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.
Results Reference
derived
Learn more about this trial
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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