Age-Related Macular DegenerationPhase 3NCT03150589
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
A Phase 3 study testing SB11 (Proposed ranibizumab biosimilar) and Lucentis (ranibizumab) in people with Age-Related Macular Degeneration, run by Samsung Bioepis Co., Ltd. at 75 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- SB11 (Proposed ranibizumab biosimilar) and Lucentis (ranibizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 75 sitesin 9 countries
- Study dates
- 14 Mar 2018to 9 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
75 sites in 9 countries.
75 sites in 9 countries
United States19 sites
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701
Retina Research Institute of Texas
Abilene, Texas, 79606
Southeast Retina Center
Augusta, Georgia, 30909
Austin Restina Associates
Austin, Texas, 78705
Retina Center of New Jersey, LLC
Bloomfield, New Jersey, 07003
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
Retina consultants of Houston
Conroe, Texas, 77030
Retina Consultants
Fort Myers, Florida, 33912
LIVR
Great Neck, New York, 11021
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11788
Retina Consultants of Houston
Houston, Texas, 77030
Raj K. Maturi, MD, PC
Indianapolis, Indiana, 46280
Charleston Neuroscience Institute
Ladson, South Carolina, 29414
Retina Associates of Cleveland
Middleburg Heights, Ohio, 44130
Retina consultants San Diego
Poway, California, 92064
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Retina Associates of Western NY
Rochester, New York, 14620
Retina Vitreous Surgeons fo Central NY, PC
Syracuse, New York, 13224
NJ Retina
Toms River, New Jersey, 08755-8063
Germany10 sites
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
Augenärzte am St. Franziskus-Hospital Münster
Münster, Munster
MVZ ADTC Siegburg GmbH
Siegburg
University of Tuebingen STZ eyetrial at the Department of Ophthalmology
Tübingen
Hungary10 sites
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
Ganglion Orvosi Kozpont
Pécs, Pecs
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
Markusovszky Egyetemi Oktatokorhaz
Szombathely
Poland7 sites
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
Centrum Medyczne UNO-MED.
Tarnów, Tarnow
Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
Wałbrzych, Walbrzych
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
Wroclaw, Wroclaw
South Korea7 sites
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
Czechia6 sites
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
India6 sites
Medilink Hospital
Ahmedabad
PGIMER
Chandigarh
Shankara Netralaya
Chennai
Aravind Eye Hospital
Coimbatore
Shroff eye Hospital
Mumbai
Regional Institute of Opthalmology
Trivandrum
Russia6 sites
"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
United Kingdom4 sites
Queens University Belfast
Belfast
Bristol Eye Hospital
Bristol
Frimley Park Hospital
Frimley
Moorfields Eye Hospital
London
About this study
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
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.
Read the 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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- SB11 (Proposed ranibizumab biosimilar), Lucentis (ranibizumab)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB11 (Proposed ranibizumab biosimilar)Drug
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab)Drug
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| SB11 (Proposed ranibizumab biosimilar) | Experimental | Not described Receives: Drug: SB11 (Proposed ranibizumab biosimilar) |
| Lucentis (ranibizumab) | Active comparator | Not described Receives: Drug: Lucentis (ranibizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA)
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Measured: Baseline and Week 8
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
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start14 Mar 2018
- Primary completion24 May 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Se Joon Woo, Principal investigator, Seoul National University Bundang Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150589
- Sponsor's protocol ID
- SB11-G31-AMD
- Status last verified
- Apr 2021
- First submitted
- 10 May 2017
- Last updated
- 21 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bressler NM, Kim T, Oh I, Russo P, Kim MY, Woo SJ. Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Feb 1;141(2):117-127. doi: 10.1001/jamaophthalmol.2022.5403.
PubMed 36520462Woo 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.
PubMed 33211076
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03150589
- Acronym / sponsor ID
- SB11-G31-AMD
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB11 (Proposed ranibizumab biosimilar) | Experimental | Drug: SB11 (Proposed ranibizumab biosimilar) |
| Lucentis (ranibizumab) | Active comparator | Drug: Lucentis (ranibizumab) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB11 (Proposed ranibizumab biosimilar)SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks | Drug | SB11 (Proposed ranibizumab biosimilar) |
| Lucentis (ranibizumab)Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks | Drug | Lucentis (ranibizumab) |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36520462Bressler NM, Kim T, Oh I, Russo P, Kim MY, Woo SJ. Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Feb 1;141(2):117-127. doi: 10.1001/jamaophthalmol.2022.5403.
- Derived from this study: PubMed 33211076Woo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se Joon Woo principal investigator
Seoul National University Bundang Hospital, South Korea
75 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB11 (Proposed ranibizumab biosimilar) and Lucentis (ranibizumab) in people with Age-Related Macular Degeneration, run by Samsung Bioepis Co., Ltd. at 75 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Germany, Hungary, Poland, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Best Corrected Visual Acuity (BCVA) (time frame: Baseline and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.