A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Sponsor
Samsung Bioepis Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03150589
Collaborator
(none)
705
75
2
20.9
9.4
0.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Type:
Interventional
Actual Enrollment
:
705 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Mar 14, 2018
Actual Primary Completion Date
:
May 24, 2019
Actual Study Completion Date
:
Dec 9, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SB11 (Proposed ranibizumab biosimilar)
|
Drug: SB11 (Proposed ranibizumab biosimilar)
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
| Active Comparator: Lucentis (ranibizumab)
|
Drug: Lucentis (ranibizumab)
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [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) [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retina consultants San Diego | Poway | California | United States | 92064 |
| 2 | Retina Consultants of Southern Colorado | Colorado Springs | Colorado | United States | 80909 |
| 3 | Retina Consultants | Fort Myers | Florida | United States | 33912 |
| 4 | Southeast Retina Center | Augusta | Georgia | United States | 30909 |
| 5 | Retina Consultants of Hawaii | 'Aiea | Hawaii | United States | 96701 |
| 6 | Raj K. Maturi, MD, PC | Indianapolis | Indiana | United States | 46280 |
| 7 | Retina Center of New Jersey, LLC | Bloomfield | New Jersey | United States | 07003 |
| 8 | NJ Retina | Toms River | New Jersey | United States | 08755-8063 |
| 9 | LIVR | Great Neck | New York | United States | 11021 |
| 10 | Long Island Vitreoretinal Consultants | Hauppauge | New York | United States | 11788 |
| 11 | Retina Associates of Western NY | Rochester | New York | United States | 14620 |
| 12 | Retina Vitreous Surgeons fo Central NY, PC | Syracuse | New York | United States | 13224 |
| 13 | Retina Associates of Cleveland | Middleburg Heights | Ohio | United States | 44130 |
| 14 | Charleston Neuroscience Institute | Ladson | South Carolina | United States | 29414 |
| 15 | Black Hills Regional Eye Institute | Rapid City | South Dakota | United States | 57701 |
| 16 | Retina Research Institute of Texas | Abilene | Texas | United States | 79606 |
| 17 | Austin Restina Associates | Austin | Texas | United States | 78705 |
| 18 | Retina consultants of Houston | Conroe | Texas | United States | 77030 |
| 19 | Retina Consultants of Houston | Houston | Texas | United States | 77030 |
| 20 | University Hospital Brno | Brno | Czechia | ||
| 21 | University Hospital Hradec Kralove | Hradec Králové | Czechia | ||
| 22 | University Hospital Olomouc | Olomouc | Czechia | ||
| 23 | University Hopsital Ostrava | Ostrava | Czechia | ||
| 24 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | ||
| 25 | Axon Clinical s.r.o. | Praha 5 | Czechia | ||
| 26 | Augenärzte am St. Franziskus-Hospital Münster | Münster | Munster | Germany | |
| 27 | Charite | Berlin | Germany | ||
| 28 | Universitaetsklinikum Bonn | Bonn | Germany | ||
| 29 | Klinikum Chemnitz gGmbH | Chemnitz | Germany | ||
| 30 | Uni Düsseldorf | Duesseldorf | Germany | ||
| 31 | University Medical Center, Freiburg | Freiburg | Germany | ||
| 32 | Uni Göttingen | Goettigen | Germany | ||
| 33 | TU Munich | Muenchen | Germany | ||
| 34 | MVZ ADTC Siegburg GmbH | Siegburg | Germany | ||
| 35 | University of Tuebingen STZ eyetrial at the Department of Ophthalmology | Tuebingen | Germany | ||
| 36 | Ganglion Orvosi Kozpont | Pécs | Pecs | Hungary | |
| 37 | Bajcsy-Zsilinszky Korhaz es Rendelointezet | Budapest | Hungary | ||
| 38 | Budapest Retina Associates Ltd. | Budapest | Hungary | ||
| 39 | Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest | Hungary | ||
| 40 | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | Hungary | ||
| 41 | Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont | Budapest | Hungary | ||
| 42 | Semmelweis Egyetem Szemeszeti Klinika | Budapest | Hungary | ||
| 43 | Debreceni Egyetem Klinikai Kozpont, Szemklinika | Debrecen | Hungary | ||
| 44 | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | Hungary | ||
| 45 | Markusovszky Egyetemi Oktatokorhaz | Szombathely | Hungary | ||
| 46 | Medilink Hospital | Ahmedabad | India | ||
| 47 | PGIMER | Chandigarh | India | ||
| 48 | Shankara Netralaya | Chennai | India | ||
| 49 | Aravind Eye Hospital | Coimbatore | India | ||
| 50 | Shroff eye Hospital | Mumbai | India | ||
| 51 | Regional Institute of Opthalmology | Trivandrum | India | ||
| 52 | Pusan National University Hospital | Busan | Korea, Republic of | ||
| 53 | Yeungnam University Hospital | Daegu | Korea, Republic of | ||
| 54 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | ||
| 55 | Asan Medical Center | Seoul | Korea, Republic of | ||
| 56 | Samsung Medical Center | Seoul | Korea, Republic of | ||
| 57 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
| 58 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | ||
| 59 | Centrum Medyczne UNO-MED. | Tarnów | Tarnow | Poland | |
| 60 | Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny | Wałbrzych | Walbrzych | Poland | |
| 61 | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki | Wrocław | Wroclaw | Poland | |
| 62 | Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz | Bydgoszcz | Poland | ||
| 63 | Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała | Katowice | Poland | ||
| 64 | Centrum Medyczne UNO-MED. | Kraków | Poland | ||
| 65 | Centrum Diagnostyki i Mikrochirurgii Oka LENS | Olsztyn | Poland | ||
| 66 | "State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan" | Kazan | Russian Federation | ||
| 67 | Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex | Moscow | Russian Federation | ||
| 68 | Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases" | Moscow | Russian Federation | ||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | SBEI HPE "Samara State Medical University" of the MoH of the RF | Samara | Russian Federation | ||
| 72 | Queens University Belfast | Belfast | United Kingdom | ||
| 73 | Bristol Eye Hospital | Bristol | United Kingdom | ||
| 74 | Frimley Park Hospital | Frimley | United Kingdom | ||
| 75 | Moorfields Eye Hospital | London | United Kingdom |
Sponsors and Collaborators
- Samsung Bioepis Co., Ltd.
Investigators
- Principal Investigator: Se Joon Woo, Seoul National University Bundang Hospital, South Korea
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03150589
Other Study ID Numbers:
- SB11-G31-AMD
First Posted:
May 12, 2017
Last Update Posted:
May 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) |
|---|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | ||
| STARTED | 351 | 354 |
| COMPLETED | 307 | 327 |
| NOT COMPLETED | 44 | 27 |
Baseline Characteristics
| Arm/Group Title | SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) | Total |
|---|---|---|---|
| Arm/Group Description | 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 | Total of all reporting groups |
| Overall Participants | 351 | 354 | 705 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
74.4
(8.00)
|
73.8
(8.92)
|
74.1
(8.48)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
202
57.5%
|
201
56.8%
|
403
57.2%
|
| Male |
149
42.5%
|
153
43.2%
|
302
42.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
51
14.5%
|
52
14.7%
|
103
14.6%
|
| Native Hawaiian or Other Pacific Islander |
1
0.3%
|
0
0%
|
1
0.1%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
297
84.6%
|
300
84.7%
|
597
84.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
0.6%
|
2
0.6%
|
4
0.6%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) |
|---|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 346 | 348 |
| Least Squares Mean (Standard Error) [letters] |
6.26
(0.51)
|
7.08
(0.51)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol Set for CST |
| Arm/Group Title | SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) |
|---|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 342 | 338 |
| Least Squares Mean (Standard Error) [μm] |
-108.40
(4.65)
|
-100.05
(4.64)
|
Adverse Events
| Time Frame | From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All AEs (ocular or non-ocular) were recorded. | |||
| Arm/Group Title | SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) | ||
| Arm/Group Description | 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 | ||
All Cause Mortality |
||||
| SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/350 (0%) | 0/354 (0%) | ||
Serious Adverse Events |
||||
| SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 52/350 (14.9%) | 52/354 (14.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Cardiac disorders | ||||
| Atrial fibrillation | 4/350 (1.1%) | 4 | 3/354 (0.8%) | 3 |
| Cardiac failure congestive | 2/350 (0.6%) | 2 | 2/354 (0.6%) | 2 |
| Angina pectoris | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Coronary artery disease | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Left ventricular failure | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Myocardial ischaemia | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Angina unstable | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Bradycardia | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Ear and labyrinth disorders | ||||
| Vestibular disorder | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Eye disorders | ||||
| Retinal haemorrhage | 3/350 (0.9%) | 4 | 1/354 (0.3%) | 1 |
| Cataract | 2/350 (0.6%) | 2 | 0/354 (0%) | 0 |
| Visual acuity reduced | 2/350 (0.6%) | 3 | 1/354 (0.3%) | 1 |
| Age-related macular degeneration | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Iridocyclitis | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Macular oedema | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Retinal pigment epithelial tear | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Subretinal fluid | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Uveitis | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Vitreous haemorrhage | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Vitritis | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Cataract subcapsular | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Choroidal neovascularisation | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Macular degeneration | 0/350 (0%) | 0 | 2/354 (0.6%) | 2 |
| Retinal artery occlusion | 0/350 (0%) | 0 | 2/354 (0.6%) | 2 |
| Gastrointestinal disorders | ||||
| Gastric ulcer haemorrhage | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Inguinal hernia | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Intra-abdominal haemorrhage | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Pancreatitis acute | 0/350 (0%) | 0 | 2/354 (0.6%) | 2 |
| Small intestinal obstruction | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| General disorders | ||||
| Death | 1/350 (0.3%) | 1 | 2/354 (0.6%) | 2 |
| Hepatobiliary disorders | ||||
| Bile duct stone | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Cholelithiasis | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Cholecystitis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Infections and infestations | ||||
| Endophthalmitis | 2/350 (0.6%) | 2 | 0/354 (0%) | 0 |
| Pneumonia | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Pneumonia bacterial | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Urinary tract infection | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Bacterial colitis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Cystitis | 0/350 (0%) | 0 | 2/354 (0.6%) | 2 |
| Diverticulitis intestinal haemorrhagic | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Hepatitis C | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Infection | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Meningitis aseptic | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Pulmonary tuberculosis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Sepsis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Anaemia postoperative | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Ankle fracture | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Femoral neck fracture | 1/350 (0.3%) | 1 | 2/354 (0.6%) | 2 |
| Hand fracture | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Humerus fracture | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Pneumothorax traumatic | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Postoperative ileus | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Joint dislocation | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Lower limb fracture | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Radius fracture | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Spinal compression fracture | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Subdural haematoma | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Upper limb fracture | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Spinal osteoarthritis | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Arthralgia | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Back pain | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Myalgia | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Neck pain | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Chronic lymphocytic leukaemia | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Colon cancer | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Endometrial adenocarcinoma | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Lung adenocarcinoma | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Mantle cell lymphoma | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Pancreatic carcinoma | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Prostate cancer | 1/350 (0.3%) | 1 | 1/354 (0.3%) | 1 |
| Schwannoma | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Squamous cell carcinoma of lung | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Uterine cancer | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Breast cancer female | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Plasma cell myeloma | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Nervous system disorders | ||||
| Cerebral circulatory failure | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Cerebral haemorrhage | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Syncope | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 3/350 (0.9%) | 3 | 1/354 (0.3%) | 1 |
| Renal colic | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Calculus bladder | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Nephrolithiasis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Renal artery stenosis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Urethral stenosis | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Metrorrhagia | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 2/350 (0.6%) | 2 | 0/354 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Rash | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
| Vascular disorders | ||||
| Hypertension | 3/350 (0.9%) | 3 | 0/354 (0%) | 0 |
| Aortic aneurysm | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Iliac artery embolism | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Peripheral ischaemia | 1/350 (0.3%) | 1 | 0/354 (0%) | 0 |
| Haematoma | 0/350 (0%) | 0 | 1/354 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| SB11 (Proposed Ranibizumab Biosimilar) | Lucentis (Ranibizumab) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 111/350 (31.7%) | 126/354 (35.6%) | ||
| Eye disorders | ||||
| Neovascular age-related macular degeneration | 26/350 (7.4%) | 26 | 24/354 (6.8%) | 24 |
| Visual acuity reduced | 21/350 (6%) | 27 | 23/354 (6.5%) | 31 |
| Conjunctival haemorrhage | 19/350 (5.4%) | 23 | 19/354 (5.4%) | 21 |
| Infections and infestations | ||||
| Nasopharyngitis | 39/350 (11.1%) | 44 | 36/354 (10.2%) | 41 |
| Investigations | ||||
| Intraocular pressure increased | 24/350 (6.9%) | 47 | 29/354 (8.2%) | 77 |
| Vascular disorders | ||||
| Hypertension | 17/350 (4.9%) | 18 | 28/354 (7.9%) | 39 |
Limitations/Caveats
Investigator agree to submit any proposed publication/presentation to Sponsor for review at least sixty days prior to submitting any such proposed publication to a publisher or proceeding with such proposed presentation.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | Samsung Bioepis Co., Ltd |
| Phone | +82-32-728-0371 |
| sbregistry@samsung.com |
Responsible Party:
Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03150589
Other Study ID Numbers:
- SB11-G31-AMD
First Posted:
May 12, 2017
Last Update Posted:
May 21, 2021
Last Verified:
Apr 1, 2021