A Study to Compare SB11 (Proposed Ranibizumab Biosimilar)... | NCT03150589

NCT03150589

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SB11 (Proposed ranibizumab biosimilar)	Experimental		Drug: SB11 (Proposed ranibizumab biosimilar)
Lucentis (ranibizumab)	Active Comparator		Drug: Lucentis (ranibizumab)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SB11 (Proposed ranibizumab biosimilar)	Drug	SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks	SB11 (Proposed ranibizumab biosimilar)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Se Joon Woo	Seoul National University Bundang Hospital, South Korea	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Retina consultants San Diego		Poway	California	92064	United States
Retina Consultants of Southern Colorado

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36520462	Derived	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.
33211076

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SB11 (Proposed Ranibizumab Biosimilar)	SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
FG001	Lucentis (Ranibizumab)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 1, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	SB11 (Proposed Ranibizumab Biosimilar)	SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
BG001	Lucentis (Ranibizumab)	Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00074.4± 8.00 BG00173.8± 8.92 BG00274.1± 8.48

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000202 BG001201 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Best Corrected Visual Acuity (BCVA)

The VA was assessed using original series ETDRS charts or 2702 series number charts.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

letters

Baseline and Week 8

ID	Title	Description
OG000	SB11 (Proposed Ranibizumab Biosimilar)	SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
OG001	Lucentis (Ranibizumab)	Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

Units	Counts
Participants	OG000346 OG001348

Title

Denominators

Categories

Title	Measurements
	OG0006.26± 0.51 OG0017.08± 0.51

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

Per-Protocol Set for CST

Posted

Least Squares Mean

Standard Error

μm

Baseline and Week 4

ID	Title	Description
OG000	SB11 (Proposed Ranibizumab Biosimilar)	SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
OG001	Lucentis (Ranibizumab)	Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SB11 (Proposed Ranibizumab Biosimilar)	SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks	0	350	52	350	111	350
EG001	Lucentis (Ranibizumab)	Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks	0	354	52	354	126	354

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0004 events4 affected350 at risk EG0013 events3 affected354 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0002 events2 affected350 at risk EG0012 events2 affected354 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Left ventricular failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Angina unstable	Cardiac disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Vestibular disorder	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Retinal haemorrhage	Eye disorders	Systematic Assessment	EG0004 events3 affected350 at risk EG0011 events1 affected354 at risk
Cataract	Eye disorders	Systematic Assessment	EG0002 events2 affected350 at risk EG0010 events0 affected354 at risk
Visual acuity reduced	Eye disorders	Systematic Assessment	EG0003 events2 affected350 at risk EG0011 events1 affected354 at risk
Age-related macular degeneration	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Iridocyclitis	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Macular oedema	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Retinal pigment epithelial tear	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Subretinal fluid	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Uveitis	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Vitreous haemorrhage	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Vitritis	Eye disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Cataract subcapsular	Eye disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Choroidal neovascularisation	Eye disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Macular degeneration	Eye disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0012 events2 affected354 at risk
Retinal artery occlusion	Eye disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0012 events2 affected354 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0012 events2 affected354 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Death	General disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0012 events2 affected354 at risk
Bile duct stone	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Endophthalmitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected350 at risk EG0010 events0 affected354 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Bacterial colitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Cystitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0012 events2 affected354 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Hepatitis C	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Meningitis aseptic	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Pulmonary tuberculosis	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Ankle fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0012 events2 affected354 at risk
Hand fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Humerus fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Postoperative ileus	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Joint dislocation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Lower limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Radius fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Upper limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0011 events1 affected354 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Cerebral circulatory failure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected350 at risk EG0011 events1 affected354 at risk
Renal colic	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Calculus bladder	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Renal artery stenosis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Urethral stenosis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Metrorrhagia	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected350 at risk EG0010 events0 affected354 at risk
Angioedema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0003 events3 affected350 at risk EG0010 events0 affected354 at risk
Aortic aneurysm	Vascular disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Iliac artery embolism	Vascular disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Peripheral ischaemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected350 at risk EG0010 events0 affected354 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected350 at risk EG0011 events1 affected354 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Neovascular age-related macular degeneration	Eye disorders	Systematic Assessment	EG00026 events26 affected350 at risk EG00124 events24 affected354 at risk
Visual acuity reduced	Eye disorders	Systematic Assessment	EG00027 events21 affected350 at risk EG00131 events23 affected354 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG00023 events19 affected350 at risk EG00121 events19 affected354 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG00044 events39 affected350 at risk EG00141 events36 affected354 at risk
Intraocular pressure increased	Investigations	Systematic Assessment	EG00047 events24 affected350 at risk EG00177 events29 affected354 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG00018 events17 affected350 at risk EG00139 events28 affected354 at risk

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.

Certain Agreements

ID	Term
D008268	Macular Degeneration

ID	Term
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases