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

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ClinicalTrials.gov Identifier: NCT03150589
Recruitment Status : Completed
First Posted : May 12, 2017
Results First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Interventions Drug: SB11 (Proposed ranibizumab biosimilar)
Drug: Lucentis (ranibizumab)
Enrollment 705
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB11 (Proposed Ranibizumab Biosimilar) Lucentis (Ranibizumab)
Hide 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
Reason Not Completed
Withdrawal by Subject             16             9
Adverse Event             7             6
Protocol Violation             4             3
Lost to Follow-up             3             3
Death             2             3
IP non-compliance and other reasons             12             3
Arm/Group Title SB11 (Proposed Ranibizumab Biosimilar) Lucentis (Ranibizumab) Total
Hide 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 Number of Baseline Participants 351 354 705
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 351 participants 354 participants 705 participants
74.4  (8.00) 73.8  (8.92) 74.1  (8.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 354 participants 705 participants
Female
202
  57.5%
201
  56.8%
403
  57.2%
Male
149
  42.5%
153
  43.2%
302
  42.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 354 participants 705 participants
American Indian or Alaska Native
0
   0.0%
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
   0.0%
1
   0.1%
Black or African American
0
   0.0%
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%
0
   0.0%
Unknown or Not Reported
2
   0.6%
2
   0.6%
4
   0.6%
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA)
Hide Description The VA was assessed using original series ETDRS charts or 2702 series number charts.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SB11 (Proposed Ranibizumab Biosimilar) Lucentis (Ranibizumab)
Hide 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
Overall Number of Participants Analyzed 346 348
Least Squares Mean (Standard Error)
Unit of Measure: letters
6.26  (0.51) 7.08  (0.51)
2.Primary Outcome
Title Change From Baseline in Central Subfield Thickness (CST)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set for CST
Arm/Group Title SB11 (Proposed Ranibizumab Biosimilar) Lucentis (Ranibizumab)
Hide 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
Overall Number of Participants Analyzed 342 338
Least Squares Mean (Standard Error)
Unit of Measure: μm
-108.40  (4.65) -100.05  (4.64)
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)
Hide 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 (%) Affected / at Risk (%)
Total   0/350 (0.00%)      0/354 (0.00%)    
Hide Serious Adverse Events
SB11 (Proposed Ranibizumab Biosimilar) Lucentis (Ranibizumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/350 (14.86%)      52/354 (14.69%)    
Blood and lymphatic system disorders     
Anaemia   1/350 (0.29%)  1 1/354 (0.28%)  1
Cardiac disorders     
Atrial fibrillation   4/350 (1.14%)  4 3/354 (0.85%)  3
Cardiac failure congestive   2/350 (0.57%)  2 2/354 (0.56%)  2
Angina pectoris   1/350 (0.29%)  1 1/354 (0.28%)  1
Coronary artery disease   1/350 (0.29%)  1 0/354 (0.00%)  0
Left ventricular failure   1/350 (0.29%)  1 0/354 (0.00%)  0
Myocardial ischaemia   1/350 (0.29%)  1 0/354 (0.00%)  0
Angina unstable   0/350 (0.00%)  0 1/354 (0.28%)  1
Bradycardia   0/350 (0.00%)  0 1/354 (0.28%)  1
Ear and labyrinth disorders     
Vestibular disorder   1/350 (0.29%)  1 0/354 (0.00%)  0
Eye disorders     
Retinal haemorrhage   3/350 (0.86%)  4 1/354 (0.28%)  1
Cataract   2/350 (0.57%)  2 0/354 (0.00%)  0
Visual acuity reduced   2/350 (0.57%)  3 1/354 (0.28%)  1
Age-related macular degeneration   1/350 (0.29%)  1 0/354 (0.00%)  0
Iridocyclitis   1/350 (0.29%)  1 0/354 (0.00%)  0
Macular oedema   1/350 (0.29%)  1 1/354 (0.28%)  1
Retinal pigment epithelial tear   1/350 (0.29%)  1 0/354 (0.00%)  0
Subretinal fluid   1/350 (0.29%)  1 1/354 (0.28%)  1
Uveitis   1/350 (0.29%)  1 0/354 (0.00%)  0
Vitreous haemorrhage   1/350 (0.29%)  1 0/354 (0.00%)  0
Vitritis   1/350 (0.29%)  1 0/354 (0.00%)  0
Cataract subcapsular   0/350 (0.00%)  0 1/354 (0.28%)  1
Choroidal neovascularisation   0/350 (0.00%)  0 1/354 (0.28%)  1
Macular degeneration   0/350 (0.00%)  0 2/354 (0.56%)  2
Retinal artery occlusion   0/350 (0.00%)  0 2/354 (0.56%)  2
Gastrointestinal disorders     
Gastric ulcer haemorrhage   0/350 (0.00%)  0 1/354 (0.28%)  1
Inguinal hernia   0/350 (0.00%)  0 1/354 (0.28%)  1
Intra-abdominal haemorrhage   0/350 (0.00%)  0 1/354 (0.28%)  1
Pancreatitis acute   0/350 (0.00%)  0 2/354 (0.56%)  2
Small intestinal obstruction   0/350 (0.00%)  0 1/354 (0.28%)  1
General disorders     
Death   1/350 (0.29%)  1 2/354 (0.56%)  2
Hepatobiliary disorders     
Bile duct stone   1/350 (0.29%)  1 0/354 (0.00%)  0
Cholelithiasis   1/350 (0.29%)  1 1/354 (0.28%)  1
Cholecystitis   0/350 (0.00%)  0 1/354 (0.28%)  1
Infections and infestations     
Endophthalmitis   2/350 (0.57%)  2 0/354 (0.00%)  0
Pneumonia   1/350 (0.29%)  1 1/354 (0.28%)  1
Pneumonia bacterial   1/350 (0.29%)  1 0/354 (0.00%)  0
Urinary tract infection   1/350 (0.29%)  1 1/354 (0.28%)  1
Bacterial colitis   0/350 (0.00%)  0 1/354 (0.28%)  1
Cystitis   0/350 (0.00%)  0 2/354 (0.56%)  2
Diverticulitis intestinal haemorrhagic   0/350 (0.00%)  0 1/354 (0.28%)  1
Hepatitis C   0/350 (0.00%)  0 1/354 (0.28%)  1
Infection   0/350 (0.00%)  0 1/354 (0.28%)  1
Meningitis aseptic   0/350 (0.00%)  0 1/354 (0.28%)  1
Pulmonary tuberculosis   0/350 (0.00%)  0 1/354 (0.28%)  1
Sepsis   0/350 (0.00%)  0 1/354 (0.28%)  1
Injury, poisoning and procedural complications     
Anaemia postoperative   1/350 (0.29%)  1 0/354 (0.00%)  0
Ankle fracture   1/350 (0.29%)  1 0/354 (0.00%)  0
Femoral neck fracture   1/350 (0.29%)  1 2/354 (0.56%)  2
Hand fracture   1/350 (0.29%)  1 0/354 (0.00%)  0
Humerus fracture   1/350 (0.29%)  1 0/354 (0.00%)  0
Pneumothorax traumatic   1/350 (0.29%)  1 0/354 (0.00%)  0
Postoperative ileus   1/350 (0.29%)  1 0/354 (0.00%)  0
Joint dislocation   0/350 (0.00%)  0 1/354 (0.28%)  1
Lower limb fracture   0/350 (0.00%)  0 1/354 (0.28%)  1
Radius fracture   0/350 (0.00%)  0 1/354 (0.28%)  1
Spinal compression fracture   0/350 (0.00%)  0 1/354 (0.28%)  1
Subdural haematoma   0/350 (0.00%)  0 1/354 (0.28%)  1
Upper limb fracture   0/350 (0.00%)  0 1/354 (0.28%)  1
Metabolism and nutrition disorders     
Dehydration   1/350 (0.29%)  1 0/354 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis   1/350 (0.29%)  1 0/354 (0.00%)  0
Arthralgia   0/350 (0.00%)  0 1/354 (0.28%)  1
Back pain   0/350 (0.00%)  0 1/354 (0.28%)  1
Myalgia   0/350 (0.00%)  0 1/354 (0.28%)  1
Neck pain   0/350 (0.00%)  0 1/354 (0.28%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic lymphocytic leukaemia   1/350 (0.29%)  1 0/354 (0.00%)  0
Colon cancer   1/350 (0.29%)  1 0/354 (0.00%)  0
Endometrial adenocarcinoma   1/350 (0.29%)  1 0/354 (0.00%)  0
Lung adenocarcinoma   1/350 (0.29%)  1 0/354 (0.00%)  0
Mantle cell lymphoma   1/350 (0.29%)  1 0/354 (0.00%)  0
Pancreatic carcinoma   1/350 (0.29%)  1 0/354 (0.00%)  0
Prostate cancer   1/350 (0.29%)  1 1/354 (0.28%)  1
Schwannoma   1/350 (0.29%)  1 0/354 (0.00%)  0
Squamous cell carcinoma of lung   1/350 (0.29%)  1 0/354 (0.00%)  0
Uterine cancer   1/350 (0.29%)  1 0/354 (0.00%)  0
Breast cancer female   0/350 (0.00%)  0 1/354 (0.28%)  1
Plasma cell myeloma   0/350 (0.00%)  0 1/354 (0.28%)  1
Nervous system disorders     
Cerebral circulatory failure   1/350 (0.29%)  1 0/354 (0.00%)  0
Cerebral haemorrhage   1/350 (0.29%)  1 0/354 (0.00%)  0
Syncope   1/350 (0.29%)  1 0/354 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury   3/350 (0.86%)  3 1/354 (0.28%)  1
Renal colic   1/350 (0.29%)  1 0/354 (0.00%)  0
Calculus bladder   0/350 (0.00%)  0 1/354 (0.28%)  1
Nephrolithiasis   0/350 (0.00%)  0 1/354 (0.28%)  1
Renal artery stenosis   0/350 (0.00%)  0 1/354 (0.28%)  1
Urethral stenosis   0/350 (0.00%)  0 1/354 (0.28%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia   0/350 (0.00%)  0 1/354 (0.28%)  1
Metrorrhagia   0/350 (0.00%)  0 1/354 (0.28%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   2/350 (0.57%)  2 0/354 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema   0/350 (0.00%)  0 1/354 (0.28%)  1
Rash   0/350 (0.00%)  0 1/354 (0.28%)  1
Vascular disorders     
Hypertension   3/350 (0.86%)  3 0/354 (0.00%)  0
Aortic aneurysm   1/350 (0.29%)  1 0/354 (0.00%)  0
Iliac artery embolism   1/350 (0.29%)  1 0/354 (0.00%)  0
Peripheral ischaemia   1/350 (0.29%)  1 0/354 (0.00%)  0
Haematoma   0/350 (0.00%)  0 1/354 (0.28%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SB11 (Proposed Ranibizumab Biosimilar) Lucentis (Ranibizumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   111/350 (31.71%)      126/354 (35.59%)    
Eye disorders     
Neovascular age-related macular degeneration   26/350 (7.43%)  26 24/354 (6.78%)  24
Visual acuity reduced   21/350 (6.00%)  27 23/354 (6.50%)  31
Conjunctival haemorrhage   19/350 (5.43%)  23 19/354 (5.37%)  21
Infections and infestations     
Nasopharyngitis   39/350 (11.14%)  44 36/354 (10.17%)  41
Investigations     
Intraocular pressure increased   24/350 (6.86%)  47 29/354 (8.19%)  77
Vascular disorders     
Hypertension   17/350 (4.86%)  18 28/354 (7.91%)  39
Indicates events were collected by systematic assessment
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
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Samsung Bioepis Co., Ltd
Phone: +82-32-728-0371
EMail: sbregistry@samsung.com
Layout table for additonal information
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03150589    
Other Study ID Numbers: SB11-G31-AMD
First Submitted: May 10, 2017
First Posted: May 12, 2017
Results First Submitted: April 29, 2021
Results First Posted: May 21, 2021
Last Update Posted: May 21, 2021