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CTRI Number  CTRI/2018/05/013650 [Registered on: 03/05/2018] Trial Registered Prospectively
Last Modified On: 11/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial study to compare the effects of two drugs SB11 (study drug) and Lucentis® in subjects who have age related loss of vision 
Scientific Title of Study   A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB11 (proposed ranibizumab biosimilar) and Lucentis® in Subjects with Neovascular Age-related Macular Degeneration  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SB11-G31-AMD Amendment 1 dated 01 Sep 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Suneela Thatte  
Designation  VP Global Operations 
Affiliation  IQVIA RDS (India) Private Limited, Mumbai 
Address  IQVIA RDS (India) Private Limited, Mumbai Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station Andheri East, Mumbai

Mumbai
MAHARASHTRA
400069
India 
Phone  2266774242  
Fax  2266774343  
Email  suneela.thatte@quintiles.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Suneela Thatte  
Designation  VP Global Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited, Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station Andheri East, Mumbai

Mumbai
MAHARASHTRA
400069
India 
Phone  2266774242  
Fax  2266774343  
Email  suneela.thatte@quintiles.com  
 
Source of Monetary or Material Support  
Samsung Bioepis Co. Ltd  
 
Primary Sponsor  
Name  Samsung Bioepis Co Ltd 
Address  Samsung Bioepis Co. Ltd 107, Cheomdan-daero, Yeonsu-gu Incheon, 21987 Republic of Korea  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Quintiles Research India Private Limited  Quintiles Research (India) Private Limited, 2nd Floor, Etamin Block, Prestige Technology Park II, Sarjapur-Marathahalli Outer Ring Road, Bangalore-560103, Karnataka 
 
Countries of Recruitment     Czech Republic
Germany
Hungary
India
Poland
Republic of Korea
Russian Federation
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramandeep Singh   Advanced Eye Center, Postgraduate Institute of Medical Education and Research  Dept. Of Ophthalmology, Advanced Eye Center, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012
Jalandhar
PUNJAB 		 9463001620

mankoo95@yahoo.com 
Dr Narendran Venkatapathy   Aravind Eye Hospital  Avinahsi Road, Coimbatore, Dept: Retina and Vitreous clinic Postcode: 641014 Chief Medical officer room
Coimbatore
TAMIL NADU 		 914224360400
914222594344
narendran@cbe.aravind.org 
Dr Sahasranam Vasudeva Iyer   Regional Institute of Ophthalmology  Red Cross Road, Vanchiyoor. P Kerala- 695035 Dept: Opthalmology PI Room: Room no. 22
Thiruvananthapuram
KERALA 		 9104712304046

drsahasranamam@gmail.com 
Rohan Chauhan   Rising Retina Clinic  312 313, Iscon Centre Shivranjani Cross Roads
Ahmadabad
GUJARAT 		 917926925232
919727950600
rohan_28782@yahoo.com.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Human Ethics Committee, Regional Institute of Ophthalmology, Red Cross road, Vanchiyoor P.O, Thiruvananthapuram, Kerala-695035   Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12- 160012  Approved 
Medilinks Ethics Committe  Approved 
PSG Institute of Medical Sciences and Research, Peelamedu, Avinadhi Road, Coimbatore - 641004   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H353||Degeneration of macula and posterior pole, Subjects with Neovascular Age-Related Macular Degeneration ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lucentis  0.5 mg every 4 weeks, via intravitreal (ITV) Participants will be randomized to receive either; SB11 or Lucentis® Participants will be administered up to Week 48 and the last assessment will be done at Week 52.  
Intervention  SB11   0.5 mg every 4 weeks, via intravitreal (ITV)  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Age more than 50 years at Screening
2. Newly diagnosed, active subfoveal Choroidal Neovascularisation CNV lesion secondary to AMD in the study eye
Active CNV indicates presence of leakage and intra or sub retinal fluid which should be
confirmed by central reading centre during Screening
3. The area of CNV must occupy at least 50% of total lesion in the study eye confirmed by
central reading centre during Screening
4. Total lesion area less than 9.0 Disc Areas DA in size including blood, scars and neovascularisation in the study eye confirmed by central reading centre during Screening
5. Best Corrected Visual Acuity BCVA of 20/40 to 20/200 letter score of 73 to 34 using
original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series
Number charts in the study eye at Screening and at Week 0 (Day 1) prior to randomisation
6. Non-childbearing potential female (e.g. permanently sterilised, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening OR
Childbearing potential female subjects or male subjects with their respectively male or
female partners who agree to use at least two forms of appropriate contraception method that
can achieve a failure rate of less than 1% per year e.g. established use of oral, injected,
intravaginal, transdermal or implanted hormonal contraceptive, placement of an intrauterine
device or intrauterine hormone releasing system, bilateral tubal occlusion, vasectomised
partner, physical barrier, sexual abstinence from Screening until 3 months after the last ITV injection of IP
7. Written informed consent form must be obtained from the subject prior to any study related procedure If the subject is legal blindness or illiterate, an impartial witness should be present during the entire informed consent discussion
8. Willingness and ability to undertake all scheduled visits and assessments
 
 
ExclusionCriteria 
Details  1. Sub- or intra-retinal haemorrhage that comprises more than 50 percent of the entire lesion in the study eye, or presence of subfoveal blood equal to or more than one DA in size (confirmed by central reading centre during Screening)
2. Scar, fibrosis or atrophy involving the centre of the fovea in the study eye (confirmed by central reading centre during Screening)
3. 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 (PM) (confirmed by central reading centre during Screening)
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye (confirmed by central reading centre during Screening)
5. Presence of macular hole at any stage in the study eye (confirmed by central reading centre during Screening)
6. Any concurrent macular abnormality other than AMD in the study eye which could affect the efficacy of IP including but not limited to epiretinal membrane, macular telangiectasia, retinal vascular abnormality, etc. (confirmed by central reading centre during Screening)
7. History of vitrectomy surgery in the study eye
8. History of trabeculectomy or other filtration surgery in the study eye
9. History of submacular surgery or other surgical intervention for AMD in the study eye
10. Any other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation
11. Any previous ITV anti-Vascular Endothelial Growth Factor (anti-VEGF) treatment (e.g., bevacizumab, aflibercept, ranibizumab) to treat neovascular AMD in either eye
12. Any previous systemic anti-VEGF treatment, within 90 days prior to randomisation, and such treatment will not be allowed during the study period
13. Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins or mineral will be allowed
14. Any intravitreal injection of corticosteroid (e.g., triamcinolone acetonide) or intravitreal corticosteroid implant in the study eye within 180 days prior to randomisation, and such treatment will not be allowed during the study period
15. Topical ocular corticosteroids administered for ≥ 30 consecutive days in the study eye within 90 days prior to randomization
16. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia. For subjects who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must not exceed 8 diopters of myopia
17. Aphakia or absence of the posterior capsule in the study eye (unless it occurred as a result of a Yttrium Aluminium Garnet [YAG] posterior capsulotomy in association with prior posterior chamber Intraocular Lens [IOL] implantation)
18. Presence of scleromalacia in either eye
19. Current vitreous haemorrhage in the study eye
20. Active or recent (within 28 days prior to randomisation) intraocular, extraocular and periocular inflammation or infection in either eye
21. History of idiopathic or autoimmune uveitis in either eye
22. History of retinal detachment in the study eye
23. History of full-thickness macular hole in the study eye
24. History of corneal transplantation surgery in the study eye
25. Presence of advanced glaucoma or optic neuropathy that affect or threaten the central visual field in the study eye
26. Uncontrolled ocular hypertension (defined as intraocular pressure less than 25 mmHg despite treatment with anti-glaucoma medication) in the study eye
27. History of allergy to the fluorescein sodium for injection in angiography
28. Previous participation in clinical studies of ocular investigational products to treat neovascular AMD in either eye or systemic investigational products to treat neovascular AMD, and such participation will not be allowed during the study period
29. Previous participation in any studies of ocular or systemic investigational products (excluding dietary supplements, vitamins and minerals) to treat ocular or systemic disease other than neovascular AMD within 90 days prior to randomisation, and such participation will not be allowed during the study period even if the investigational product is dietary supplements, vitamins or minerals
30. History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular oedema in either eye
31. Any concurrent ocular condition in the study eye which, in the opinion of the Investigator, could either increase the risk to the subject safety or which otherwise may interfere with evaluation of efficacy or safety including, but not limited to ocular media opacities such as corneal opacity or cataract that do not allow proper fundus visualisation and fundus imaging, and ocular surface abnormalities which prevent applanation tonometry during the study period after randomisation
32. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an IP in the opinion of the Investigator
33. Pregnant or lactating women. A serum pregnancy test must be required for women of childbearing potential at Screening
34. Employees of Investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalised
35. Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to randomisation
36. History of recurrent significant infections and/or current treatment for active systemic infection
37. Known allergic reactions and/or hypersensitivity to ranibizumab or to any ingredients of the investigational product
38. Prior treatment involving macula with photodynamic therapy with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e,g., focal laser photocoagulation) in the study eye, and such treatment will not be allowed during the study period
39. Prior treatment with pan-retinal photocoagulation in the study eye, and such treatment will not be allowed during the study period
40. Current use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin and ethambutol, and such medications will not be allowed during the study period
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To demonstrate the equivalence of efficacy of SB11 to Lucentis® in subjects with neovascular
age-related macular degeneration


2. For US Food and Drug Administration (FDA), Korea Ministry of Food and Drug Safety (MFDS) or other regulatory agency submissions for those who are in favour of VA, the primary endpoint is:

3. For European Medicines Agency (EMA) or other regulatory agency submissions for those who are in favour of anatomical parameter including India, the primary endpoint  		 1. Week 4
2. Change from baseline in BCVA at Week 8
3.Change from baseline in Central Subfield Thickness (CST) at Week 4 (based on assessment by central reading centre)

 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in BCVA over time up to   Week 24 and Week 52 
Proportion of subjects who lost fewer than 15 letters in BCVA compared to baseline at   Week 24 and Week 52 
Proportion of subjects who gained 15 letters or more in BCVA compared to baseline at   Week 24 and Week 52 
Change from baseline in CST and Central Retinal Lesion Thickness (CRLT)   at Week 24 and Week 52 (based on assessment by central reading centre) 
Change from baseline in total CNV size   at Week 24 and Week 52 (based on assessment by central reading centre) 
Proportion of subjects with active CNV leakage   at Week 24 and Week 52 (based on assessment by central reading centre) 
 
Target Sample Size   Total Sample Size="704"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "19"
Final Enrollment numbers achieved (India)="19" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/05/2018 
Date of Study Completion (India) 07/11/2019 
Date of First Enrollment (Global)  23/03/2018 
Date of Study Completion (Global) 05/12/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
 

Phase III study in planned to be conducted in subjects with neovascular age-related macular degeneration (AMD) to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB11 and Lucentis®. This study is randomized, double-blind, parallel-group, multi-centre study.

SB11 or Lucentis® will be administered up to Week 48, and the last assessment will be done at Week 52. Subjects will be randomized in a 1:1 ratio either receive SB11 or Lucentis® (administered via Intravitreal 0.5 mg every 4 weeks).

 



 
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