Neovascular Age-related Macular Degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: SB11 (proposed ranibizumab biosimilar)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: SB11
Concentration unit:
Sponsors
Samsung Bioepis Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age = 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 = 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 352 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 352
Exclusion criteria
Exclusion criteria: 1.Sub- or intra-retinal haemorrhage that comprises more than 50% 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 as assessed by FA (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 randomisation 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 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 transplantion surgery in the study eye 25.Presence of advanced glaucoma or optic neuropathy that affect or threaten the central visual
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline and week 4;Main Objective: To demonstrate the equivalence of efficacy of SB11 to Lucentis® in subjects with neovascular age-related macular degeneration;Secondary Objective: •To evaluate the safety of SB11 and Lucentis® •To evaluate the immunogenicity of SB11 and Lucentis® •To evaluate the systemic exposure of SB11 and Lucentis® in subjects participating in pharmacokinetics (PK) evaluation ;Primary end point(s): For European Medicines Agency (EMA) or other regulatory agency submissions for those who are in favour of the anatomical parameter, the primary endpoint is: •Change from baseline in Central Subfield Thickness (CST) at Week 4 (based on assessment by central reading centre) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •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) ;Timepoint(s) of evaluation of this end point: Baseline, week 24, week 52 | — |
Countries
Czech Republic, Germany, Hungary, India, Korea, Republic of, Poland, Russian Federation, United Kingdom, United States
Contacts
Public ContactInformation Desk
Samsung Bioepis Co., Ltd.
Outcome results
None listed