CTRI/2018/05/013650已完成3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 704
- 试验地点
- 4
- 主要终点
- 1. To demonstrate the equivalence of efficacy of SB11 to Lucentis® in subjects with neovascular
研究概览
简要总结
| 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 50 years at Screening
- •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
- •The area of CNV must occupy at least 50% of total lesion in the study eye confirmed by central reading centre during Screening
- •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
- •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
- •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
- •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
- •Willingness and ability to undertake all scheduled visits and assessments.
排除标准
- •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)
- •Scar, fibrosis or atrophy involving the centre of the fovea in the study eye (confirmed by central reading centre during Screening)
- •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)
- •Presence of retinal pigment epithelial tears or rips involving the macula in the study eye (confirmed by central reading centre during Screening)
- •Presence of macular hole at any stage in the study eye (confirmed by central reading centre during Screening)
- •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)
- •History of vitrectomy surgery in the study eye
- •History of trabeculectomy or other filtration surgery in the study eye
- •History of submacular surgery or other surgical intervention for AMD in the study eye
- •Any previous ITV anti-Vascular Endothelial Growth Factor (anti-VEGF) treatment (e.g., bevacizumab, aflibercept, ranibizumab) to treat neovascular AMD in either eye
- •Any previous systemic anti-VEGF treatment, within 90 days prior to randomisation, and such treatment will not be allowed during the study period
- •However, dietary supplements, vitamins or mineral will be allowed
- •Topical ocular corticosteroids administered for ≥ 30 consecutive days in the study eye within 90 days prior to randomization
- •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
- •Presence of scleromalacia in either eye
- •Active or recent (within 28 days prior to randomisation) intraocular, extraocular and periocular inflammation or infection in either eye
- •History of idiopathic or autoimmune uveitis in either eye
- •History of retinal detachment in the study eye
- •History of full-thickness macular hole in the study eye
- •History of corneal transplantation surgery in the study eye
- •Presence of advanced glaucoma or optic neuropathy that affect or threaten the central visual field in the study eye
- •Uncontrolled ocular hypertension (defined as intraocular pressure less than 25 mmHg despite treatment with anti-glaucoma medication) in the study eye
- •History of allergy to the fluorescein sodium for injection in angiography
- •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
- •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
- •History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular oedema in either eye
- •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
- •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
- •Pregnant or lactating women.
- •A serum pregnancy test must be required for women of childbearing potential at Screening
- •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
- •Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to randomisation
- •History of recurrent significant infections and/or current treatment for active systemic infection
- •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
- •Prior treatment with pan-retinal photocoagulation in the study eye, and such treatment will not be allowed during the study period
- •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.
结局指标
主要结局
1. To demonstrate the equivalence of efficacy of SB11 to Lucentis® in subjects with neovascular
时间窗: 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)
age-related macular degeneration
时间窗: 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)
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:
时间窗: 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)
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
时间窗: 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)
次要结局
- Change from baseline in BCVA over time up to(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))
- 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)
研究者
研究点 (4)
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