NCT02611778已完成3 期
Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bioeq GmbH
- 入组人数
- 712
- 试验地点
- 58
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years of either gender
- •Signed informed consent form must be obtained before any study-related procedure is performed
- •Willingness and ability to undertake all scheduled visits and assessments
- •Women must be postmenopausal or surgically sterile
- •Newly diagnosed, angiographically documented, primary active Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD)
- •Sufficiently clear ocular media and adequate pupillary dilation to permit good quality ocular imaging
- •Best-corrected Visual Acuity (BCVA) in the study eye, determined by standardized Early Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/32 (0.63) and 20/100 (0.2) Snellen equivalent
- •Foveal Center Point (FCP) retinal thickness in at Screening ≥ 350 µm
- •BCVA in the fellow eye, determined by standardized ETDRS testing, at least 20/100 (0.2) Snellen equivalent
排除标准
- •Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized
- •Any previous treatment with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) agent in either eye
- •History of vitrectomy, macular surgery or other surgical intervention for AMD in the study eye
- •History of IVT or periocular injections of corticosteroids or device implantation within six months prior to Screening in the study eye
- •Prior treatment with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e.g. focal laser photocoagulation) in the study eye
- •Topical ocular corticosteroids administered for at least 30 consecutive days within three months prior to Screening
- •Any other intraocular surgery (including cataract surgery) in the study eye within three months prior to Screening
- •Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
- •Fibrosis or atrophy involving the center of the fovea or influencing central visual function in the study eye
- •CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- •Retinal pigment epithelial tear involving the macula in the study eye
- •History of full-thickness macular hole in the study eye
- •History of retinal detachment in the study eye
- •Current vitreous hemorrhage in the study eye
- •Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
- •For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia
- •History of corneal transplant in the study eye
- •Aphakia in the study eye. Absence of an intact posterior capsule is allowed if it occurred as a result of Yttrium-Aluminium-Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation
- •Active or recent (within 4 weeks) intraocular inflammation of clinical significance in the study eye such as active infections of the anterior segment (excluding mild blepharitis) including conjunctivitis, keratitis, scleritis, uveitis or endophthalmitis
- •Uncontrolled hypertension or glaucoma in the study eye (defined as intraocular pressure (IOP) ≥30 mm Hg, despite treatment with anti-glaucomatous medication)
- •Ocular disorders in the study eye (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on visual acuity) at the time of enrollment that may confound interpretation of study results and compromise visual acuity
- •Any concurrent intraocular condition in the study eye (e.g. glaucoma, cataract or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
- •Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half-lives from Screening, whichever is longer
- •Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
- •Stroke or myocardial infarction within three months prior to Screening
- •Presence of uncontrolled systolic blood pressure > 160 mmHg or uncontrolled diastolic blood pressure > 100 mmHg
- •Known hypersensitivity to the investigational drug (ranibizumab or any component of the ranibizumab formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation
- •Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®), tamoxifen, phenothiazines and ethambutol
- •History of recurrent significant infections and/or current treatment for active systemic infection
- •Pregnancy or lactation
- •Systemic treatment with high doses of corticosteroids (administration of >10 mg/day of prednisolone equivalent) during the last six months prior to Screening
- •Inability to comply with study or follow-up procedures
- •Any diagnosis and/or signs of nAMD requiring treatment with an IVT anti-VEGF agent (e.g. aflibercept, bevacizumab, ranibizumab) within the screening period or at study treatment initiation (Visit 1) in the fellow eye
研究组 & 干预措施
Lucentis
Active Comparator
Lucentis® is provided as single use vials and will be administered by intra-vitreal injection.
干预措施: ranibizumab (Biological)
FYB201
Experimental
FYB201 is provided as single use vials and will be administered by intra-vitreal injection.
干预措施: ranibizumab (Biological)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks
时间窗: Baseline and Week 8
The primary endpoint was the absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 2 months (8 weeks) of treatment.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 48 Weeks(Baseline and Week 48)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks(Baseline and Week 24)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 12 Months(Baseline and 12 Months)
- Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 24(Baseline and Week 24)
- Change in NEI VFQ-25 Composite Score From Baseline to Week 24(Baseline and Week 24)
- Fluid-free Macula at Each Visit(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
- Anti-drug Antibodies Pre- and Post-first Dosing(Baseline and up to Week 48)
- Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48(Baseline and Week 48)
- Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 24(Baseline and Week 24)
- Change in Total Lesion Area From Baseline to Week 48(Baseline and Week 48)
- Change in NEI VFQ-25 Composite Score From Baseline to Week 48(Baseline and Week 48)
- Active CNV Leakage at Week 24(Baseline and Week 24)
- Active CNV Leakage at Week 48(Baseline and Week 48)
- Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 48(Baseline and Week 48)
- Change in Total Lesion Area From Baseline to Week 24(Baseline and Week 24)
- Anti-drug Antibodies by Scheduled eCRF Visit(Baseline and Weeks 1, 4, 12, 24, 48)
研究者
研究点 (58)
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