CTRI/2023/03/050806进行中（未招募）3 期
A Phase III, Prospective, Randomized, Parallel group, Double-blind, Multicentre Study to Compare the Efficacy, Safety, and Immunogenicity of Lupin’s Aflibercept with Eylea® in Patients with Neovascular Age-Related Macular Degeneration
Ms Lupin Limited32 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2023年3月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 498
- 试验地点
- 32
- 主要终点
- Mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 48.
研究概览
简要总结
THIS IS A PHASE III, PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, MULTICENTRE STUDY TO COMPARE THE EFFICACY, SAFETY, AND IMMUNOGENICITY OF LUPIN’S AFLIBERCEPT WITH EYLEA® IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ambulatory male or female participants with age ≥50 years who are capable of understanding and giving written informed consent.
- •2.Active sub-foveal choroidal neovascularization (CNV) lesion secondary to AMD in the study eye.
- •Active CNV is defined as any leakage detected on fluorescein angiography (FA).
- •3.BCVA between 20/40 and 20/200 (Snellen equivalent), both inclusive, in the study eye before pupil dilation, using Early treatment diabetic retinopathy study (ETDRS) testing.
- •4.Females, who are of non-childbearing potential (surgically sterile or menopausal), OR, if of childbearing potential using effective birth control measures during the study and 3 months after the last dose and who are non-pregnant and non-lactating at study entry.
- •5.Willing and able to undertake all scheduled visits and assessments.
排除标准
- •1.Sub-retinal hemorrhage that comprises >50% of the total lesion or presence of blood with the size of 1 DA (disc areas) or more involving the center of fovea in the study eye as assessed by FA.
- •2.Scar or fibrosis, making up >50% of total lesion in the study eye as assessed by FA.
- •3.Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA.
- •4.Total lesion area ≥12.0 DA in size (including blood, scars, and neovascularization) as assessed by FA in the study eye.
- •5.Presence of CNV due to other causes, such as pathologic myopia (spherical equivalent of -8.0 diopters or more, or axial length of 25 mm or more), trauma, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
- •6.Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- •7.Presence of macular hole of any stage in the study eye.
- •8.Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy assessments in the study eye.
- •9.Any concurrent ocular/intraocular condition in the study eye which, in the opinion of the Investigator, may interfere with the injection procedure or may confound the evaluation of efficacy or safety.
- •10.History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or any other vascular disease affecting the retina, other than AMD, in either eye.
- •13.Any prior ocular treatment/surgery for neovascular AMD in the study eye within 12 months prior to randomization.
- •14.Prior treatment with aflibercept in the fellow eye.
- •15.History of previous systemic treatment with Aflibercept or requiring concurrent systemic anti-VEGF treatment during study.
- •16.History of vitrectomy, scleral buckling (encircling), glaucoma filtration surgery, or pan-retinal photocoagulation in the study eye.
- •17.Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization.
- •18.Previous treatment with intravitreal steroid implant in the study eye (like Ozurdex®) or with long-acting systemic steroid within 6 months prior to randomization.
- •19.Any intraocular or periocular surgery within 3 months prior to randomization in the study eye.
- •20.Previous radiation therapy in the region of the study eye.
- •21.Previous participation in any clinical study for treatment of neovascular AMD in study eye or previous participation in any clinical study for treatment of neovascular AMD in fellow eye within last 3 months prior to randomization.
- •22.Concurrent treatment with an investigational drug or device in the study eye or non-study eye for treatment of disease other than neovascular AMD, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational drug or device study(ies) prior to randomization.
- •23."Aphakia or pseudophakia with absence of the posterior capsule [unless it occurred as a result of a yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation] in the study eye.
- •24.Active intraocular inflammation including scleritis or active or suspected ocular or periocular infection in either eye, within 2 weeks prior to randomization.
- •25.Clinical evidence of uveitis in either eye.
- •26.Uncontrolled glaucoma (defined as intraocular pressure [IOP] ≥ 25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
- •28.Known hypersensitivity to aflibercept or any of the components of study medication.
- •29.History of allergy to the fluorescein sodium for injection in angiography.
- •30.History or presence of concurrent systemic diseases or dysfunctions requiring significant medical/surgical intervention during study period that might affect interpretation of the results or contraindicates the use of aflibercept or render the subject at high risk for treatment complications based on the Investigator’s judgment such as Cardiovascular disease (e.g., stroke, myocardial infarction), uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g., optic neuropathy), metabolic, pulmonary, autoimmune disease or psychiatric disease based on previous history and relevant reports of clinical examination, laboratory tests, or electrocardiogram (ECG) etc.
结局指标
主要结局
Mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 48.
时间窗: From baseline to Week 48.
次要结局
- Efficacy Endpoint: Mean change in BCVA from baseline to Week 16 and Week 32.(From baseline to Week 16 and Week 32.)
- Safety Endpoint: Incidence of treatment emergent adverse events (TEAEs).
- Immunogenicity Endpoint: Proportion of patients with anti-drug antibodies at pre-dose (Day 1), 4, 8, 16, 32, and 48 weeks.(At pre-dose (Day 1), 4, 8, 16, 32, and 48 weeks.)
研究者
研究点 (32)
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