NCT04522167已完成3 期
A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bioeq GmbH
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.
研究概览
简要总结
This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® 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 at Screening.
- •Male or female:
- •Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment.
- •Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP), OR
- •A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Willingness and ability to undertake all scheduled visits and assessments.
- •Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD
排除标准
- •Patients are not eligible for the study if any of the following criteria apply:
- •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.
- •Study eye requiring immediate treatment.
- •Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
- •Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).
- •Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
- •Any concurrent intraocular condition in the SE (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 randomization, 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 6 months prior to randomization.
- •Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.
研究组 & 干预措施
FYB203 (Proposed aflibercept biosimilar)
Experimental
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
干预措施: FYB203 (Proposed aflibercept biosimilar) (Drug)
Eylea® (Aflibercept)
Active Comparator
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
干预措施: Eylea® (Aflibercept) (Drug)
结局指标
主要结局
Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.
时间窗: Week 8
Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.
次要结局
- Evaluate and Compare Functional Changes of the Retina by BCVA Over Time(Through study completion, until Week 56 (Visit 9))
- Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness(Through study completion, until Week 56 (Visit 9))
- Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline(Through study completion, until Week 56 (Week 9))
- Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time(Through study completion, until Week 56 (Visit 9))
- Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)(At Baseline and Visit 3a (48 hours after the 3rd dose))
- Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)(Through study completion, until Week 56 (Visit 9))
- Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum(Through study completion, until Week 56 (Visit 9))
- Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)(Through study completion, until Week 56 (Visit 9))
研究者
研究点 (1)
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