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A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

2026年9月16日 更新者：Amgen

A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration

The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

304

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 拉脱维亚
    • Riga
      • Riga、Riga、拉脱维亚、LV-1009
        • 招聘中
        • Latvian American Eye Center
  • 捷克语
    • Hradec Králové Region
      • Náchod、Hradec Králové Region、捷克语、547 01
        • 招聘中
        • Visus, spol. s r.o. - Nachod
    • Prague
      • Prague、Prague、捷克语、150 00
        • 招聘中
        • AXON clinical
    • Stredoceský Kraj
      • Mladá Boleslav、Stredoceský Kraj、捷克语、293 01
        • 招聘中
        • Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje - Klaudianova nemocnice
  • 斯洛伐克
    • Košice Region
      • Trebišov、Košice Region、斯洛伐克、075 01
        • 招聘中
        • NsP Trebisov, a.s. - Ocne oddelenie
    • Trenčín Region
      • Trenčín、Trenčín Region、斯洛伐克、911 71
        • 招聘中
        • Fakultna nemocnica Trencin - Ocna klinika
    • Žilina Region
      • Žilina、Žilina Region、斯洛伐克、012 07
        • 招聘中
        • Fakultna nemocnica s poliklinikou Zilina - Ocne oddelenie
  • 日本
    • Tokyo
      • Meguro-ku、Tokyo、日本、152-8902
        • 招聘中
        • Tokyo Medical Center - Ophthalmology
  • 波兰
    • Masovian Voivodeship
      • Kraków、Masovian Voivodeship、波兰、30-363
        • 招聘中
        • Szpital sw. Rozy Sp. z o.o.
    • Warmian-Masurian Voivodeship
      • Olsztyn、Warmian-Masurian Voivodeship、波兰、10-424
        • 招聘中
        • Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
  • 美国
    • California
      • Fullerton、California、美国、92835-3432
        • 招聘中
        • Retina Consultants of Orange County
      • Long Beach、California、美国、90607
        • 招聘中
        • South Coast Retina Center - RCA
      • Modesto、California、美国、95356
        • 招聘中
        • Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)
      • Pasadena、California、美国、91107
        • 招聘中
        • California Eye Specialists Medical Group, Inc
      • Sacramento、California、美国、95825
        • 招聘中
        • Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
      • Santa Barbara、California、美国、93103
        • 招聘中
        • California Retina Consultants
    • Colorado
      • Colorado Springs、Colorado、美国、80909-1183
        • 招聘中
        • Retina Consultants of Southern Colorado (Colorado Springs)- RCA
      • Colorado Springs、Colorado、美国、80909
        • 招聘中
        • Retina Consultants of Southern Colorado (Pueblo)- RCA
      • Lakewood、Colorado、美国、80228
        • 招聘中
        • Colorado Retina Associates (RCA)
    • Connecticut
      • Waterford、Connecticut、美国、06385
        • 招聘中
        • Retina Group of New England
    • Florida
      • Miami、Florida、美国、33143
        • 招聘中
        • Medeye Associates - Research
      • Naples、Florida、美国、34103-4457
        • 招聘中
        • Retina Consultants of Southwest Florida - Naples
      • Pensacola、Florida、美国、32503
        • 招聘中
        • Advanced Research, LLC
    • Illinois
      • Elmhurst、Illinois、美国、60126
        • 招聘中
        • Retina Associates
      • Oak Forest、Illinois、美国、60452
        • 招聘中
        • University Retina - Bedford Park Location
    • Indiana
      • Carmel、Indiana、美国、46032
        • 招聘中
        • Associated Vitreoretinal and Uveitis Consultants
    • Maryland
      • Baltimore、Maryland、美国、21209
        • 招聘中
        • The Retina Care Center- Baltimore (PRISM Vision Group)
      • Hagerstown、Maryland、美国、21740-5846
        • 招聘中
        • Mid Atlantic Retina Specialists
      • Towson、Maryland、美国、21204
        • 招聘中
        • Retina Specialists
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Ophthalmic Consultants of Boston
    • Minnesota
      • Edina、Minnesota、美国、55435
        • 招聘中
        • Retina Consultants of Minnesota
    • Mississippi
      • Madison、Mississippi、美国、39110
        • 招聘中
        • Mississippi Retina Assoc
    • Missouri
      • St Louis、Missouri、美国、63128
        • 招聘中
        • The Retina Institute, Research Retina Institute (RCA)
    • New Jersey
      • Bloomfield、New Jersey、美国、07003
        • 招聘中
        • Envision Ocular, LLC
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • 招聘中
        • Vision Research Center Eye Associates of New Mexico
    • New York
      • Liverpool、New York、美国、13088
        • 招聘中
        • Retina Vitreous Surgeons of CNY, PC
      • Oceanside、New York、美国、11572
        • 招聘中
        • Ophthalmic Consultants of Long Island - Research
    • North Carolina
      • Raleigh、North Carolina、美国、27607-7514
        • 招聘中
        • North Carolina Retina Associates
      • Wake Forest、North Carolina、美国、27587
        • 招聘中
        • NC Retina Associates-RCA
    • Ohio
      • Dublin、Ohio、美国、43016
        • 招聘中
        • Midwest Retina - Main Office
    • Pennsylvania
      • Kingston、Pennsylvania、美国、18704-4801
        • 招聘中
        • Eye Care Specialists - Kingston
    • South Carolina
      • Beaufort、South Carolina、美国、29902
        • 招聘中
        • Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)
      • Charleston、South Carolina、美国、29414-5896
        • 招聘中
        • Charleston Neuroscience Institute
      • Columbia、South Carolina、美国、29169
        • 招聘中
        • Palmetto Retina Center - Main (RCA)
      • Ladson、South Carolina、美国、29456
        • 招聘中
        • Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
      • Mt. Pleasant、South Carolina、美国、29464
        • 招聘中
        • Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA)
      • West Columbia、South Carolina、美国、29169
        • 招聘中
        • Palmetto Retina Center, Florence (RCA)
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Tennessee Retina PC
    • Texas
      • Arlington、Texas、美国、76012
        • 招聘中
        • Texas Retina Associates (TRA) - Arlington
      • Austin、Texas、美国、78705
        • 招聘中
        • Austin Retina Associates
      • Austin、Texas、美国、78705
        • 招聘中
        • Austin Retina Associates - Ophthalmology/Retina
      • Bellaire、Texas、美国、77401
        • 招聘中
        • Retina Consultants of Texas - Bellaire
      • Dallas、Texas、美国、75231
        • 招聘中
        • Texas Retina Associates (TRA) - Dallas Main
      • Fort Worth、Texas、美国、76104
        • 招聘中
        • Texas Retina Associates - Fort Worth
      • Houston、Texas、美国、77401
        • 招聘中
        • Retina Consultants of Texas - Katy Retina Center
      • Katy、Texas、美国、77494
        • 招聘中
        • Retina Consultants of Texas - The Woodlands
      • San Antonio、Texas、美国、78240
        • 招聘中
        • Retinal Consultants of Texas- San Antonio
      • Schertz、Texas、美国、78154
        • 招聘中
        • Retina Consultants of Texas - Schertz
      • Willow Park、Texas、美国、76087
        • 招聘中
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City、Utah、美国、84107
        • 招聘中
        • Retina Associates of Utah - Retina Specialist
    • Virginia
      • Falls Church、Virginia、美国、22042-2349
        • 招聘中
        • Emerson Clinical Research- Virginia Retina Specialists
    • Washington
      • Bellevue、Washington、美国、98004-3779
        • 招聘中
        • Vitreoretinal Associates of Washington
      • Silverdale、Washington、美国、98383
        • 招聘中
        • Retina Center NW PLLC
      • Spokane、Washington、美国、99204-2509
        • 招聘中
        • Spokane Eye Clinic (OCT and optical exam

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Men or women ≥ 50 years old, capable of giving signed informed consent
  • Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
  • Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE
  • The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
  • Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:

  • Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
  • Scar, fibrosis, or atrophy involving the central subfield in the study eye
  • Scar or fibrosis involving > 50% of the total lesion in the study eye
  • Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
  • History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study
  • Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study
  • Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye
  • History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye
  • Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization
  • Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening
  • Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins
  • History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation
  • Other protocol-specified exclusion criteria

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：ABP 938 8 mg
Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
药品：ABP 938 8 mg
IVT injection
有源比较器：Aflibercept (US) 8 mg
Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
药品：Aflibercept (US) 8 mg
IVT injection
其他名称：
  • EYLEA HD

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
大体时间：Baseline and Week 12
Baseline and Week 12

次要结果测量

结果测量
大体时间
Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield, as Assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT)
大体时间：Week 16
Week 16
Change from Baseline in BCVA as measured by ETDRS letter score
大体时间：Baseline to Week 48
Baseline to Week 48
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24
大体时间：Baseline to Week 24
Baseline to Week 24
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48
大体时间：Baseline to Week 48
Baseline to Week 48
Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)
大体时间：Baseline to Week 48
Baseline to Week 48
Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT
大体时间：Baseline to Week 48
Baseline to Week 48
Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments
大体时间：Week 16 and Week 20
Week 16 and Week 20
Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments
大体时间：Week 48
Week 48
Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
大体时间：Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Non-Ocular TEAEs
大体时间：Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)
大体时间：Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)
大体时间：Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)
大体时间：Baseline up to Week 48
Baseline up to Week 48
Free serum concentrations of ABP 938 8 mg
大体时间：Week 16, week 24 and 48 (End of Study)
Week 16, week 24 and 48 (End of Study)
Free serum concentrations of Aflibercept (US) 8 mg
大体时间：Week 16, week 24, and 48 (End of Study)
Week 16, week 24, and 48 (End of Study)
Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy
大体时间：From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy
大体时间：From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
From Baseline (day 1, week 0) to Day 29 (pre dose week 4)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amgen

调查人员

  • 研究主任：MD、Amgen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月27日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2028年1月12日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20250115
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523500-72-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD 共享时间框架

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD 共享访问标准

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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