이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 16일 업데이트: 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)

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

304

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: ABP 938 8 mg
IVT injection
활성 비교기: 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.
의약품: Aflibercept (US) 8 mg
IVT injection
다른 이름들:
  • EYLEA HD

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
기간: Baseline and Week 12
Baseline and Week 12

2차 결과 측정

결과 측정
기간
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)
기간: Week 16
Week 16
Change from Baseline in BCVA as measured by ETDRS letter score
기간: Baseline to Week 48
Baseline to Week 48
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24
기간: Baseline to Week 24
Baseline to Week 24
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48
기간: Baseline to Week 48
Baseline to Week 48
Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)
기간: Baseline to Week 48
Baseline to Week 48
Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT
기간: 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
기간: 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
기간: Week 48
Week 48
Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
기간: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Non-Ocular TEAEs
기간: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)
기간: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)
기간: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)
기간: Baseline up to Week 48
Baseline up to Week 48
Free serum concentrations of ABP 938 8 mg
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Amgen

수사관

  • 연구 책임자: MD, Amgen

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 27일

기본 완료 (추정된)

2027년 7월 31일

연구 완료 (추정된)

2028년 1월 12일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 5월 22일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 16일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20250115
  • 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523500-72-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다