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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

16. september 2026 oppdatert av: 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)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

304

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: ABP 938 8 mg
IVT injection
Aktiv komparator: 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.
Legemiddel: Aflibercept (US) 8 mg
IVT injection
Andre navn:
  • EYLEA HD

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amgen

Etterforskere

  • Studieleder: MD, Amgen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. mai 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

12. januar 2028

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20250115
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523500-72-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere