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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 bijgewerkt door: 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)

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

304

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: ABP 938 8 mg
IVT injection
Actieve vergelijker: 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.
Geneesmiddel: Aflibercept (US) 8 mg
IVT injection
Andere namen:
  • EYLEA HD

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Onderzoekers

  • Studie directeur: MD, Amgen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 mei 2026

Primaire voltooiing (Geschat)

31 juli 2027

Studie voltooiing (Geschat)

12 januari 2028

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20250115
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523500-72-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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