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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 uppdaterad 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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

304

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Läkemedel: Aflibercept (US) 8 mg
IVT injection
Andra namn:
  • EYLEA HD

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Amgen

Utredare

  • Studierektor: MD, Amgen

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 maj 2026

Primärt slutförande (Beräknad)

31 juli 2027

Avslutad studie (Beräknad)

12 januari 2028

Studieregistreringsdatum

Först inskickad

22 maj 2026

Först inskickad som uppfyllde QC-kriterierna

22 maj 2026

Första postat (Faktisk)

29 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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