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Faricimab + PRP vs. vitrektomi + endolaser for behandling av PDR (AP)

15. september 2026 oppdatert av: Jaeb Center for Health Research

En randomisert klinisk studie som evaluerer kombinasjonen Faricimab + PRP vs. vitrektomi + endolaser for behandling av proliferativ diabetisk retinopati

This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Although some combination of anti-VEGF plus PRP is the most common treatment approach for PDR with and without DME, there are currently no long-term data on a standardized approach. Vitrectomy is not currently used as first-line treatment for early PDR but advances in surgical technique have reduced associated complications and the ability to remove the posterior hyaloid during surgery may have advantages over nonsurgical approaches, especially in the reduction of vitreous hemorrhage and/or traction retinal detachment that may occur later when the hyaloid separates naturally. Protocol S demonstrated both PRP and anti-VEGF alone result in good visual acuity results long-term so it is expected that a combination treatment would also result in good visual acuity results.

This study will evaluate the safety and efficacy of two treatment strategies for PDR: faricimab plus PRP and Vitrectomy with endolaser with the goal to determine whether either approach decreases visit and treatment burden along with decreasing complications compared with the other treatment method while maintaining good visual acuity. The primary objectives of this study are to compare visual acuity at 3 years following vitrectomy with endolaser or faricimab+PRP and to compare number of treatments for PDR (i.e., injections, PRP, vitrectomy) following the end of randomized treatment over 3 years.

Studietype

Intervensjonell

Registrering (Antatt)

426

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
      • Huntington Beach, California, Forente stater, 92647
        • Rekruttering
        • Retina Associates of Southern California
        • Ta kontakt med:
      • Loma Linda, California, Forente stater, 92354
        • Rekruttering
        • Loma Linda University
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94109
        • Rekruttering
        • West Coast Retina Medical Group, Inc.
        • Ta kontakt med:
      • Santa Barbara, California, Forente stater, 93103-4223
        • Rekruttering
        • California Retina Consultants
        • Ta kontakt med:
    • Florida
      • Jacksonville, Florida, Forente stater, 32209
        • Rekruttering
        • University of Florida - Jacksonville
        • Ta kontakt med:
      • Lakeland, Florida, Forente stater, 33805
        • Rekruttering
        • Florida Retina Consultants
        • Ta kontakt med:
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Ophthalmic Partners of Florida, PA dba Central Florida Retina
        • Ta kontakt med:
      • Tampa, Florida, Forente stater, 33609
        • Rekruttering
        • Retina Associates of Florida, LLC
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Rekruttering
        • Emory Eye Center
        • Ta kontakt med:
          • Andrew M Hendrick, MD
          • Telefonnummer: 404-778-4261
          • E-post: mafif@emory.edu
      • Augusta, Georgia, Forente stater, 30909
        • Rekruttering
        • Southeast Retina Center, P.C.
        • Ta kontakt med:
      • Sandy Springs, Georgia, Forente stater, 30328
        • Rekruttering
        • Thomas Eye Group
        • Ta kontakt med:
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rekruttering
        • Rush University Medical Center
        • Ta kontakt med:
      • Oak Park, Illinois, Forente stater, 60304
        • Rekruttering
        • Illinois Retina Associates SC Oak Park Site
        • Ta kontakt med:
    • Indiana
      • Carmel, Indiana, Forente stater, 46032
        • Rekruttering
        • Midwest Eye Institute
        • Ta kontakt med:
      • Indianapolis, Indiana, Forente stater, 46202
        • Rekruttering
        • The Trustees of Indiana University
        • Ta kontakt med:
          • Amir R. Hajrasouliha, MD
          • Telefonnummer: 317-944-2020
          • E-post: skarra@iu.edu
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50266
        • Rekruttering
        • Wolfe Clinic, P.C.- West Des Moines
        • Ta kontakt med:
    • Kansas
      • Overland, Kansas, Forente stater, 66211
        • Rekruttering
        • Mid-America Retina Consultants, P.A.
        • Ta kontakt med:
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40508
        • Rekruttering
        • University of Kentucky Advanced Eye Care
        • Ta kontakt med:
    • Louisiana
      • West Monroe, Louisiana, Forente stater, 71291-4452
        • Rekruttering
        • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237
        • Rekruttering
        • Elman Retina Group, P.A.
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Joslin Diabetes Center
        • Ta kontakt med:
      • Boston, Massachusetts, Forente stater, 02118
        • Rekruttering
        • Boston Medical Center Corporation
        • Ta kontakt med:
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Rekruttering
        • Mayo Clinic
        • Ta kontakt med:
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Rekruttering
        • Retina Consultants of Minnesota
        • Ta kontakt med:
    • Missouri
      • St Louis, Missouri, Forente stater, 63128
        • Rekruttering
        • Retina Research Institute, LLC
        • Ta kontakt med:
    • New York
      • Rochester, New York, Forente stater, 14620
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27517-8923
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Ta kontakt med:
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73013
        • Rekruttering
        • Retina Vitreous Center
        • Ta kontakt med:
    • Pennsylvania
      • Monroeville, Pennsylvania, Forente stater, 15146
        • Rekruttering
        • Retina-Vitreous Consultants, Inc.
        • Ta kontakt med:
    • Texas
      • Austin, Texas, Forente stater, 78705
      • Bellaire, Texas, Forente stater, 77401
      • Dallas, Texas, Forente stater, 75390
      • Houston, Texas, Forente stater, 77030-4101
        • Rekruttering
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • Ta kontakt med:
      • Lubbock, Texas, Forente stater, 79424
        • Rekruttering
        • Texas Retina Associates
        • Ta kontakt med:

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Individual:

  • ≥ 18 years old
  • Diagnosis of diabetes mellitus (type 1 or type 2)

Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)

  • Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center
  • Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)

Exclusion Criteria:

  • Individual:

    • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.

    • Blood pressure > 160/100 (systolic above 160 or diastolic above 100).

      o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible.

    • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.

      • Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up.

Study Eye: (A participant can have two study eyes.)

  • Traction retinal detachment involving the macula
  • Significant vitreous hemorrhage that would preclude completion of a full PRP
  • Significant vitreomacular traction
  • Any prior vitrectomy
  • Any prior PRP (defined as ≥100 burns outside of the posterior pole)
  • Treatment for DME within the prior 6 months
  • Intravitreal anti-VEGF for any indication, other than DME, within the prior year

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Vitrektomi + endolaser
Fremgangsmåte: Vitrectomy

The vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted.

Enhet: Endolaser

Complete panretinal photocoagulation (PRP) during vitrectomy
Eksperimentell: Faricimab + PRP

PRP = Panretinal Photocoagulation
Legemiddel: Faricimab

Treatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization.

Enhet: Panretinal Photocoagulation (PRP)

Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Acuity Change from Baseline
Tidsramme: Baseline to 3- years

Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40.
Baseline to 3- years
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Tidsramme: Over 3 Years

Initial randomized treatment will be excluded.
Over 3 Years

Samarbeidspartnere og etterforskere

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

Sponsor

Jaeb Center for Health Research

Samarbeidspartnere

National Eye Institute (NEI)
Genentech, Inc.

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)

4. august 2025

Primær fullføring (Antatt)

1. august 2031

Studiet fullført (Antatt)

1. august 2031

Datoer for studieregistrering

Først innsendt

10. januar 2025

Først innsendt som oppfylte QC-kriteriene

23. januar 2025

Først lagt ut (Faktiske)

24. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Protocol AP
  • UG1EY014231 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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. .

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