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Faricimab + PRP vs. vitrektomi + endolaser til behandling af PDR (AP)

15. september 2026 opdateret af: Jaeb Center for Health Research

Et randomiseret klinisk forsøg, der evaluerer kombinationen Faricimab + PRP vs. Vitrektomi + Endolaser til behandling af 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

426

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Vitrektomi + endolaser
Procedure: 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.

Enhed: Endolaser

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

PRP = Panretinal Photocoagulation
Medicin: 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.

Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jaeb Center for Health Research

Samarbejdspartnere

National Eye Institute (NEI)
Genentech, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. august 2025

Primær færdiggørelse (Anslået)

1. august 2031

Studieafslutning (Anslået)

1. august 2031

Datoer for studieregistrering

Først indsendt

10. januar 2025

Først indsendt, der opfyldte QC-kriterier

23. januar 2025

Først opslået (Faktiske)

24. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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