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Randomisert forsøk som sammenligner umiddelbar vs. utsatt kirurgi for symptomatisk ERM (Protocol AM)

30. oktober 2026 oppdatert av: Jaeb Center for Health Research

Randomisert studie som sammenligner umiddelbar versus utsatt kirurgi for symptomatiske epiretinale membraner

Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259
    • California
      • Glendale, California, Forente stater, 91203-1971
        • Rekruttering
        • Kent W. Small, MD, AMC
        • Ta kontakt med:
      • Huntington Beach, California, Forente stater, 92647-8693
        • Rekruttering
        • Salehi Retina Institute Inc.
        • Ta kontakt med:
      • Loma Linda, California, Forente stater, 92354
        • Rekruttering
        • Loma Linda University
        • Ta kontakt med:
      • Mountain View, California, Forente stater, 94040-4123
        • Rekruttering
        • Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
        • Ta kontakt med:
      • Oakland, California, Forente stater, 94609-3028
        • Rekruttering
        • East Bay Retina Consultants, Inc.
        • Ta kontakt med:
      • Sacramento, California, Forente stater, 95817
        • Rekruttering
        • Regents of the University of California, Davis, DBA University of California, Davis
        • Ta kontakt med:
      • Torrance, California, Forente stater, 90503
        • Rekruttering
        • Macula Retina Vitreous Institute
        • Ta kontakt med:
    • Florida
      • Jacksonville, Florida, Forente stater, 32216
        • Rekruttering
        • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
        • Ta kontakt med:
      • Sarasota, Florida, Forente stater, 34239
        • Rekruttering
        • Sarasota Retina Institute
        • Ta kontakt med:
      • Wesley Chapel, Florida, Forente stater, 33544
        • Rekruttering
        • SEASHORE RETINA LLC DBA Retina Specialists of Tampa
        • Ta kontakt med:
    • Georgia
      • 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:
      • Chicago, Illinois, Forente stater, 60611
      • Chicago, Illinois, Forente stater, 60612
        • Rekruttering
        • UIC - Department of Ophthalmology and Visual Sciences
        • Ta kontakt med:
          • Jennifer I Lim, MD
          • Telefonnummer: 312-355-3743
          • E-post: jiashe@uic.edu
      • Oak Park, Illinois, Forente stater, 60304
        • Rekruttering
        • Illinois Retina Associates SC - Oak Park Site
        • Ta kontakt med:
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46290
        • Rekruttering
        • Raj K. Maturi, M.D., P.C.
        • Ta kontakt med:
    • Kansas
      • Overland Park, Kansas, Forente stater, 66211
        • Rekruttering
        • Mid-America Retina Consultants, P.A.
        • Ta kontakt med:
      • Prairie Village, Kansas, Forente stater, 66208
        • Rekruttering
        • University of Kansas Medical Center Research Institute, Inc.
        • 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, 21287
        • Rekruttering
        • Johns Hopkins University
        • Ta kontakt med:
          • Sharon D. Solomon, MD
          • Telefonnummer: 410-614-6908
          • E-post: mfrey3@jhmi.edu
      • Baltimore, Maryland, Forente stater, 21237
        • Rekruttering
        • Elman Retina Group, P.A.
        • Ta kontakt med:
    • Massachusetts
      • Ayer, Massachusetts, Forente stater, 01432
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Joslin Diabetes Center
        • Ta kontakt med:
    • Michigan
      • Grand Blanc, Michigan, Forente stater, 48439
        • Rekruttering
        • Retina Associates of Michigan
        • Ta kontakt med:
    • Missouri
      • Columbia, Missouri, Forente stater, 65201-5276
      • St Louis, Missouri, Forente stater, 63128-1729
        • Rekruttering
        • Retina Research Institute, LLC
        • Ta kontakt med:
    • New York
      • Liverpool, New York, Forente stater, 13088
        • Rekruttering
        • Retina-Vitreous Surgeons of Central NY, PC
        • Ta kontakt med:
      • Rochester, New York, Forente stater, 14620-4655
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27517
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Ta kontakt med:
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73013-9791
        • Rekruttering
        • Retina Vitreous Center
        • Ta kontakt med:
    • Oregon
      • Eugene, Oregon, Forente stater, 97401
        • Rekruttering
        • Verum Research LLC
        • Ta kontakt med:
      • Springfield, Oregon, Forente stater, 97477
    • Pennsylvania
      • Monroeville, Pennsylvania, Forente stater, 15146
      • Philadelphia, Pennsylvania, Forente stater, 19104
      • Sewickley, Pennsylvania, Forente stater, 15143
        • Rekruttering
        • Pittsburg Clinical Trial Consortium
        • Ta kontakt med:
    • South Carolina
      • Hilton Head Island, South Carolina, Forente stater, 29926
        • Rekruttering
        • Hilton Head Retina Institute
        • Ta kontakt med:
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57108
        • Rekruttering
        • Ophthalmology Ltd.
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Rekruttering
        • Vanderbilt Eye Institute
        • Ta kontakt med:
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Rekruttering
        • Austin Research Center for Retina
        • Ta kontakt med:
      • Bellaire, Texas, Forente stater, 77401
      • Houston, Texas, Forente stater, 77030
        • 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:
      • San Antonio, Texas, Forente stater, 78240
        • Rekruttering
        • Retinal Consultants of San Antonio
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • The University of Texas Health Science Center at San Antonio
        • Ta kontakt med:
    • Virginia
      • Reston, Virginia, Forente stater, 20190
        • Rekruttering
        • The Retina Group of Washington
        • Ta kontakt med:
    • Washington
      • Spokane, Washington, Forente stater, 99204
        • Rekruttering
        • Spokane Eye Clinical Research, PLLC
        • Ta kontakt med:
  • Storbritannia
    • Tyne and Wear
      • Sunderland, Tyne and Wear, Storbritannia, SR29HP
        • Rekruttering
        • South Tyneside and Sunderland NHS Trust
        • 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

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

  • Age ≥ 45 years

  • E-ETDRS visual acuity 20/40 or better (≥69 letters)

    o ERM must be thought to be the primary cause of vision loss

  • ERM meeting the following criteria, according to the investigator

    • ERM is not secondary to another condition
    • Symptoms of visual loss and/or distortion (in the opinion of the investigator, the ERM is contributing to the participant's symptoms); either new or worsening in the past 24 months
    • Epiretinal membrane involving or altering the central 3 mm of the macula on OCT
    • Distortion within the central subfield due to ERM on OCT

  • Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 weeks to see if vision remains stable without having to proceed to vitrectomy)

  • No known medical problems that will be a contraindication to surgery

Key Exclusion Criteria:

  • History of retinal vascular disease

  • History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM

    o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion

  • History of inflammatory disease unless mild and completely resolved at least one year prior to randomization

  • History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved >1 year prior to randomization)

  • Prior intraocular surgery (except uncomplicated cataract extraction)

  • Cataract extraction within prior 3 months

  • Laser or cryosurgical retinopexy within one month of randomization

  • Pneumatic retinopexy within one year of randomization

  • Current untreated retinal tear or detachment

    o A previously treated retinal tear with up to one disc diameter radius of subretinal fluid is permitted

  • Macular hole

  • Degenerative lamellar macular hole

    o ERM foveoschisis ("tractional" lamellar hole) is permitted

  • Vitreomacular traction within 1,500 microns of foveal center

  • Central serous chorioretinopathy

  • Nonproliferative diabetic retinopathy or worse (DR severity >20)

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: Umiddelbar Vitrektomi
Fremgangsmåte: Immediate Vitrectomy

Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Annen: Utsatt Vitrektomi
Fremgangsmåte: Deferred Vitrectomy

Vitrectomy may be performed only if at least one of the following criteria is met:

  1. Decrease in visual acuity ≥10 letters from baseline at a single visit presumed to be from ERM

  2. Decrease in visual acuity ≥5 letters from baseline at two consecutive visits presumed to be from ERM

    a. Visits must be at least one month apart

  3. Participant actively requests surgery due to worsening symptoms

  4. Complication requires prompt surgical intervention (e.g., macular hole, retinal detachment, non-clearing vitreous hemorrhage)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean change in visual acuity letter score from baseline to 36 months
Tidsramme: Baseline to 36 months

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, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Baseline to 36 months

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

Juvenile Diabetes Research Foundation
National Eye Institute (NEI)
National Institutes of Health (NIH)

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)

22. februar 2022

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

1. desember 2021

Først innsendt som oppfylte QC-kriteriene

1. desember 2021

Først lagt ut (Faktiske)

6. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DRCR.net Protocol AM
  • UG1EY014231 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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. .

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