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Randomiseret forsøg, der sammenligner øjeblikkelig vs. udskudt kirurgi for symptomatisk ERM (Protocol AM)

30. oktober 2026 opdateret af: Jaeb Center for Health Research

Randomiseret forsøg, der sammenligner øjeblikkelig versus udskudt 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
    • Tyne and Wear
      • Sunderland, Tyne and Wear, Det Forenede Kongerige, SR29HP
        • Rekruttering
        • South Tyneside and Sunderland NHS Trust
        • Kontakt:
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
    • California
      • Glendale, California, Forenede Stater, 91203-1971
        • Rekruttering
        • Kent W. Small, MD, AMC
        • Kontakt:
      • Huntington Beach, California, Forenede Stater, 92647-8693
      • Loma Linda, California, Forenede Stater, 92354
        • Rekruttering
        • Loma Linda University
        • Kontakt:
      • Mountain View, California, Forenede Stater, 94040-4123
        • Rekruttering
        • Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
        • Kontakt:
      • Oakland, California, Forenede Stater, 94609-3028
        • Rekruttering
        • East Bay Retina Consultants, Inc.
        • Kontakt:
      • Sacramento, California, Forenede Stater, 95817
        • Rekruttering
        • Regents of the University of California, Davis, DBA University of California, Davis
        • Kontakt:
      • Torrance, California, Forenede Stater, 90503
        • Rekruttering
        • Macula Retina Vitreous Institute
        • Kontakt:
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32216
        • Rekruttering
        • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
        • Kontakt:
      • Sarasota, Florida, Forenede Stater, 34239
        • Rekruttering
        • Sarasota Retina Institute
        • Kontakt:
      • Wesley Chapel, Florida, Forenede Stater, 33544
        • Rekruttering
        • SEASHORE RETINA LLC DBA Retina Specialists of Tampa
        • Kontakt:
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30909
        • Rekruttering
        • Southeast Retina Center, P.C.
        • Kontakt:
      • Sandy Springs, Georgia, Forenede Stater, 30328
        • Rekruttering
        • Thomas Eye Group
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rekruttering
        • Rush University Medical Center
        • Kontakt:
      • Chicago, Illinois, Forenede Stater, 60611
      • Chicago, Illinois, Forenede Stater, 60612
        • Rekruttering
        • UIC - Department of Ophthalmology and Visual Sciences
        • Kontakt:
          • Jennifer I Lim, MD
          • Telefonnummer: 312-355-3743
          • E-mail: jiashe@uic.edu
      • Oak Park, Illinois, Forenede Stater, 60304
        • Rekruttering
        • Illinois Retina Associates SC - Oak Park Site
        • Kontakt:
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46290
        • Rekruttering
        • Raj K. Maturi, M.D., P.C.
        • Kontakt:
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66211
        • Rekruttering
        • Mid-America Retina Consultants, P.A.
        • Kontakt:
      • Prairie Village, Kansas, Forenede Stater, 66208
        • Rekruttering
        • University of Kansas Medical Center Research Institute, Inc.
        • 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, 21287
        • Rekruttering
        • Johns Hopkins University
        • Kontakt:
          • Sharon D. Solomon, MD
          • Telefonnummer: 410-614-6908
          • E-mail: mfrey3@jhmi.edu
      • Baltimore, Maryland, Forenede Stater, 21237
        • Rekruttering
        • Elman Retina Group, P.A.
        • Kontakt:
    • Massachusetts
      • Ayer, Massachusetts, Forenede Stater, 01432
      • Boston, Massachusetts, Forenede Stater, 02215
    • Michigan
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Rekruttering
        • Retina Associates of Michigan
        • Kontakt:
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201-5276
      • St Louis, Missouri, Forenede Stater, 63128-1729
        • Rekruttering
        • Retina Research Institute, LLC
        • Kontakt:
    • New York
      • Liverpool, New York, Forenede Stater, 13088
        • Rekruttering
        • Retina-Vitreous Surgeons of Central NY, PC
        • Kontakt:
      • Rochester, New York, Forenede Stater, 14620-4655
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27517
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Kontakt:
    • Oklahoma
      • Edmond, Oklahoma, Forenede Stater, 73013-9791
        • Rekruttering
        • Retina Vitreous Center
        • Kontakt:
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Rekruttering
        • Verum Research LLC
        • Kontakt:
      • Springfield, Oregon, Forenede Stater, 97477
    • Pennsylvania
      • Monroeville, Pennsylvania, Forenede Stater, 15146
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
      • Sewickley, Pennsylvania, Forenede Stater, 15143
        • Rekruttering
        • Pittsburg Clinical Trial Consortium
        • Kontakt:
    • South Carolina
      • Hilton Head Island, South Carolina, Forenede Stater, 29926
        • Rekruttering
        • Hilton Head Retina Institute
        • Kontakt:
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57108
        • Rekruttering
        • Ophthalmology Ltd.
        • Kontakt:
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Rekruttering
        • Vanderbilt Eye Institute
        • Kontakt:
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Rekruttering
        • Austin Research Center for Retina
        • Kontakt:
      • Bellaire, Texas, Forenede Stater, 77401
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • Kontakt:
      • Lubbock, Texas, Forenede Stater, 79424
        • Rekruttering
        • Texas Retina Associates
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78240
        • Rekruttering
        • Retinal Consultants of San Antonio
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • The University of Texas Health Science Center at San Antonio
        • Kontakt:
    • Virginia
      • Reston, Virginia, Forenede Stater, 20190
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
        • Rekruttering
        • Spokane Eye Clinical Research, PLLC
        • 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

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Øjeblikkelig Vitrektomi
Procedure: Immediate Vitrectomy

Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Andet: Udskudt Vitrektomi
Procedure: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

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

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

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)

22. februar 2022

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

1. december 2021

Først indsendt, der opfyldte QC-kriterier

1. december 2021

Først opslået (Faktiske)

6. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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