Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM

Last updated: February 18, 2025
Sponsor: Jaeb Center for Health Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Deferred Vitrectomy

Immediate Vitrectomy

Clinical Study ID

NCT05145491
DRCR.net Protocol AM
UG1EY014231
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 worseningin 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 waitat least 4 weeks to see if vision remains stable without having to proceed tovitrectomy)

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

Exclusion

Key Exclusion Criteria:

  • History of retinal vascular disease

  • History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused theERM o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage didnot cause the ERM in the investigator's opinion

  • History of inflammatory disease unless mild and completely resolved at least oneyear 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 ofsubretinal 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)

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Deferred Vitrectomy
Phase:
Study Start date:
February 22, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • Kent W. Small, MD, AMC

    Glendale, California 91203-1971
    United States

    Active - Recruiting

  • Salehi Retina Institute Inc.

    Huntington Beach, California 92647-8693
    United States

    Active - Recruiting

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.

    Mountain View, California 94040-4123
    United States

    Active - Recruiting

  • East Bay Retina Consultants, Inc.

    Oakland, California 94609-3028
    United States

    Active - Recruiting

  • Regents of the University of California, Davis, DBA University of California, Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Macula Retina Vitreous Institute

    Torrance, California 90503
    United States

    Active - Recruiting

  • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Sarasota Retina Institute

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • SEASHORE RETINA LLC DBA Retina Specialists of Tampa

    Wesley Chapel, Florida 33544
    United States

    Active - Recruiting

  • Southeast Retina Center, P.C.

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Thomas Eye Group

    Sandy Springs, Georgia 30328
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Illinois Retina Associates SC - Oak Park Site

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana 46290
    United States

    Active - Recruiting

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • University of Kansas Medical Center Research Institute, Inc.

    Prairie Village, Kansas 66208
    United States

    Active - Recruiting

  • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana

    West Monroe, Louisiana 71291-4452
    United States

    Active - Recruiting

  • Elman Retina Group, P.A.

    Baltimore, Maryland 21237
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts 01432
    United States

    Active - Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Retina Associates of Michigan

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • The Curators of the University of Missouri

    Columbia, Missouri 65201-5276
    United States

    Active - Recruiting

  • Retina Research Institute, LLC

    Saint Louis, Missouri 63128-1729
    United States

    Active - Recruiting

  • Retina-Vitreous Surgeons of Central NY, PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Retina Associates of Western NY, P.C.

    Rochester, New York 14620-4655
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

  • Retina Vitreous Center

    Edmond, Oklahoma 73013-9791
    United States

    Active - Recruiting

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Retina-Vitreous Consultants, Inc.

    Monroeville, Pennsylvania 15146
    United States

    Active - Recruiting

  • The Trustees of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Pittsburg Clinical Trial Consortium

    Sewickley, Pennsylvania 15143
    United States

    Active - Recruiting

  • Hilton Head Retina Institute

    Hilton Head Island, South Carolina 29926
    United States

    Active - Recruiting

  • Vanderbilt Eye Institute

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Baylor College of Medicine, Baylor Eye Physicians and Surgeons

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Retina Associates

    Lubbock, Texas 79424
    United States

    Active - Recruiting

  • Retinal Consultants of San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research, PLLC

    Spokane, Washington 99204
    United States

    Active - Recruiting

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