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RECRUITING

NCT05145491

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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.

Official title: Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2022-02-22

Completion Date

2026-12-31

Last Updated

2026-01-28

Healthy Volunteers

Conditions

Epiretinal Membrane

Interventions

PROCEDURE

Immediate Vitrectomy

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

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)

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)

Locations (46)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Kent W. Small, MD, AMC

Glendale, California, United States

Salehi Retina Institute Inc.

Huntington Beach, California, United States

Loma Linda University

Loma Linda, California, United States

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

Mountain View, California, United States

East Bay Retina Consultants, Inc.

Oakland, California, United States

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

Sacramento, California, United States

Macula Retina Vitreous Institute

Torrance, California, United States

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

Jacksonville, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

SEASHORE RETINA LLC DBA Retina Specialists of Tampa

Wesley Chapel, Florida, United States

Southeast Retina Center, P.C.

Augusta, Georgia, United States

Thomas Eye Group

Sandy Springs, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Illinois Retina Associates SC - Oak Park Site

Oak Park, Illinois, United States

Raj K. Maturi, M.D., P.C.

Indianapolis, Indiana, United States

Mid-America Retina Consultants, P.A.

Overland Park, Kansas, United States

University of Kansas Medical Center Research Institute, Inc.

Prairie Village, Kansas, United States

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

West Monroe, Louisiana, United States

Elman Retina Group, P.A.

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Retina Associates of Michigan

Grand Blanc, Michigan, United States

The Curators of the University of Missouri

Columbia, Missouri, United States

Retina Research Institute, LLC

St Louis, Missouri, United States

Retina-Vitreous Surgeons of Central NY, PC

Liverpool, New York, United States

Retina Associates of Western NY, P.C.

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Retina Vitreous Center

Edmond, Oklahoma, United States

Verum Research LLC

Eugene, Oregon, United States

Cascade Medical Research Institute, LLC

Springfield, Oregon, United States

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania, United States

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pittsburg Clinical Trial Consortium

Sewickley, Pennsylvania, United States

Hilton Head Retina Institute

Hilton Head Island, South Carolina, United States

Ophthalmology Ltd.

Sioux Falls, South Dakota, United States

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Austin Research Center for Retina

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Baylor College of Medicine, Baylor Eye Physicians and Surgeons

Houston, Texas, United States

Texas Retina Associates

Lubbock, Texas, United States

Retinal Consultants of San Antonio

San Antonio, Texas, United States

Spokane Eye Clinical Research, PLLC

Spokane, Washington, United States

South Tyneside and Sunderland NHS Trust

Sunderland, Tyne and Wear, United Kingdom