Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

NCT05145491 | Recruiting DMC

• 2 other identifiers: DRCR.net Protocol AMUG1EY014231
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 46

Brief 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.

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

• Mean change in visual acuity letter score from 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

Study Arms (2)

Immediate Vitrectomy

ACTIVE COMPARATOR

Procedure: Immediate Vitrectomy

Deferred Vitrectomy

OTHER

Procedure: Deferred Vitrectomy

Interventions

Deferred Vitrectomy PROCEDURE

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)

Deferred Vitrectomy

Immediate Vitrectomy PROCEDURE

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

Immediate Vitrectomy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (46)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Kent W. Small, MD, AMC

Glendale, California, 91203-1971, United States

RECRUITING

Salehi Retina Institute Inc.

Huntington Beach, California, 92647-8693, United States

RECRUITING

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

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

Mountain View, California, 94040-4123, United States

RECRUITING

East Bay Retina Consultants, Inc.

Oakland, California, 94609-3028, United States

RECRUITING

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

Sacramento, California, 95817, United States

RECRUITING

Macula Retina Vitreous Institute

Torrance, California, 90503, United States

RECRUITING

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

Jacksonville, Florida, 32216, United States

RECRUITING

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

RECRUITING

SEASHORE RETINA LLC DBA Retina Specialists of Tampa

Wesley Chapel, Florida, 33544, United States

RECRUITING

Southeast Retina Center, P.C.

Augusta, Georgia, 30909, United States

RECRUITING

Thomas Eye Group

Sandy Springs, Georgia, 30328, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Illinois Retina Associates SC - Oak Park Site

Oak Park, Illinois, 60304, United States

RECRUITING

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

Indianapolis, Indiana, 46290, United States

RECRUITING

Mid-America Retina Consultants, P.A.

Overland Park, Kansas, 66211, United States

RECRUITING

University of Kansas Medical Center Research Institute, Inc.

Prairie Village, Kansas, 66208, United States

RECRUITING

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

West Monroe, Louisiana, 71291-4452, United States

RECRUITING

Elman Retina Group, P.A.

Baltimore, Maryland, 21237, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, 01432, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

Retina Associates of Michigan

Grand Blanc, Michigan, 48439, United States

RECRUITING

The Curators of the University of Missouri

Columbia, Missouri, 65201-5276, United States

RECRUITING

Retina Research Institute, LLC

St Louis, Missouri, 63128-1729, United States

RECRUITING

Retina-Vitreous Surgeons of Central NY, PC

Liverpool, New York, 13088, United States

RECRUITING

Retina Associates of Western NY, P.C.

Rochester, New York, 14620-4655, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

RECRUITING

Retina Vitreous Center

Edmond, Oklahoma, 73013-9791, United States

RECRUITING

Verum Research LLC

Eugene, Oregon, 97401, United States

RECRUITING

Cascade Medical Research Institute, LLC

Springfield, Oregon, 97477, United States

RECRUITING

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania, 15146, United States

RECRUITING

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pittsburg Clinical Trial Consortium

Sewickley, Pennsylvania, 15143, United States

RECRUITING

Hilton Head Retina Institute

Hilton Head Island, South Carolina, 29926, United States

RECRUITING

Ophthalmology Ltd.

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

RECRUITING

Austin Research Center for Retina

Austin, Texas, 78705, United States

RECRUITING

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

RECRUITING

Baylor College of Medicine, Baylor Eye Physicians and Surgeons

Houston, Texas, 77030, United States

RECRUITING

Texas Retina Associates

Lubbock, Texas, 79424, United States

RECRUITING

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

Spokane Eye Clinical Research, PLLC

Spokane, Washington, 99204, United States

RECRUITING

South Tyneside and Sunderland NHS Trust

Sunderland, Tyne and Wear, SR29HP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 6, 2021
• Study Start: February 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (45)