Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM (Protocol AM)

January 27, 2026 updated by: Jaeb Center for Health Research

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Sunderland, Tyne and Wear, United Kingdom, SR29HP
        • Recruiting
        • South Tyneside and Sunderland NHS Trust
        • Contact:
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Glendale, California, United States, 91203-1971
        • Recruiting
        • Kent W. Small, MD, AMC
        • Contact:
      • Huntington Beach, California, United States, 92647-8693
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Contact:
      • Mountain View, California, United States, 94040-4123
        • Recruiting
        • Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
        • Contact:
      • Oakland, California, United States, 94609-3028
        • Recruiting
        • East Bay Retina Consultants, Inc.
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • Regents of the University of California, Davis, DBA University of California, Davis
        • Contact:
      • Torrance, California, United States, 90503
        • Recruiting
        • Macula Retina Vitreous Institute
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Retina Institute
        • Contact:
      • Wesley Chapel, Florida, United States, 33544
        • Recruiting
        • SEASHORE RETINA LLC DBA Retina Specialists of Tampa
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30909
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Thomas Eye Group
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
      • Chicago, Illinois, United States, 60611
      • Oak Park, Illinois, United States, 60304
        • Recruiting
        • Illinois Retina Associates SC - Oak Park Site
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • Raj K. Maturi, M.D., P.C.
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Mid-America Retina Consultants, P.A.
        • Contact:
      • Prairie Village, Kansas, United States, 66208
        • Recruiting
        • University of Kansas Medical Center Research Institute, Inc.
        • Contact:
    • Louisiana
      • West Monroe, Louisiana, United States, 71291-4452
        • Recruiting
        • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Elman Retina Group, P.A.
        • Contact:
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Recruiting
        • Retina Associates of Michigan
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65201-5276
      • St Louis, Missouri, United States, 63128-1729
        • Recruiting
        • Retina Research Institute, LLC
        • Contact:
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina-Vitreous Surgeons of Central NY, PC
        • Contact:
      • Rochester, New York, United States, 14620-4655
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013-9791
        • Recruiting
        • Retina Vitreous Center
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research LLC
        • Contact:
      • Springfield, Oregon, United States, 97477
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
      • Philadelphia, Pennsylvania, United States, 19104
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Pittsburg Clinical Trial Consortium
        • Contact:
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Recruiting
        • Hilton Head Retina Institute
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Ophthalmology Ltd.
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Research Center for Retina
        • Contact:
      • Bellaire, Texas, United States, 77401
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • Contact:
      • Lubbock, Texas, United States, 79424
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retinal Consultants of San Antonio
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Spokane Eye Clinical Research, PLLC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Vitrectomy
Procedure: Immediate Vitrectomy
Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Other: Deferred Vitrectomy
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in visual acuity letter score from baseline to 36 months
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRCR.net Protocol AM
  • UG1EY014231 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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