Recruiting

Immediate vs. Deferred

Sponsor:

Jaeb Center for Health Research

Code:

NCT05145491

Conditions

Epiretinal Membrane

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Immediate Vitrectomy

Deferred Vitrectomy

Study Details

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

Study ID

NCT05145491

Start date

Feb 22, 2022

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Immediate Vitrectomy

other: Deferred Vitrectomy

Interventions

Immediate Vitrectomy

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

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)

Primary outcome measure

  • Mean change in visual acuity letter score from baseline to 36 months [ Time Frame: Baseline to 36 months ]

Central Contacts and Locations

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Odette M. Houghton, MD

4803018085esmeralda-meckelburg.alex@mayo.edu

Kent W. Small, MD, AMC

Recruiting

Glendale, California, United States, 91203-1971

Contacts

Kent W. Small, MD

818-552-5040shayafadi@gmail.com

Salehi Retina Institute Inc.

Recruiting

Huntington Beach, California, United States, 92647-8693

Contacts

Hani Salehi-Had, MD

657-227-9496u.boldbaatar@retinasocal.com

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Kakarla V. Chalam, MD

9095582169nborntrager@llu.edu

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

Recruiting

Mountain View, California, United States, 94040-4123

Contacts

Rahul N. Khurana, MD

650-988-7480jgonzales@ncrva.com

East Bay Retina Consultants, Inc.

Recruiting

Oakland, California, United States, 94609-3028

Contacts

Jesse J. Jung, MD

510-444-1600hwinje5@hotmail.com

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

Recruiting

Sacramento, California, United States, 95817

Contacts

Ala Moshiri, MD, PhD

9167346074dcmacias@ucdavis.edu

Macula Retina Vitreous Institute

Recruiting

Torrance, California, United States, 90503

Contacts

Mehran Taban, MD

4242479090eceja@mrvcenter.com

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

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Benjamin J. Thomas, MD

904-997-9202kareny@floridaretinainstitute.com

Sarasota Retina Institute

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Melvin Chen, MD

9419215335srqresearch@aol.com

SEASHORE RETINA LLC DBA Retina Specialists of Tampa

Recruiting

Wesley Chapel, Florida, United States, 33544

Contacts

Evan N. Dunn, MD

813-973-3333smorris@retinacaretampa.com

Southeast Retina Center, P.C.

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Dennis M. Marcus, MD

7066500061kristen@southeastretina.com

Thomas Eye Group

Recruiting

Sandy Springs, Georgia, United States, 30328

Contacts

Paul L. Kaufman, MD

404-256-1507kathyw@thomaseye.com

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Alice T. Lyon, MD

3126952567sarah.elhabash@northwestern.edu

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Mathew W. MacCumber, MD, PhD

3129422117manaal_pandit@rush.edu

UIC - Department of Ophthalmology and Visual Sciences

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jennifer I Lim, MD

312-355-3743jiashe@uic.edu

Illinois Retina Associates SC - Oak Park Site

Recruiting

Oak Park, Illinois, United States, 60304

Contacts

Mathew W. MacCumber, MD, PhD

708-660-8450saraw@illinoisretina.com

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

Recruiting

Indianapolis, Indiana, United States, 46290

Contacts

Raj K. Maturi, MD

3178171414sheerazn@midwesteye.com

Mid-America Retina Consultants, P.A.

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

William N. Rosenthal, MD

(913) 663-5900sbell@midamericaretina.com

University of Kansas Medical Center Research Institute, Inc.

Recruiting

Prairie Village, Kansas, United States, 66208

Contacts

Radwan S. Ajlan, MBBCh

913-588-0105amadrigal2@kumc.edu

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

Recruiting

West Monroe, Louisiana, United States, 71291-4452

Contacts

Ruben A. Grigorian, MD

318-325-2610sdavid@eyenela.com

Elman Retina Group, P.A.

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Michael J. Elman, MD

410-686-3000Starr@elmanretina.com

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Sharon D. Solomon, MD

4106146908mfrey3@jhmi.edu

Valley Eye Physicians and Surgeons

Recruiting

Ayer, Massachusetts, United States, 01432

Contacts

Gisela Velez, MD,MPH,MA

9787724000research@valleyeyephysicians.com

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Mohamed A. Elmasry, MD, PhD

617-309-2520Ann.Kopple@joslin.harvard.edu

Retina Associates of Michigan

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Raafay Sophie, MD

8104874500tracy@retinamichigan.com

The Curators of the University of Missouri

Recruiting

Columbia, Missouri, United States, 65201-5276

Contacts

Ahmed M. Elkeeb, MD

573-882-1506heathermchatton@health.missouri.edu

Retina Research Institute, LLC

Recruiting

St Louis, Missouri, United States, 63128-1729

Contacts

Kevin J. Blinder, MD

314-367-1181rhonda.weeks@rc-stl.com

Retina-Vitreous Surgeons of Central NY, PC

Recruiting

Liverpool, New York, United States, 13088

Contacts

Kevin I. Rosenberg, MD

315-445-8166lsienkiewycz@rvscny.com

Retina Associates of Western NY, P.C.

Recruiting

Rochester, New York, United States, 14620-4655

Contacts

Matthew T. Witmer, MD

585-442-3411myagoda@retinaassociatesofwny.com

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27517

Contacts

Jan N. Ulrich, MD

919-966-5296elizabeth_dubose@med.unc.edu

Retina Vitreous Center

Recruiting

Edmond, Oklahoma, United States, 73013-9791

Contacts

Sandeep N. Shah, MD

(405) 607-6699jessica@rvcoklahoma.com

Verum Research LLC

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Albert O. Edwards, MD, PhD

5417622763lcarroll@oregonretina.org

Cascade Medical Research Institute, LLC

Recruiting

Springfield, Oregon, United States, 97477

Contacts

Allan A. Hunter, MD

5416871927aprice@cascademedicalresearch.com

Retina-Vitreous Consultants, Inc.

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Karl R. Olsen, MD

412-683-5300merlottil@retinapittsburgh.com

The Trustees of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alexander J. Brucker, MD

2156629702devica.bhutani@pennmedicine.upenn.edu

Pittsburg Clinical Trial Consortium

Recruiting

Sewickley, Pennsylvania, United States, 15143

Contacts

Leanne T. Labriola, DO,MBA

4123015326sawlcarm@gmail.com

Hilton Head Retina Institute

Recruiting

Hilton Head Island, South Carolina, United States, 29926

Contacts

Carl W. Baker, MD

8437152424jdb@hhretina.com

Ophthalmology Ltd.

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Elizabeth A. Atchison, MD

6053366294jweisbrod@opltd.com

Vanderbilt Eye Institute

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Avni P. Finn, MD, MBA

6159362020marybeth.l.carter@vumc.org

Austin Research Center for Retina

Recruiting

Austin, Texas, United States, 78705

Contacts

Chirag Jhaveri, MD

7377040130vcadena@retinaofaustin.com

Retina Consultants of Texas

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Charles C. Wykoff, MD

7135243434ilsa.ortega@retinaconsultantstexas.com

Baylor College of Medicine, Baylor Eye Physicians and Surgeons

Recruiting

Houston, Texas, United States, 77030

Contacts

Christina Y. Weng, MD, MBA

713-798-3493Peter.Rico@bcm.edu

Texas Retina Associates

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Michel Shami, MD

806-792-0066ysaldivar@texasretina.com

Retinal Consultants of San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Darrell E. Baskin, MD

210-615-1311ladams@retinasanantonio.com

The Retina Group of Washington

Recruiting

Reston, Virginia, United States, 20190

Contacts

Mohsin Ali, MD

703-698-9335amcgee@retinacarecenter.com

Spokane Eye Clinical Research, PLLC

Recruiting

Spokane, Washington, United States, 99204

Contacts

Shelly T. Lee

5094360107dwaidelich@spokaneeye.com

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Jul 16, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-07-16.