Epiretinal MembraneProtocol AMNCT05145491
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
A study testing Immediate Vitrectomy and Deferred Vitrectomy in people with Epiretinal Membrane, run by Jaeb Center for Health Research at 48 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- Immediate Vitrectomy and Deferred Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 22 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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)
Trial locations and contacts
48 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
48 sites in 2 countries
United States47 sites, 47 recruiting
- Recruiting
Southeast Retina Center, P.C.
Augusta, Georgia, 30909
Dennis M. Marcus, MD, 7066500061, kristen@southeastretina.com
- Recruiting
Austin Research Center for Retina
Austin, Texas, 78705
Chirag Jhaveri, MD, 7377040130, vcadena@retinaofaustin.com
- Recruiting
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, 01432
Gisela Velez, MD,MPH,MA, 9787724000, research@valleyeyephysicians.com
- Recruiting
Elman Retina Group, P.A.
Baltimore, Maryland, 21237
Michael J. Elman, MD, 410-686-3000, Starr@elmanretina.com
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Sharon D. Solomon, MD, 4106146908, mfrey3@jhmi.edu
- Recruiting
Retina Consultants of Texas
Bellaire, Texas, 77401
Charles C. Wykoff, MD, 7135243434, ilsa.ortega@retinaconsultantstexas.com
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Mohamed A. Elmasry, MD, PhD, 617-309-2520, Ann.Kopple@joslin.harvard.edu
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Jan N. Ulrich, MD, 919-966-5296, elizabeth_dubose@med.unc.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Alice T. Lyon, MD, 3126952567, sarah.elhabash@northwestern.edu
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Mathew W. MacCumber, MD, PhD, 3129422117, manaal_pandit@rush.edu
- Recruiting
UIC - Department of Ophthalmology and Visual Sciences
Chicago, Illinois, 60612
Jennifer I Lim, MD, 312-355-3743, jiashe@uic.edu
- Recruiting
The Curators of the University of Missouri
Columbia, Missouri, 65201-5276
Ahmed M. Elkeeb, MD, 573-882-1506, heathermchatton@health.missouri.edu
- Recruiting
Retina Vitreous Center
Edmond, Oklahoma, 73013-9791
Sandeep N. Shah, MD, (405) 607-6699, jessica@rvcoklahoma.com
- Recruiting
Verum Research LLC
Eugene, Oregon, 97401
Albert O. Edwards, MD, PhD, 5417622763, lcarroll@oregonretina.org
- Recruiting
Kent W. Small, MD, AMC
Glendale, California, 91203-1971
Kent W. Small, MD, 818-552-5040, shayafadi@gmail.com
- Recruiting
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
Raafay Sophie, MD, 8104874500, tracy@retinamichigan.com
- Recruiting
Hilton Head Retina Institute
Hilton Head Island, South Carolina, 29926
Carl W. Baker, MD, 8437152424, jdb@hhretina.com
- Recruiting
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, 77030
Christina Y. Weng, MD, MBA, 713-798-3493, Peter.Rico@bcm.edu
- Recruiting
Salehi Retina Institute Inc.
Huntington Beach, California, 92647-8693
Hani Salehi-Had, MD, 657-227-9496, u.boldbaatar@retinasocal.com
- Recruiting
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46290
Raj K. Maturi, MD, 3178171414, sheerazn@midwesteye.com
- Recruiting
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, 32216
Benjamin J. Thomas, MD, 904-997-9202, kareny@floridaretinainstitute.com
- Recruiting
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, 13088
Kevin I. Rosenberg, MD, 315-445-8166, lsienkiewycz@rvscny.com
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Kakarla V. Chalam, MD, 9095582169, nborntrager@llu.edu
- Recruiting
Texas Retina Associates
Lubbock, Texas, 79424
Michel Shami, MD, 806-792-0066, ysaldivar@texasretina.com
- Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146
Karl R. Olsen, MD, 412-683-5300, merlottil@retinapittsburgh.com
- Recruiting
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California, 94040-4123
Rahul N. Khurana, MD, 650-988-7480, jgonzales@ncrva.com
- Recruiting
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Avni P. Finn, MD, MBA, 6159362020, marybeth.l.carter@vumc.org
- Recruiting
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, 60304
Mathew W. MacCumber, MD, PhD, 708-660-8450, saraw@illinoisretina.com
- Recruiting
East Bay Retina Consultants, Inc.
Oakland, California, 94609-3028
Jesse J. Jung, MD, 510-444-1600, hwinje5@hotmail.com
- Recruiting
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, 66211
William N. Rosenthal, MD, (913) 663-5900, sbell@midamericaretina.com
- Recruiting
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alexander J. Brucker, MD, 2156629702, devica.bhutani@pennmedicine.upenn.edu
- Recruiting
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas, 66208
Radwan S. Ajlan, MBBCh, 913-588-0105, amadrigal2@kumc.edu
- Recruiting
The Retina Group of Washington
Reston, Virginia, 20190
Mohsin Ali, MD, 703-698-9335, amcgee@retinacarecenter.com
- Recruiting
Retina Associates of Western NY, P.C.
Rochester, New York, 14620-4655
Matthew T. Witmer, MD, 585-442-3411, myagoda@retinaassociatesofwny.com
- Recruiting
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, 95817
Ala Moshiri, MD, PhD, 9167346074, dcmacias@ucdavis.edu
- Recruiting
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Darrell E. Baskin, MD, 210-615-1311, ladams@retinasanantonio.com
- Recruiting
Thomas Eye Group
Sandy Springs, Georgia, 30328
Paul L. Kaufman, MD, 404-256-1507, kathyw@thomaseye.com
- Recruiting
Sarasota Retina Institute
Sarasota, Florida, 34239
Melvin Chen, MD, 9419215335, srqresearch@aol.com
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Odette M. Houghton, MD, 4803018085, esmeralda-meckelburg.alex@mayo.edu
- Recruiting
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, 15143
Leanne T. Labriola, DO,MBA, 4123015326, sawlcarm@gmail.com
- Recruiting
Ophthalmology Ltd.
Sioux Falls, South Dakota, 57108
Elizabeth A. Atchison, MD, 6053366294, jweisbrod@opltd.com
- Recruiting
Spokane Eye Clinical Research, PLLC
Spokane, Washington, 99204
Shelly T. Lee, 5094360107, dwaidelich@spokaneeye.com
- Recruiting
Cascade Medical Research Institute, LLC
Springfield, Oregon, 97477
Allan A. Hunter, MD, 5416871927, aprice@cascademedicalresearch.com
- Recruiting
Retina Research Institute, LLC
St Louis, Missouri, 63128-1729
Kevin J. Blinder, MD, 314-367-1181, rhonda.weeks@rc-stl.com
- Recruiting
Macula Retina Vitreous Institute
Torrance, California, 90503
Mehran Taban, MD, 4242479090, eceja@mrvcenter.com
- Recruiting
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, 33544
Evan N. Dunn, MD, 813-973-3333, smorris@retinacaretampa.com
- Recruiting
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, 71291-4452
Ruben A. Grigorian, MD, 318-325-2610, sdavid@eyenela.com
United Kingdom1 site, 1 recruiting
- Recruiting
South Tyneside and Sunderland NHS Trust
Sunderland, Tyne and Wear, SR29HP
Maged Habib, +44 191 5699065, steve.dodds@nhs.net
About this study
Official title: 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.
- Conditions
- Epiretinal Membrane
- Being tested
- Immediate Vitrectomy, Deferred Vitrectomy
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate VitrectomyProcedure or surgery
Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Deferred VitrectomyProcedure or surgery
Vitrectomy may be performed only if at least one of the following criteria is met:
- Decrease in visual acuity ≥10 letters from baseline at a single visit presumed to be from ERM
- Decrease in visual acuity ≥5 letters from baseline at two consecutive visits presumed to be from ERM
- Visits must be at least one month apart
- Participant actively requests surgery due to worsening symptoms
- Complication requires prompt surgical intervention (e.g., macular hole, retinal detachment, non-clearing vitreous hemorrhage)
| Study group | Role | What they receive |
|---|---|---|
| Immediate Vitrectomy | Active comparator | Not described Receives: Procedure: Immediate Vitrectomy |
| Deferred Vitrectomy | Other | Not described Receives: Procedure: Deferred Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start22 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145491
- Sponsor's protocol ID
- DRCR.net Protocol AM
- Other IDs
- UG1EY014231
- Acronym
- Protocol AM
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT05145491
- Acronym / sponsor ID
- Protocol AM / DRCR.net Protocol AM
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Vitrectomy | Active comparator | Procedure: Immediate Vitrectomy |
| Deferred Vitrectomy | Other | Procedure: Deferred Vitrectomy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate VitrectomySurgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization | Procedure or surgery | Immediate Vitrectomy |
| Deferred VitrectomyVitrectomy 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) | Procedure or surgery | Deferred Vitrectomy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Vitrectomy and Deferred Vitrectomy in people with Epiretinal Membrane, run by Jaeb Center for Health Research at 48 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in visual acuity letter score from baseline to 36 months (time frame: Baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.