NCT05145491 · Jaeb Center for Health Research
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
(Protocol AM)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Scottsdale, Arizona
- Glendale, California
- Huntington Beach, California
- Loma Linda, California
- Mountain View, California
- Oakland, California
- Sacramento, California
- Torrance, California
- Jacksonville, Florida
- Sarasota, Florida
- Wesley Chapel, Florida
- Augusta, Georgia
And 32 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations