Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

This study is comparing two approaches for treating epiretinal membrane (ERM), a condition affecting your vision. One group will have Immediate Vitrectomy (surgery to remove the ERM) within one month. The other group will have Deferred Vitrectomy, meaning surgery will only happen if their vision significantly worsens. The goal is to see if performing surgery sooner leads to better vision over 36 months compared to waiting. You may be able to join if you are at least 45 years old, have good vision (20/40 or better), and your ERM is believed to be the main cause of any vision problems or distortion you experience. The study aims to enroll 400 participants.

Study design
This is an interventional, randomized study comparing two treatment approaches. It plans to enroll 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 36 months after starting the study.

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NCT05145491

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Recruiting
NAAges 50+InterventionalTreatment
Jaeb Center for Health Research
~400 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Immediate VitrectomyDeferred Vitrectomy

At a glance

Recruiting sites
48 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in visual acuity letter score from baseline to 36 months
Measured over Baseline to 36 months
Epiretinal Membrane
48 sites across 24 states
California7
Texas5
Illinois4
Florida3
Pennsylvania3
Georgia2
Kansas2
Maryland2

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Eligibility criteria

Inclusion

Age ≥ 45 years
E-ETDRS visual acuity 20/40 or better (≥69 letters)
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

Exclusion

History of retinal vascular disease
History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM
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
Macular hole
Degenerative lamellar macular hole
Vitreomacular traction within 1,500 microns of foveal center
Central serous chorioretinopathy
Nonproliferative diabetic retinopathy or worse (DR severity \>20)
  • Mean change in visual acuity letter score from baseline to 36 monthsBaseline 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.