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NCT Number: NCT05145491

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

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.

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Key information

Conditions

Epiretinal Membrane Eye Diseases Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Tyneside and Sunderland NHS Trust, Sunderland, Tyne and Wear, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immediate Vitrectomy

Procedure

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

Deferred Vitrectomy

Procedure

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

a. 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)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

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

Registry information

Official study title

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Acronym: Protocol AM

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Dec 6, 2021
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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