Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM (Protocol AM)

Jaeb Center for Health Research

Status

Enrolling

Conditions

Epiretinal Membrane

Treatments

Procedure: Deferred Vitrectomy

Procedure: Immediate Vitrectomy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05145491

DRCR.net Protocol AM

UG1EY014231 (U.S. NIH Grant/Contract)

Details and patient eligibility

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. 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.

Enrollment

400 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)