Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Epiretinal Membrane Clinical Trial

— Protocol AM  

Official title:

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145491
• Other study ID #: DRCR.net Protocol AM
• Secondary ID: UG1EY014231
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

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

Locations

Country	Name	City	State
United States	Southeast Retina Center, P.C.	Augusta	Georgia
United States	Austin Research Center for Retina	Austin	Texas
United States	Valley Eye Physicians and Surgeons	Ayer	Massachusetts
United States	Elman Retina Group, P.A.	Baltimore	Maryland
United States	Johns Hopkins University	Baltimore	Maryland
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Retina Vitreous Center	Edmond	Oklahoma
United States	Verum Research LLC	Eugene	Oregon
United States	Kent W. Small, MD, AMC	Glendale	California
United States	Hilton Head Retina Institute	Hilton Head Island	South Carolina
United States	Baylor College of Medicine, Baylor Eye Physicians and Surgeons	Houston	Texas
United States	Salehi Retina Institute Inc.	Huntington Beach	California
United States	Raj K. Maturi, M.D., P.C.	Indianapolis	Indiana
United States	Florida Retina Institute, James A. Staman, MD, PA- Jacksonville	Jacksonville	Florida
United States	Retina-Vitreous Surgeons of Central NY, PC	Liverpool	New York
United States	Loma Linda University	Loma Linda	California
United States	Texas Retina Associates	Lubbock	Texas
United States	Retina-Vitreous Consultants, Inc.	Monroeville	Pennsylvania
United States	Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.	Mountain View	California
United States	Illinois Retina Associates SC - Oak Park Site	Oak Park	Illinois
United States	East Bay Retina Consultants, Inc.	Oakland	California
United States	Mid-America Retina Consultants, P.A.	Overland Park	Kansas
United States	The Trustees of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Retina Associates of Western NY, P.C.	Rochester	New York
United States	Regents of the University of California, Davis, DBA University of California, Davis	Sacramento	California
United States	Retina Research Institute, LLC	Saint Louis	Missouri
United States	Retinal Consultants of San Antonio	San Antonio	Texas
United States	Thomas Eye Group	Sandy Springs	Georgia
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Pittsburg Clinical Trial Consortium	Sewickley	Pennsylvania
United States	Spokane Eye Clinical Research, PLLC	Spokane	Washington
United States	Cascade Medical Research Institute, LLC	Springfield	Oregon
United States	Macula Retina Vitreous Institute	Torrance	California
United States	SEASHORE RETINA LLC DBA Retina Specialists of Tampa	Wesley Chapel	Florida
United States	Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana	West Monroe	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	Juvenile Diabetes Research Foundation, National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 36 months