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

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Procedure: Immediate Vitrectomy Procedure: Deferred Vitrectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Actual Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immediate Vitrectomy	Procedure: Immediate Vitrectomy Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Other: Deferred Vitrectomy	Procedure: 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)

Arm

Intervention/Treatment

Active Comparator: Immediate Vitrectomy

Procedure: Immediate Vitrectomy

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

Other: Deferred Vitrectomy

Procedure: 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)

Outcome Measures

Primary Outcome Measures

Mean change in visual acuity letter score from baseline to 36 months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Visual acuity 20/25 to 20/40

o Epiretinal membrane (ERM) must be thought to be the primary cause of vision loss

ERM meeting the following criteria
Symptoms of visual loss and/or distortion (and 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 optical coherence tomography (OCT)
Distortion within the central subfield by 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:

Secondary ERM due to retinal vascular disease, vitreous hemorrhage, retinal detachment, inflammatory disease, or associations other than vitreous syneresis, retinal break, or posterior vitreous detachment

History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion
Prior retinal tears treated with laser or cryosurgical retinopexy are permitted provided the laser or cryosurgical retinopexy is completed at least one month prior to randomization

Prior intraocular surgery (except uncomplicated cataract extraction)
Cataract extraction within prior 3 months
History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis
Past or current macular hole or degenerative lamellar macular hole
Vitreomacular traction within 1,500 microns of the foveal center
Central serous chorioretinopathy
Nonproliferative diabetic retinopathy or worse (diabetic retinopathy severity >20)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kent W. Small, MD, AMC	Glendale	California	United States	91203-1971
2	Salehi Retina Institute Inc.	Huntington Beach	California	United States	92647-8693
3	Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.	Mountain View	California	United States	94040-4123
4	East Bay Retina Consultants, Inc.	Oakland	California	United States	94609-3028
5	Florida Retina Institute, James A. Staman, MD, PA- Jacksonville	Jacksonville	Florida	United States	32216
6	Sarasota Retina Institute	Sarasota	Florida	United States	34239
7	SEASHORE RETINA LLC DBA Retina Specialists of Tampa	Wesley Chapel	Florida	United States	33544
8	Thomas Eye Group	Sandy Springs	Georgia	United States	30328
9	Illinois Retina Associates SC - Oak Park Site	Oak Park	Illinois	United States	60304
10	Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana	West Monroe	Louisiana	United States	71291-4452
11	Elman Retina Group, P.A.	Baltimore	Maryland	United States	21237
12	Joslin Diabetes Center	Boston	Massachusetts	United States	02215
13	Retina Research Institute, LLC	Saint Louis	Missouri	United States	63128-1729
14	Retina-Vitreous Surgeons of Central NY, PC	Liverpool	New York	United States	13088
15	Retina Associates of Western NY, P.C.	Rochester	New York	United States	14620-4655
16	Retina Vitreous Center	Edmond	Oklahoma	United States	73013-9791
17	Hilton Head Retina Institute	Hilton Head Island	South Carolina	United States	29926
18	Texas Retina Associates	Lubbock	Texas	United States	79424
19	Retinal Consultants of San Antonio	San Antonio	Texas	United States	78240

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jaeb Center for Health Research

ClinicalTrials.gov Identifier:

NCT05145491

Other Study ID Numbers:

DRCR.net Protocol AM
UG1EY014231

First Posted:

Dec 6, 2021

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epiretinal Membrane

Study Results

No Results Posted as of Aug 18, 2022