Clinical trial NCT05145491: Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM
Official title: Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
name: Juvenile Diabetes Research Foundation
First posted: 2021-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Mean change in visual acuity letter score from baseline to 36 months
timeFrame: Baseline to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Glendale
country: United States
facility: Kent W. Small, MD, AMC
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Mountain View
country: United States
facility: Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants, Inc.
state: California
city: Sacramento
country: United States
facility: Regents of the University of California, Davis, DBA University of California, Davis
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Institute
state: California
city: Jacksonville
country: United States
facility: Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Wesley Chapel
country: United States
facility: SEASHORE RETINA LLC DBA Retina Specialists of Tampa
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, P.C.
state: Georgia
city: Sandy Springs
country: United States
facility: Thomas Eye Group
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates SC - Oak Park Site
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, M.D., P.C.
state: Indiana
city: Overland Park
country: United States
facility: Mid-America Retina Consultants, P.A.
state: Kansas
city: Prairie Village
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: West Monroe
country: United States
facility: Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Elman Retina Group, P.A.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ayer
country: United States
facility: Valley Eye Physicians and Surgeons
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Grand Blanc
country: United States
facility: Retina Associates of Michigan
state: Michigan
city: Columbia
country: United States
facility: The Curators of the University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Retina Research Institute, LLC
state: Missouri
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central NY, PC
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY, P.C.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute, LLC
state: Oregon
city: Monroeville
country: United States
facility: Retina-Vitreous Consultants, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Trustees of the University of Pennsylvania
state: Pennsylvania
city: Sewickley
country: United States
facility: Pittsburg Clinical Trial Consortium
state: Pennsylvania
city: Hilton Head Island
country: United States
facility: Hilton Head Retina Institute
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Baylor Eye Physicians and Surgeons
state: Texas
city: Lubbock
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Spokane
country: United States
facility: Spokane Eye Clinical Research, PLLC
state: Washington
Study officials:
References: