Phase
Condition
N/ATreatment
Deferred Vitrectomy
Immediate Vitrectomy
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 worseningin 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 waitat least 4 weeks to see if vision remains stable without having to proceed tovitrectomy)
No known medical problems that will be a contraindication to surgery
Exclusion
Key Exclusion Criteria:
History of retinal vascular disease
History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused theERM o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage didnot cause the ERM in the investigator's opinion
History of inflammatory disease unless mild and completely resolved at least oneyear 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 ofsubretinal 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)
Study Design
Connect with a study center
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United StatesActive - Recruiting
Kent W. Small, MD, AMC
Glendale, California 91203-1971
United StatesActive - Recruiting
Salehi Retina Institute Inc.
Huntington Beach, California 92647-8693
United StatesActive - Recruiting
Loma Linda University
Loma Linda, California 92354
United StatesActive - Recruiting
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California 94040-4123
United StatesActive - Recruiting
East Bay Retina Consultants, Inc.
Oakland, California 94609-3028
United StatesActive - Recruiting
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California 95817
United StatesActive - Recruiting
Macula Retina Vitreous Institute
Torrance, California 90503
United StatesActive - Recruiting
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida 32216
United StatesActive - Recruiting
Sarasota Retina Institute
Sarasota, Florida 34239
United StatesActive - Recruiting
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida 33544
United StatesActive - Recruiting
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United StatesActive - Recruiting
Thomas Eye Group
Sandy Springs, Georgia 30328
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois 60304
United StatesActive - Recruiting
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana 46290
United StatesActive - Recruiting
Mid-America Retina Consultants, P.A.
Overland Park, Kansas 66211
United StatesActive - Recruiting
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas 66208
United StatesActive - Recruiting
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana 71291-4452
United StatesActive - Recruiting
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesActive - Recruiting
Valley Eye Physicians and Surgeons
Ayer, Massachusetts 01432
United StatesActive - Recruiting
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Retina Associates of Michigan
Grand Blanc, Michigan 48439
United StatesActive - Recruiting
The Curators of the University of Missouri
Columbia, Missouri 65201-5276
United StatesActive - Recruiting
Retina Research Institute, LLC
Saint Louis, Missouri 63128-1729
United StatesActive - Recruiting
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York 13088
United StatesActive - Recruiting
Retina Associates of Western NY, P.C.
Rochester, New York 14620-4655
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27517
United StatesActive - Recruiting
Retina Vitreous Center
Edmond, Oklahoma 73013-9791
United StatesActive - Recruiting
Verum Research LLC
Eugene, Oregon 97401
United StatesActive - Recruiting
Cascade Medical Research Institute, LLC
Springfield, Oregon 97477
United StatesActive - Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania 15146
United StatesActive - Recruiting
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania 15143
United StatesActive - Recruiting
Hilton Head Retina Institute
Hilton Head Island, South Carolina 29926
United StatesActive - Recruiting
Vanderbilt Eye Institute
Nashville, Tennessee 37232
United StatesActive - Recruiting
Austin Research Center for Retina
Austin, Texas 78705
United StatesActive - Recruiting
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesActive - Recruiting
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas 77030
United StatesActive - Recruiting
Texas Retina Associates
Lubbock, Texas 79424
United StatesActive - Recruiting
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United StatesActive - Recruiting
Spokane Eye Clinical Research, PLLC
Spokane, Washington 99204
United StatesActive - Recruiting
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