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
South Tyneside and Sunderland NHS Trust
Sunderland 2636531, Tyne and Wear SR29HP
United KingdomActive - Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
Mayo Clinic Arizona
Scottsdale 5313457, Arizona 5551752 85259
United StatesActive - Recruiting
Kent W. Small, MD, AMC
Glendale, California 91203-1971
United StatesSite Not Available
Salehi Retina Institute Inc.
Huntington Beach, California 92647-8693
United StatesSite Not Available
Loma Linda University
Loma Linda, California 92354
United StatesSite Not Available
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California 94040-4123
United StatesSite Not Available
East Bay Retina Consultants, Inc.
Oakland, California 94609-3028
United StatesSite Not Available
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California 95817
United StatesSite Not Available
Macula Retina Vitreous Institute
Torrance, California 90503
United StatesSite Not Available
Kent W. Small, MD, AMC
Glendale 5352423, California 5332921 91203-1971
United StatesActive - Recruiting
Salehi Retina Institute Inc.
Huntington Beach 5358705, California 5332921 92647-8693
United StatesActive - Recruiting
Loma Linda University
Loma Linda 5367696, California 5332921 92354
United StatesActive - Recruiting
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View 5375480, California 5332921 94040-4123
United StatesActive - Recruiting
East Bay Retina Consultants, Inc.
Oakland 5378538, California 5332921 94609-3028
United StatesActive - Recruiting
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
Macula Retina Vitreous Institute
Torrance 5403022, California 5332921 90503
United StatesActive - Recruiting
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida 32216
United StatesSite Not Available
Sarasota Retina Institute
Sarasota, Florida 34239
United StatesSite Not Available
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida 33544
United StatesSite Not Available
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville 4160021, Florida 4155751 32216
United StatesActive - Recruiting
Sarasota Retina Institute
Sarasota 4172131, Florida 4155751 34239
United StatesActive - Recruiting
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel 4177727, Florida 4155751 33544
United StatesActive - Recruiting
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United StatesSite Not Available
Thomas Eye Group
Sandy Springs, Georgia 30328
United StatesSite Not Available
Southeast Retina Center, P.C.
Augusta 4180531, Georgia 4197000 30909
United StatesActive - Recruiting
Thomas Eye Group
Sandy Springs 4221333, Georgia 4197000 30328
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois 60304
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
United StatesActive - Recruiting
Illinois Retina Associates SC - Oak Park Site
Oak Park 4904381, Illinois 4896861 60304
United StatesActive - Recruiting
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana 46290
United StatesSite Not Available
Raj K. Maturi, M.D., P.C.
Indianapolis 4259418, Indiana 4921868 46290
United StatesActive - Recruiting
Mid-America Retina Consultants, P.A.
Overland Park, Kansas 66211
United StatesSite Not Available
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas 66208
United StatesSite Not Available
Mid-America Retina Consultants, P.A.
Overland Park 4276873, Kansas 4273857 66211
United StatesActive - Recruiting
University of Kansas Medical Center Research Institute, Inc.
Prairie Village 4277718, Kansas 4273857 66208
United StatesActive - Recruiting
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana 71291-4452
United StatesSite Not Available
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe 4345850, Louisiana 4331987 71291-4452
United StatesActive - Recruiting
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
Elman Retina Group, P.A.
Baltimore 4347778, Maryland 4361885 21237
United StatesActive - Recruiting
Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Valley Eye Physicians and Surgeons
Ayer, Massachusetts 01432
United StatesSite Not Available
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesSite Not Available
Valley Eye Physicians and Surgeons
Ayer 4929501, Massachusetts 6254926 01432
United StatesActive - Recruiting
Joslin Diabetes Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Retina Associates of Michigan
Grand Blanc, Michigan 48439
United StatesSite Not Available
Retina Associates of Michigan
Grand Blanc 4994320, Michigan 5001836 48439
United StatesActive - Recruiting
The Curators of the University of Missouri
Columbia, Missouri 65201-5276
United StatesSite Not Available
Retina Research Institute, LLC
Saint Louis, Missouri 63128-1729
United StatesSite Not Available
The Curators of the University of Missouri
Columbia 4381982, Missouri 4398678 65201-5276
United StatesActive - Recruiting
Retina Research Institute, LLC
St Louis 4407066, Missouri 4398678 63128-1729
United StatesActive - Recruiting
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York 13088
United StatesSite Not Available
Retina Associates of Western NY, P.C.
Rochester, New York 14620-4655
United StatesSite Not Available
Retina-Vitreous Surgeons of Central NY, PC
Liverpool 5124925, New York 5128638 13088
United StatesActive - Recruiting
Retina Associates of Western NY, P.C.
Rochester 5134086, New York 5128638 14620-4655
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27517
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27517
United StatesActive - Recruiting
Retina Vitreous Center
Edmond, Oklahoma 73013-9791
United StatesSite Not Available
Retina Vitreous Center
Edmond 4535740, Oklahoma 4544379 73013-9791
United StatesActive - Recruiting
Verum Research LLC
Eugene, Oregon 97401
United StatesSite Not Available
Cascade Medical Research Institute, LLC
Springfield, Oregon 97477
United StatesSite Not Available
Verum Research LLC
Eugene 5725846, Oregon 5744337 97401
United StatesActive - Recruiting
Cascade Medical Research Institute, LLC
Springfield 5754005, Oregon 5744337 97477
United StatesActive - Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania 15146
United StatesSite Not Available
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania 15143
United StatesSite Not Available
Retina-Vitreous Consultants, Inc.
Monroeville 5201734, Pennsylvania 6254927 15146
United StatesActive - Recruiting
The Trustees of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Pittsburg Clinical Trial Consortium
Sewickley 5211506, Pennsylvania 6254927 15143
United StatesActive - Recruiting
Hilton Head Retina Institute
Hilton Head Island, South Carolina 29926
United StatesSite Not Available
Hilton Head Retina Institute
Hilton Head Island 4581832, South Carolina 4597040 29926
United StatesActive - Recruiting
Ophthalmology Ltd.
Sioux Falls, South Dakota 57108
United StatesSite Not Available
Ophthalmology Ltd.
Sioux Falls 5231851, South Dakota 5769223 57108
United StatesActive - Recruiting
Vanderbilt Eye Institute
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt Eye Institute
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
Austin Research Center for Retina
Austin, Texas 78705
United StatesSite Not Available
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas 77030
United StatesSite Not Available
Texas Retina Associates
Lubbock, Texas 79424
United StatesSite Not Available
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
Austin Research Center for Retina
Austin 4671654, Texas 4736286 78705
United StatesActive - Recruiting
Retina Consultants of Texas
Bellaire 4673353, Texas 4736286 77401
United StatesActive - Recruiting
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Texas Retina Associates
Lubbock 5525577, Texas 4736286 79424
United StatesActive - Recruiting
Retinal Consultants of San Antonio
San Antonio 4726206, Texas 4736286 78240
United StatesActive - Recruiting
Spokane Eye Clinical Research, PLLC
Spokane, Washington 99204
United StatesSite Not Available
Spokane Eye Clinical Research, PLLC
Spokane 5811696, Washington 5815135 99204
United StatesActive - Recruiting

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