Last updated on December 2016

Treatment for CI-DME in Eyes With Very Good VA Study


Brief description of study

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens. The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF. Secondary objectives include: - Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity - For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment - Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness - Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups - Comparing safety outcomes between treatment groups - Comparing associated treatment and follow-up exam costs between treatment groups

Clinical Study Identifier: NCT01909791

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Ramin Schadlu, MD

Arizona Retina and Vitreous Consultants
Phoenix, AZ United States
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John B. Christoforidis, MD

University of Arizona Medical Center/Department of Ophthalmology
Tucson, AZ United States
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Sami Uwaydat, MD

Jones Eye Institute/University of Arkansas for Medical Sciences
Little Rock, AR United States
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Amr Dessouki, MD

Retinal Diagnostic Center
Campbell, CA United States
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Joseph T. Fan, M.D.

Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, CA United States
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Julie Gasperini

South Coast Retina Center
Long Beach, CA United States
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Clement K. Chan, M.D., FACS

Southern California Desert Retina Consultants, MC
Palm Desert, CA United States
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Richard Pesavento, MD

Retina Consultants of Southern California
Redlands, CA United States
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Margaret Chang, MD, MS

Retinal Consultants Medical Group, Inc.
Sacramento, CA United States
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Dante J. Pieramici, M.D.

California Retina Consultants
Santa Barbara, CA United States
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Stewart A. Daniels, M.D.

Bay Area Retina Associates
Walnut Creek, CA United States
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Kenneth R Diddie, MD

Retinal Consultants of Southern California Medical Group, Inc.
Westlake Village, CA United States
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Nauman A. Chaudhry, MD

Retina Group of New England
New London, CT United States
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Nauman Chaudhry, MD

New England Retina Associates
Norwich, CT United States
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Glenn Wing

National Ophthalmic Research Institute
Ft. Myers, FL United States
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Kakarla V. Chalam, M.D., PhD

University of Florida College of Med., Department of Ophthalmology
Jacksonville, FL United States
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Scott Friedman

Florida Retina Consultants
Lakeland, FL United States
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Gary Shienbaum, MD

Retina Macula Specialists of Miami
Miami, FL United States
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Justin H. Townsend, MD

Bascom Palmer Eye Institute
Miami, FL United States
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Chander N Samy, md

Ocala Eye Retina Consultants
Ocala, FL United States
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John T Lehr, MD

Magruder Eye Institute
Orlando, FL United States
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Stuart K Burgess, MD

Fort Lauderdale Eye Institute
Plantation, FL United States
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Michael B Parrot, MD, PhD

Center for Sight
Sarasota, FL United States
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Melvin Chen

Sarasota Retina Institute
Sarasota, FL United States
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Ivan Suner, MD

Retina Associates of Florida, P.A.
Tampa, FL United States
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Andrew M. Hendrick, MD

Emory Eye Center
Atlanta, GA United States
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Dennis Marcus

Southeast Retina Center, P.C.
Augusta, GA United States
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Annal D Meleth, MD, MS

Marietta Eye Clinic
Marietta, GA United States
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Paul Kaufman, MD

Thomas Eye Group
Sandy Springs, GA United States
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Alice T. Lyon, MD

Northwestern Medical Faculty Foundation
Chicago, IL United States
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Jennifer I. Lim, M.D.

University of Illinois at Chicago Medical Center
Chicago, IL United States
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Manvi Maker, MD

NorthShore University HealthSystem
Glenview, IL United States
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Matthew MacCumber, M.D.

Illinois Retina Associates
Joliet, IL United States
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Veeral Sheth, MD, FACS

University Retina and Macula Associates
Oak Forest, IL United States
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Leanne T Labriola, DO

Carle Foundation Hospital
Urbana, IL United States
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Raj Maturi

Raj Maturi
Indianapolis, IN United States
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Howard S. Lazarus, M.D.

John-Kenyon American Eye Institute
New Albany, IN United States
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Michael Scott

Medical Associates Clinic, P.C.
Dubuque, IA United States
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Jared Nielsen

Wolfe Eye Clinic
West Des Moines, IA United States
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Ajay Singh, MD

University of Kansas Medical Center, Dept. of Ophthalmology
Prairie Village, KS United States
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Gregory Fox

Retina Associates, P.A.
Shawnee Mission, KS United States
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Thomas W. Stone, M.D.

Retina and Vitreous Associates of Kentucky
Lexington, KY United States
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Carl W. Baker, M.D.

Paducah Retinal Center
Paducah, KY United States
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Michael Elman

Elman Retina Group, P.A.
Baltimore, MD United States
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Sharon Solomon, M.D.

Wilmer Eye Institute at Johns Hopkins
Baltimore, MD United States
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George S. Sharuk, MD

Joslin Diabetes Center
Boston, MA United States
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Frank J McCabe, MD

Vitreo-Retinal Associates, PC
Worcester, MA United States
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Grant Comer, MD

Kellogg Eye Center, University of Michigan
Ann Arbor, MI United States
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Paul Edward

Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, MI United States
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Robin Ross

Retina Vitreous Center
Grand Blanc, MI United States
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Thomas Aaberg, MD

Retina Specialists of Michigan
Grand Rapids, MI United States
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Louis Glazer

Vitreo-Retinal Associates
Grand Rapids, MI United States
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Sundhar R. Ramasamy, MD

Andersen Eye Associates
Saginaw, MI United States
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Abdhish Bhavsar, M.D.

Retina Center, PA
Minneapolis, MN United States
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Todd R. Klesert, M.D., Ph.D.

University of Minnesota
Minneapolis, MN United States
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Andrew Barkmeier, MD

Mayo Clinic Department of Ophthalmology
Rochester, MN United States
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William N Rosenthal, MD

Mid-America Retina Consultants, P.A.
Kansas City, MO United States
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Kevin Blinder

The Retina Institute
St. Louis, MO United States
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Richard Chace

Eyesight Ophthalmic Services, PA
Portsmouth, NH United States
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Neelakshi Bhagat, MD, MPH

The Institute of Ophthalmology and Visual Science (IOVS)
Newark, NJ United States
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Brett Foxman, MD

Retinal and Ophthalmic Consultants, PC
Northfield, NJ United States
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Mark Chiu, MD

Eye Associates of New Mexico
Albuquerque, NM United States
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Pradeepa Yoganathan, MD

Ross Eye Institute, SUNY Buffalo
Buffalo, NY United States
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Ronald G. Gentile, M.D.

The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, NY United States
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Daniel Rosberger, MD

MaculaCare
New York, NY United States
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Steven Rose, MD

Retina Associates of Western New York
Rochester, NY United States
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David A. DiLoreto, M.D., Ph.D.

University of Rochester
Rochester, NY United States
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G. R. Hampton, M.D.

Retina-Vitreous Surgeons of Central New York, PC
Syracuse, NY United States
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Cameron Stone

Western Carolina Retinal Associates, PA
Asheville, NC United States
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Seema Garg, MD

University of North Carolina
Chapel Hill, NC United States
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David Browning

Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, NC United States
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Michael A Novak, MD

Retina Associates of Cleveland, Inc.
Beachwood, OH United States
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Suber S. Huang, M.D.

Case Western Reserve University
Cleveland, OH United States
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Sandeep Shah, MD

Retina Vitreous Center
Edmond, OK United States
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Albert Edwards, MD

Oregon Retina, LLP
Eugene, OR United States
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Mark A Peters, MD

Retina Northwest, PC
Portland, OR United States
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Andreas K Lauer, M.D.

Casey Eye Institute
Portland, OR United States
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Michael R Pavlica, MD

Family Eye Group
Lancaster, PA United States
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Karl R. Olsen, MD

Retina Vitreous Consultants
Monroeville, PA United States
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Alexander J. Brucker, M.D.

University of Pennsylvania Scheie Eye Institute
Philadelphia, PA United States
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Jeffrey G. Gross, M.D.

Carolina Retina Center
Columbia, SC United States
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John A. Wells, III, MD, ...

Palmetto Retina Center
West Columbia, SC United States
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Richard Breazeale, MD

Southeastern Retina Associates
Chattanooga, TN United States
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Howard L. Cummings, M.D., FACS

Southeastern Retina Associates, PC
Kingsport, TN United States
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Joseph Googe, Jr., M.D.

Southeastern Retina Associates, P.C.
Knoxville, TN United States
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Ryan Rush, MD

Southwest Retina Specialists
Amarillo, TX United States
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Robert Wong

Austin Retina Associates
Austin, TX United States
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Brian Berger

Retina Research Center
Austin, TX United States
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Joseph A Khawly, MD

Retina and Vitreous of Texas
Houston, TX United States
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Petros U Carvounis, MD

Baylor Eye Physicians and Surgeons
Houston, TX United States
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Charles Wykoff

Retina Consultants of Houston, PA
Houston, TX United States
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Michel Shami, M.D.

Texas Retina Associates
Lubbock, TX United States
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Victor H Gonzalez, MD

Valley Retina Institute
McAllen, TX United States
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Calvin E Mein, MD

Retinal Consultants of San Antonio
San Antonio, TX United States
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Robert Kwun, MD

Retina Associates of Utah, P.C.
Salt Lake City, UT United States
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Bryan Schwent

Retina Institute of Virginia
Richmond, VA United States
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Vikram Brar, MD

Virginia Commonwealth University, Dept. of Ophthalmology
Richmond, VA United States
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James L. Kinyoun, M.D.

University of Washington Medical Center
Seattle, WA United States
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Robert S Wirthlin, MD

Spokane Eye Clinic
Spokane, WA United States
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Justin Gottlieb, M.D.

University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, WI United States
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Matthew T. Tennant, MD, FRCSC

Alberta Retina Consultants
Edmonton, AB Canada
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Michael H. Brent, MD, FRCSC

University Health Network - Toronto Western Hospital
Toronto, ON Canada
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David Maberly, MD MSc FRCSC

UBC/VCHA Eye Care Centre
Vancouver, Canada
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