Phase
Condition
Diabetes And Hypertension
Diabetic Retinopathy
Diabetes Prevention
Treatment
High-dose aflibercept
aflibercept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Diabetic macular edema (DME) with central involvement in the study eye
Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320)in the study eye with decreased vision determined to be primarily the result of DME
Willing and able to comply with clinic visits and study-related procedures
Provide informed consent signed by study participant or legally acceptablerepresentative
Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.
Exclusion
Key Exclusion Criteria:
Evidence of macular edema due to any cause other than diabetes mellitus in eithereye
Active proliferative diabetic retinopathy in the study eye
IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab,pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laserphotocoagulation within 12 weeks (84 days) or intraocular or periocularcorticosteroids within 16 weeks (112 days) of the screening visit in the study eye
Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecificmonoclonal antibodies, gene therapy, etc.) at any time
Treatment with ocriplasmin (JETREA®) in the study eye at any time
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Study Design
Connect with a study center
Regeneron Study Site
Calgary, Alberta T2H 0C8
CanadaSite Not Available
Regeneron Study Site
Mississauga, Ontario L4W 1W9
CanadaSite Not Available
Regeneron Study Site
North York, Ontario M3C 0G9
CanadaSite Not Available
Regeneron Study Site
Sherbrooke, Quebec J1G 2V4
CanadaSite Not Available
Regeneron Study Site
Pardubice, 530 02
CzechiaSite Not Available
Regeneron Study Site
Prague 5, 150 00
CzechiaSite Not Available
Regeneron Study Site
Praha 10, 100 34
CzechiaSite Not Available
Regeneron Study Site
Praha 2, 128 08
CzechiaSite Not Available
Regeneron Study Site
Tubingen, Baden-Wurttemberg 72076
GermanySite Not Available
Regeneron Study Site
Wurzburg, Bayern 97080
GermanySite Not Available
Regeneron Study Site
Marburg, Hessen 35043
GermanySite Not Available
Regeneron Study Site
Greifswald, Mecklenburg-Vorpommern 17475
GermanySite Not Available
Regeneron Study Site
Neubrandenburg, Mecklenburg-Westfalen 17036
GermanySite Not Available
Regeneron Study Site
Dusseldorf, Nordrhein-Westfalen 40225
GermanySite Not Available
Regeneron Study Site
Gottingen, Nordrhein-Westfalen 37075
GermanySite Not Available
Regeneron Study Site
Munster, Nordrhein-Westfalen 48145
GermanySite Not Available
Regeneron Study Site
Dresden, Sachsen 01307
GermanySite Not Available
Regeneron Study Site
Lubeck, Schleswig-Holstein 23538
GermanySite Not Available
Regeneron Study Site
Berlin, 10713
GermanySite Not Available
Regeneron Study Site
Hamburg, 20246
GermanySite Not Available
Regeneron Study Site 1
Pecs, Baranya H-7621
HungarySite Not Available
Regeneron Study Site
Szombathely, Vas H-9700
HungarySite Not Available
Regeneron Study Site
Zalaegerszeg, Zala Megye H-8900
HungarySite Not Available
Regeneron Study Site
Budapest, H-1085
HungarySite Not Available
Regeneron Study Site
Debrecen, H-4032
HungarySite Not Available
Regeneron Study Site
Szeged, H-6720
HungarySite Not Available
Regeneron Study Site
Nagakute, Aichi 480-1195
JapanSite Not Available
Regeneron Study Site
Nagoya, Aichi 466-8560
JapanSite Not Available
Regeneron Study Site
Yoshida-Gun, Fukui 910-1193
JapanSite Not Available
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Kurume, Fukuoka 830-0011
JapanSite Not Available
Regeneron Study Site
Koriyama, Fukushima 963-8052
JapanSite Not Available
Regeneron Study Site
Hakodate, Hokkaido 041-0851
JapanSite Not Available
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Kobe, Hyogo 650-0017
JapanSite Not Available
Regeneron Study Site
Mito, Ibaraki 310-0845
JapanSite Not Available
Regeneron Study Site
Toride, Ibaraki 302-0014
JapanSite Not Available
Regeneron Study Site
Tsuchiura-shi, Ibaraki 300-0817
JapanSite Not Available
Regeneron Study Site
Kita-gun, Kagawa 761-0793
JapanSite Not Available
Regeneron Study Site
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
Regeneron Study Site
Tsu, Mie 514-8507
JapanSite Not Available
Regeneron Study Site
Matsumoto, Nagano 390-8621
JapanSite Not Available
Regeneron Study Site
Nagasaki City, Nagasaki 852-8501
JapanSite Not Available
Regeneron Study Site
Kashihara, Nara 634-8522
JapanSite Not Available
Regeneron Study Site
Yufu, Oita 879-5593
JapanSite Not Available
Regeneron Study Site
Nakagami-gun, Okinawa 903-0215
JapanSite Not Available
Regeneron Study Site
Hirakata, Osaka 573-1191
JapanSite Not Available
Regeneron Study Site
Tokorozawa, Saitama 359-8513
JapanSite Not Available
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Susono, Shizuoka 410-1102
JapanSite Not Available
Regeneron Study Site
Chiyoda-ku, Tokyo 101-8309
JapanSite Not Available
Regeneron Study Site
Hachioji, Tokyo 193-0998
JapanSite Not Available
Regeneron Study Site
Itabashi-ku, Tokyo 173-0015
JapanSite Not Available
Regeneron Study Site
Meguro-ku, Tokyo 152-8902
JapanSite Not Available
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Shimotsuke-shi, Totigi 329-0498
JapanSite Not Available
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Ube, Yamaguchi 755-8505
JapanSite Not Available
Regeneron Study Site
Fukuoka, 819-8585
JapanSite Not Available
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Kagoshima, 890-8520
JapanSite Not Available
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Miyazaki, 889-1692
JapanSite Not Available
Regeneron Study Site
Niigata, 951-8520
JapanSite Not Available
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Osaka, 545-8586
JapanSite Not Available
Regeneron Study Site
Saitama, 330-8553
JapanSite Not Available
Regeneron Study Site
Tokushima, 770-8503
JapanSite Not Available
Regeneron Study Site
Arecibo, 00612
Puerto RicoSite Not Available
Regeneron Study Site
Frimley, Surrey GU16 7UJ
United KingdomSite Not Available
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Sunderland, Tyne And Wear SR2 9HP
United KingdomSite Not Available
Regeneron Study Site
London, EC1V 2PD
United KingdomSite Not Available
Regeneron Study Site
Phoenix, Arizona 85021
United StatesSite Not Available
Regeneron Study Site
Arcadia, California 91006
United StatesSite Not Available
Regeneron Study Site
Beverly Hills, California 90211
United StatesSite Not Available
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Campbell, California 95008
United StatesSite Not Available
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Encino, California 91436
United StatesSite Not Available
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Fullerton, California 92835
United StatesSite Not Available
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Glendale, California 91203
United StatesSite Not Available
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Huntington Beach, California 92647
United StatesSite Not Available
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La Jolla, California 92093
United StatesSite Not Available
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Long Beach, California 90807
United StatesSite Not Available
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Palo Alto, California 94303
United StatesSite Not Available
Regeneron Study Site
Pasadena, California 91107
United StatesSite Not Available
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Poway, California 92064
United StatesSite Not Available
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Rancho Cordova, California 95670
United StatesSite Not Available
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Riverside, California 92505
United StatesSite Not Available
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Torrance, California 90509
United StatesSite Not Available
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Colorado Springs, Colorado 80909
United StatesSite Not Available
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Durango, Colorado 81301
United StatesSite Not Available
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Golden, Colorado 80401
United StatesSite Not Available
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Lakewood, Colorado 80228
United StatesSite Not Available
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Waterford, Connecticut 06385
United StatesSite Not Available
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Boynton Beach, Florida 33426
United StatesSite Not Available
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Clearwater, Florida 33761
United StatesSite Not Available
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Fort Lauderdale, Florida 33308
United StatesSite Not Available
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Fort Myers, Florida 33912
United StatesSite Not Available
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Gainesville, Florida 32607
United StatesSite Not Available
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Jacksonville, Florida 32216
United StatesSite Not Available
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Lakeland, Florida 33805
United StatesSite Not Available
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Largo, Florida 33770
United StatesSite Not Available
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Melbourne, Florida 32901
United StatesSite Not Available
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Miami, Florida 33126
United StatesSite Not Available
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Orlando, Florida 32806
United StatesSite Not Available
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Pinellas Park, Florida 33782
United StatesSite Not Available
Regeneron Study Site
Plantation, Florida 33324
United StatesSite Not Available
Regeneron Study Site
Saint Petersburg, Florida 33711
United StatesSite Not Available
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Stuart, Florida 34994
United StatesSite Not Available
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Tampa, Florida 33612
United StatesSite Not Available
Regeneron Study Site
Winter Haven, Florida 33880
United StatesSite Not Available
Regeneron Study Site
Augusta, Georgia 30909
United StatesSite Not Available
Regeneron Study Site 1
Marietta, Georgia 30060
United StatesSite Not Available
Regeneron Study Site 2
Marietta, Georgia 30060
United StatesSite Not Available
Regeneron Study Site
'Aiea, Hawaii 96701
United StatesSite Not Available
Regeneron Study Site
Oak Forest, Illinois 60452
United StatesSite Not Available
Regeneron Study Site
Springfield, Illinois 62704
United StatesSite Not Available
Regeneron Study Site
Carmel, Indiana 46290
United StatesSite Not Available
Regeneron Study Site
Leawood, Kansas 66211
United StatesSite Not Available
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Shawnee Mission, Kansas 66204
United StatesSite Not Available
Regeneron Study Site
Metairie, Louisiana 70006
United StatesSite Not Available
Regeneron Study Site
Baltimore, Maryland 21209
United StatesSite Not Available
Regeneron Study Site
Hagerstown, Maryland 21740
United StatesSite Not Available
Regeneron Study Site 1
Towson, Maryland 21204
United StatesSite Not Available
Regeneron Study Site
Boston, Massachusetts 02114
United StatesSite Not Available
Regeneron Study Site
Worcester, Massachusetts 01605
United StatesSite Not Available
Regeneron Study Site
Royal Oak, Michigan 48073
United StatesSite Not Available
Regeneron Study Site
Southaven, Mississippi 38671
United StatesSite Not Available
Regeneron Study Site
Chesterfield, Missouri 63017
United StatesSite Not Available
Regeneron Study Site
Henderson, Nevada 89052
United StatesSite Not Available
Regeneron Study Site
Bloomfield, New Jersey 07003
United StatesSite Not Available
Regeneron Study Site
Edison, New Jersey 08820
United StatesSite Not Available
Regeneron Study Site
Teaneck, New Jersey 07666
United StatesSite Not Available
Regeneron Study Site
Albuquerque, New Mexico 87109
United StatesSite Not Available
Regeneron Study Site
Great Neck, New York 11021
United StatesSite Not Available
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Liverpool, New York 13088
United StatesSite Not Available
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New York, New York 11221
United StatesSite Not Available
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Oceanside, New York 11572
United StatesSite Not Available
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Shirley, New York 02114
United StatesSite Not Available
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Troy, New York 12180
United StatesSite Not Available
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Asheville, North Carolina 28803
United StatesSite Not Available
Regeneron Study Site
Charlotte, North Carolina 28210
United StatesSite Not Available
Regeneron Study Site
Beachwood, Ohio 44122
United StatesSite Not Available
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Cincinnati, Ohio 45242
United StatesSite Not Available
Regeneron Study Site
Cleveland, Ohio 44130
United StatesSite Not Available
Regeneron Study Site
Columbus, Ohio 43212
United StatesSite Not Available
Regeneron Study Site
Dublin, Ohio 43016
United StatesSite Not Available
Regeneron Study Site
Edmond, Oklahoma 73013
United StatesSite Not Available
Regeneron Study Site
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Regeneron Study Site
Tulsa, Oklahoma 74114
United StatesSite Not Available
Regeneron Study Site
Portland, Oregon 97225
United StatesSite Not Available
Regeneron Study Site
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
Regeneron Study Site
Kingston, Pennsylvania 18704
United StatesSite Not Available
Regeneron Study Site
Monroeville, Pennsylvania 15146
United StatesSite Not Available
Regeneron Study Site
Beaufort, South Carolina 29902
United StatesSite Not Available
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Ladson, South Carolina 29456
United StatesSite Not Available
Regeneron Study Site
West Columbia, South Carolina 29169
United StatesSite Not Available
Regeneron Study Site
Rapid City, South Dakota 57701
United StatesSite Not Available
Regeneron Study Site
Chattanooga, Tennessee 37421
United StatesSite Not Available
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Germantown, Tennessee 38138
United StatesSite Not Available
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Knoxville, Tennessee 37922
United StatesSite Not Available
Regeneron Study Site
Nashville, Tennessee 37203
United StatesSite Not Available
Regeneron Study Site
Abilene, Texas 79606
United StatesSite Not Available
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Arlington, Texas 76012
United StatesSite Not Available
Regeneron Study Site
Austin, Texas 78705
United StatesSite Not Available
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Bellaire, Texas 77401
United StatesSite Not Available
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Houston, Texas 77030
United StatesSite Not Available
Regeneron Study Site
McAllen, Texas 78503
United StatesSite Not Available
Regeneron Study Site 2
San Antonio, Texas 78240
United StatesSite Not Available
Regeneron Study Site
The Woodlands, Texas 77384
United StatesSite Not Available
Regeneron Study Site
Willow Park, Texas 76087
United StatesSite Not Available
Regeneron Study Site 1
Salt Lake City, Utah 84107
United StatesSite Not Available
Regeneron Study Site
Charlottesville, Virginia 22903
United StatesSite Not Available
Regeneron Study Site
Fairfax, Virginia 22031
United StatesSite Not Available
Regeneron Study Site
Norfolk, Virginia 23502
United StatesSite Not Available
Regeneron Study Site
Morgantown, West Virginia 26506
United StatesSite Not Available
Regeneron Study Site
Madison, Wisconsin 53705
United StatesSite Not Available
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