Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

Last updated: July 22, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

2/3

Condition

Diabetes And Hypertension

Diabetic Retinopathy

Diabetes Prevention

Treatment

High-dose aflibercept

aflibercept

Clinical Study ID

NCT04429503
VGFTe-HD-DME-1934
2019-003643-30
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

  • To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response

  • To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

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

Total Participants: 660
Treatment Group(s): 2
Primary Treatment: High-dose aflibercept
Phase: 2/3
Study Start date:
June 29, 2020
Estimated Completion Date:
June 18, 2024

Connect with a study center

  • Regeneron Study Site

    Calgary, Alberta T2H 0C8
    Canada

    Site Not Available

  • Regeneron Study Site

    Mississauga, Ontario L4W 1W9
    Canada

    Site Not Available

  • Regeneron Study Site

    North York, Ontario M3C 0G9
    Canada

    Site Not Available

  • Regeneron Study Site

    Sherbrooke, Quebec J1G 2V4
    Canada

    Site Not Available

  • Regeneron Study Site

    Pardubice, 530 02
    Czechia

    Site Not Available

  • Regeneron Study Site

    Prague 5, 150 00
    Czechia

    Site Not Available

  • Regeneron Study Site

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Regeneron Study Site

    Praha 2, 128 08
    Czechia

    Site Not Available

  • Regeneron Study Site

    Tubingen, Baden-Wurttemberg 72076
    Germany

    Site Not Available

  • Regeneron Study Site

    Wurzburg, Bayern 97080
    Germany

    Site Not Available

  • Regeneron Study Site

    Marburg, Hessen 35043
    Germany

    Site Not Available

  • Regeneron Study Site

    Greifswald, Mecklenburg-Vorpommern 17475
    Germany

    Site Not Available

  • Regeneron Study Site

    Neubrandenburg, Mecklenburg-Westfalen 17036
    Germany

    Site Not Available

  • Regeneron Study Site

    Dusseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • Regeneron Study Site

    Gottingen, Nordrhein-Westfalen 37075
    Germany

    Site Not Available

  • Regeneron Study Site

    Munster, Nordrhein-Westfalen 48145
    Germany

    Site Not Available

  • Regeneron Study Site

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Regeneron Study Site

    Lubeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Regeneron Study Site

    Berlin, 10713
    Germany

    Site Not Available

  • Regeneron Study Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Regeneron Study Site 1

    Pecs, Baranya H-7621
    Hungary

    Site Not Available

  • Regeneron Study Site

    Szombathely, Vas H-9700
    Hungary

    Site Not Available

  • Regeneron Study Site

    Zalaegerszeg, Zala Megye H-8900
    Hungary

    Site Not Available

  • Regeneron Study Site

    Budapest, H-1085
    Hungary

    Site Not Available

  • Regeneron Study Site

    Debrecen, H-4032
    Hungary

    Site Not Available

  • Regeneron Study Site

    Szeged, H-6720
    Hungary

    Site Not Available

  • Regeneron Study Site

    Nagakute, Aichi 480-1195
    Japan

    Site Not Available

  • Regeneron Study Site

    Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • Regeneron Study Site

    Yoshida-Gun, Fukui 910-1193
    Japan

    Site Not Available

  • Regeneron Study Site

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • Regeneron Study Site

    Koriyama, Fukushima 963-8052
    Japan

    Site Not Available

  • Regeneron Study Site

    Hakodate, Hokkaido 041-0851
    Japan

    Site Not Available

  • Regeneron Study Site

    Kobe, Hyogo 650-0017
    Japan

    Site Not Available

  • Regeneron Study Site

    Mito, Ibaraki 310-0845
    Japan

    Site Not Available

  • Regeneron Study Site

    Toride, Ibaraki 302-0014
    Japan

    Site Not Available

  • Regeneron Study Site

    Tsuchiura-shi, Ibaraki 300-0817
    Japan

    Site Not Available

  • Regeneron Study Site

    Kita-gun, Kagawa 761-0793
    Japan

    Site Not Available

  • Regeneron Study Site

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • Regeneron Study Site

    Tsu, Mie 514-8507
    Japan

    Site Not Available

  • Regeneron Study Site

    Matsumoto, Nagano 390-8621
    Japan

    Site Not Available

  • Regeneron Study Site

    Nagasaki City, Nagasaki 852-8501
    Japan

    Site Not Available

  • Regeneron Study Site

    Kashihara, Nara 634-8522
    Japan

    Site Not Available

  • Regeneron Study Site

    Yufu, Oita 879-5593
    Japan

    Site Not Available

  • Regeneron Study Site

    Nakagami-gun, Okinawa 903-0215
    Japan

    Site Not Available

  • Regeneron Study Site

    Hirakata, Osaka 573-1191
    Japan

    Site Not Available

  • Regeneron Study Site

    Tokorozawa, Saitama 359-8513
    Japan

    Site Not Available

  • Regeneron Study Site

    Susono, Shizuoka 410-1102
    Japan

    Site Not Available

  • Regeneron Study Site

    Chiyoda-ku, Tokyo 101-8309
    Japan

    Site Not Available

  • Regeneron Study Site

    Hachioji, Tokyo 193-0998
    Japan

    Site Not Available

  • Regeneron Study Site

    Itabashi-ku, Tokyo 173-0015
    Japan

    Site Not Available

  • Regeneron Study Site

    Meguro-ku, Tokyo 152-8902
    Japan

    Site Not Available

  • Regeneron Study Site

    Shimotsuke-shi, Totigi 329-0498
    Japan

    Site Not Available

  • Regeneron Study Site

    Ube, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Regeneron Study Site

    Fukuoka, 819-8585
    Japan

    Site Not Available

  • Regeneron Study Site

    Kagoshima, 890-8520
    Japan

    Site Not Available

  • Regeneron Study Site

    Miyazaki, 889-1692
    Japan

    Site Not Available

  • Regeneron Study Site

    Niigata, 951-8520
    Japan

    Site Not Available

  • Regeneron Study Site

    Osaka, 545-8586
    Japan

    Site Not Available

  • Regeneron Study Site

    Saitama, 330-8553
    Japan

    Site Not Available

  • Regeneron Study Site

    Tokushima, 770-8503
    Japan

    Site Not Available

  • Regeneron Study Site

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Regeneron Study Site

    Frimley, Surrey GU16 7UJ
    United Kingdom

    Site Not Available

  • Regeneron Study Site

    Sunderland, Tyne And Wear SR2 9HP
    United Kingdom

    Site Not Available

  • Regeneron Study Site

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Regeneron Study Site

    Phoenix, Arizona 85021
    United States

    Site Not Available

  • Regeneron Study Site

    Arcadia, California 91006
    United States

    Site Not Available

  • Regeneron Study Site

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Regeneron Study Site

    Campbell, California 95008
    United States

    Site Not Available

  • Regeneron Study Site

    Encino, California 91436
    United States

    Site Not Available

  • Regeneron Study Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Regeneron Study Site

    Glendale, California 91203
    United States

    Site Not Available

  • Regeneron Study Site

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Regeneron Study Site

    La Jolla, California 92093
    United States

    Site Not Available

  • Regeneron Study Site

    Long Beach, California 90807
    United States

    Site Not Available

  • Regeneron Study Site

    Palo Alto, California 94303
    United States

    Site Not Available

  • Regeneron Study Site

    Pasadena, California 91107
    United States

    Site Not Available

  • Regeneron Study Site

    Poway, California 92064
    United States

    Site Not Available

  • Regeneron Study Site

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Regeneron Study Site

    Riverside, California 92505
    United States

    Site Not Available

  • Regeneron Study Site

    Torrance, California 90509
    United States

    Site Not Available

  • Regeneron Study Site

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Regeneron Study Site

    Durango, Colorado 81301
    United States

    Site Not Available

  • Regeneron Study Site

    Golden, Colorado 80401
    United States

    Site Not Available

  • Regeneron Study Site

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Regeneron Study Site

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • Regeneron Study Site

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Regeneron Study Site

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Regeneron Study Site

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Regeneron Study Site

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Regeneron Study Site

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Regeneron Study Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Regeneron Study Site

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Regeneron Study Site

    Largo, Florida 33770
    United States

    Site Not Available

  • Regeneron Study Site

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Regeneron Study Site

    Miami, Florida 33126
    United States

    Site Not Available

  • Regeneron Study Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Regeneron Study Site

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Regeneron Study Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Regeneron Study Site

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Regeneron Study Site

    Stuart, Florida 34994
    United States

    Site Not Available

  • Regeneron Study Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Regeneron Study Site

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Regeneron Study Site

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Regeneron Study Site 1

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Regeneron Study Site 2

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Regeneron Study Site

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Regeneron Study Site

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Regeneron Study Site

    Springfield, Illinois 62704
    United States

    Site Not Available

  • Regeneron Study Site

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Regeneron Study Site

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Regeneron Study Site

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Regeneron Study Site

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Regeneron Study Site

    Baltimore, Maryland 21209
    United States

    Site Not Available

  • Regeneron Study Site

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Regeneron Study Site 1

    Towson, Maryland 21204
    United States

    Site Not Available

  • Regeneron Study Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Regeneron Study Site

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Regeneron Study Site

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Regeneron Study Site

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • Regeneron Study Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Regeneron Study Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Regeneron Study Site

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Regeneron Study Site

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Regeneron Study Site

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Regeneron Study Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Regeneron Study Site

    Great Neck, New York 11021
    United States

    Site Not Available

  • Regeneron Study Site

    Liverpool, New York 13088
    United States

    Site Not Available

  • Regeneron Study Site

    New York, New York 11221
    United States

    Site Not Available

  • Regeneron Study Site

    Oceanside, New York 11572
    United States

    Site Not Available

  • Regeneron Study Site

    Shirley, New York 02114
    United States

    Site Not Available

  • Regeneron Study Site

    Troy, New York 12180
    United States

    Site Not Available

  • Regeneron Study Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Regeneron Study Site

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Regeneron Study Site

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Regeneron Study Site

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Regeneron Study Site

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Regeneron Study Site

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Regeneron Study Site

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Regeneron Study Site

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Regeneron Study Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Regeneron Study Site

    Tulsa, Oklahoma 74114
    United States

    Site Not Available

  • Regeneron Study Site

    Portland, Oregon 97225
    United States

    Site Not Available

  • Regeneron Study Site

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Regeneron Study Site

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Regeneron Study Site

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • Regeneron Study Site

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • Regeneron Study Site

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Regeneron Study Site

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Regeneron Study Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Regeneron Study Site

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Regeneron Study Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Regeneron Study Site

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Regeneron Study Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Regeneron Study Site

    Abilene, Texas 79606
    United States

    Site Not Available

  • Regeneron Study Site

    Arlington, Texas 76012
    United States

    Site Not Available

  • Regeneron Study Site

    Austin, Texas 78705
    United States

    Site Not Available

  • Regeneron Study Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Regeneron Study Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Regeneron Study Site

    McAllen, Texas 78503
    United States

    Site Not Available

  • Regeneron Study Site 2

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Regeneron Study Site

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Regeneron Study Site

    Willow Park, Texas 76087
    United States

    Site Not Available

  • Regeneron Study Site 1

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Regeneron Study Site

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Regeneron Study Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Regeneron Study Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Regeneron Study Site

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Regeneron Study Site

    Madison, Wisconsin 53705
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.