Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

Last updated: July 15, 2020
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Diabetic Retinopathy

Retina

Treatment

N/A

Clinical Study ID

NCT02718326
VGFTe-OD-1411
2016-002639-14
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).

The secondary objectives of the study are:

  • To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR

  • To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME

  • To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderatelysevere to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathyseverity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, inwhom panretinal photocoagulation (PRP) can be safely deferred for at least 6 monthsper the investigator

  2. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS)letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40or better)

Exclusion

Key Exclusion Criteria:

  1. Presence of diabetic macular edema (DME) threatening the center of the macula in thestudy eye

  2. Evidence of retinal neovascularization on clinical examination or FluoresceinAngiography (FA)

  3. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye

  4. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment orintravitreal (IVT) anti-VEGF treatment in the study eye

  5. Any prior intraocular steroid injection in the study eye

  6. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractionalretinal detachment visible at the screening assessments in the study eye Note: Other inclusion/ exclusion criteria apply

Study Design

Total Participants: 402
Study Start date:
March 29, 2016
Estimated Completion Date:
July 16, 2019

Connect with a study center

  • Regeneron Study Site

    Marburg, Hesse 35043
    Germany

    Site Not Available

  • Regeneron Study Site

    Münster, North Rhine-Westphalia 48145
    Germany

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  • Regeneron Study Site

    Leipzig, Saxony 04103
    Germany

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  • Regeneron Study Site

    Szeged, Csongrad 6720
    Hungary

    Site Not Available

  • Regeneron Study Site

    Debrecen, Hajdu-Bihar 4032
    Hungary

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  • Regeneron Study Site

    Budapest, Pest 1106
    Hungary

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  • Regeneron Study Site

    Zalaegerszeg, Zala 8900
    Hungary

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  • Regeneron Study Site

    Asahikawa, Hokkaido 078-8510
    Japan

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  • Regeneron Study Site

    Amagasaki, Hyogo 660-8550
    Japan

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  • Regeneron Study Site

    Matsumoto, Nagano 390-8621
    Japan

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    Chiyoda, Tokyo 101-8309
    Japan

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    Kagoshima, 890-8520
    Japan

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    Nagasaki, 852-8501
    Japan

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    Tokyo,
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    Arecibo, 00613
    Puerto Rico

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    San Juan, 00907
    Puerto Rico

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    Camberley, Surrey GU16 7UJ
    United Kingdom

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    Frimley, Surrey
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    London, EC1V 2PD
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    Phoenix, Arizona 85020
    United States

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    Tucson, Arizona 85704
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    Arcadia, California 91007
    United States

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    Beverly Hills, California 90211
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    Encino, California 91436
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    Fullerton, California 92835
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    Irvine, California
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    La Jolla, California 92093
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    Mountain View, California 94040
    United States

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    Oakland, California 94609
    United States

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    Oceanside, California 92056
    United States

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    Palm Desert, California
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    Poway, California
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    Sacramento, California 95841
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    San Diego, California
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    San Francisco, California
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    Colorado Springs, Colorado 80909
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    Golden, Colorado 80401
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    New London, Connecticut 06320
    United States

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    Altamonte Springs, Florida 32701
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    Bradenton, Florida
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    Deerfield Beach, Florida 33064
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    Fort Lauderdale, Florida
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    Fort Myers, Florida 33912
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    Jacksonville, Florida
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    Lakeland, Florida 33805
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    Largo, Florida 33770
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    Melbourne, Florida 32901
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    Miami, Florida 33143
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    Orlando, Florida 32806
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    Pensacola, Florida
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    Plantation, Florida 33324
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    Tallahassee, Florida 32308
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    Tampa, Florida 33612
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    Winter Haven, Florida 33880
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    Augusta, Georgia
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    Decatur, Georgia
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    Marietta, Georgia 30060
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    Tucker, Georgia 30084
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    Chicago, Illinois 60612
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    Oak Forest, Illinois 60452
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    Indianapolis, Indiana 46290
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    New Albany, Indiana 47150
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    Wichita, Kansas
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    Lexington, Kentucky 40509
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    Portland, Maine
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    Baltimore, Maryland 21209
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    Baltimore, Maryland 21287
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    Hagerstown, Maryland 21740
    United States

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    Boston, Massachusetts 02114
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    Jackson, Michigan
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    Florissant, Missouri
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    Henderson, Nevada 89052
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    Las Vegas, Nevada
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    Portsmouth, New Hampshire
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    Bloomfield, New Jersey 07003
    United States

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    New Brunswick, New Jersey
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    Teaneck, New Jersey
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    Albuquerque, New Mexico 87109
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    East Setauket, New York
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    Great Neck, New York
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    New York, New York
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    Rochester, New York
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    Asheville, North Carolina 28803
    United States

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    Charlotte, North Carolina 28210
    United States

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    Winston Salem, North Carolina
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    Winston-Salem, North Carolina
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    Cincinnati, Ohio
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    Cleveland, Ohio
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    Columbus, Ohio 43212
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    Oklahoma City, Oklahoma 73104
    United States

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    Medford, Oregon 97504
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    Kingston, Pennsylvania 18704
    United States

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    Monroeville, Pennsylvania
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    Philadelphia, Pennsylvania 19107
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    Florence, South Carolina 29501
    United States

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    Ladson, South Carolina 29456
    United States

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    West Columbia, South Carolina 29169
    United States

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    Rapid City, South Dakota 57701
    United States

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    Chattanooga, Tennessee 37421
    United States

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    Germantown, Tennessee 38138
    United States

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    Knoxville, Tennessee
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    Memphis, Tennessee
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    Nashville, Tennessee 37232
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    Abilene, Texas 79606
    United States

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  • Regeneron Study Site 1

    Austin, Texas 78705
    United States

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  • Regeneron Study Site 2

    Austin, Texas 78705
    United States

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    Dallas, Texas 75231
    United States

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    Fort Worth, Texas
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    Harligen, Texas
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    Harlingen, Texas 78559
    United States

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    Houston, Texas 77030
    United States

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    McAllen, Texas
    United States

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    San Antonio, Texas 78240
    United States

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    The Woodlands, Texas 77384
    United States

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  • Regeneron Study Site

    Willow Park, Texas 76087
    United States

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  • Regeneron Study Site

    Salt Lake City, Utah 84132
    United States

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  • Regeneron Study Site

    Burlington, Vermont 05401
    United States

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  • Regeneron Study Site

    Fairfax, Virginia 22031
    United States

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  • Regeneron Study Site

    Spokane, Washington 99204
    United States

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  • Regeneron Study Site

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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