A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Last updated: April 25, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Macular Edema

Diabetic Retinopathy

Geographic Atrophy

Treatment

Aflibercept 8 mg

Clinical Study ID

NCT06491914
VGFTe-HD-OD-2444
  • Ages > 18
  • All Genders

Study Summary

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.

The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Eligibility Criteria

Inclusion

Key Inclusion Criteria for Participants with nAMD:

  1. ≥50 years of age

  2. History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.

Key Inclusion Criteria for Participants with DME:

  1. ≥18 years of age

  2. History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator

Key Inclusion for All Participants:

  1. Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1

Key Exclusion Criteria for Participants with nAMD:

  1. Evidence of CNV due to any cause other than nAMD in either eye

Key Exclusion Criteria for Participants with DME:

  1. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye

  2. Active proliferative diabetic retinopathy (DR) in the study eye

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Study Design

Total Participants: 1118
Treatment Group(s): 1
Primary Treatment: Aflibercept 8 mg
Phase: 3
Study Start date:
July 24, 2024
Estimated Completion Date:
January 07, 2027

Connect with a study center

  • Emanuelli Research and Development Center

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Win Retina

    Arcadia, California 91006
    United States

    Site Not Available

  • Win Retina - Arcadia

    Arcadia, California 91006
    United States

    Site Not Available

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Site Not Available

  • Retina Specialists of Beverly Hills

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Salehi Retina Institute dba Retina Associates of Southern California

    Huntington Beach, California 92647
    United States

    Site Not Available

  • South Coast Retina Center

    Long Beach, California 90807
    United States

    Site Not Available

  • California Eye Specialists Medical Group, Inc.

    Pasadena, California 91107
    United States

    Site Not Available

  • Retina Consultants of Southern California

    Redlands, California 92374
    United States

    Site Not Available

  • VRMG, Inc

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Vrmg Inc

    Sacramento, California 95825
    United States

    Site Not Available

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute

    Longmont, Colorado 80503
    United States

    Site Not Available

  • Retina Group of New England

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • Advanced Research, LLC

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Florida Retina Institute

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Florida Retina Institute - Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Retina Speciality Institute - Pensacola, Florida

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida Saint Petersburg

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Tampa, Florida 33617
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Georgia Retina

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Retina Consultants of Hawaii, Inc.

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • University Retina and Macula Associates PC - Lemont

    Lemont, Illinois 60439
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Springfield Clinic Main Campus East

    Springfield, Illinois 62703
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants-Ophthalmology

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland 21740-5846
    United States

    Active - Recruiting

  • Mid Atlantic Retina Specialists Hagerstown

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Opthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Retina Consultants of Minnesota

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • NJ Retina

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Vitreoretinal Consultants of NY

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Vitreoretinal Consultants of NY - Westbury

    Westbury, New York 11590
    United States

    Site Not Available

  • North Carolina Retina Associates

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Retina Associates of Cleveland - Beachwood

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Tulsa Retina Consultants

    Tulsa, Oklahoma 74114
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Sewickley Eye Group

    Sewickley, Pennsylvania 15143
    United States

    Site Not Available

  • Charleston Neuroscience Institute LLC

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Charleston Neuroscience Institute, LLC

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Consultants of Texas

    Beaumont, Texas 77707
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Retina Consultants of Texas - Houston

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Texas Retina Associates - Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Southwest Retina Consultants

    El Paso, Texas 79902
    United States

    Site Not Available

  • Retina Consultants of Texas

    Katy, Texas 77494
    United States

    Site Not Available

  • Austin Retina Associates

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Consultants of Texas Brown Retina Institute

    San Antonio, Texas 78251
    United States

    Site Not Available

  • San Antonio Eye Center - Downtown Clinic

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Retina Consultants Texas

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Retina Group of Washington

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Pacific Northwest Retina

    Bellevue, Washington 98004
    United States

    Site Not Available

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