Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Last updated: May 5, 2025
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Aflibercept

OTX-TKI

Clinical Study ID

NCT06495918
OTX-TKI-2023-AMD-303
  • Ages > 50
  • All Genders

Study Summary

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- RelatedMacular Degeneration (nAMD) with leakage involving the fovea in the study eye priorto Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthlyinjections of 2 mg aflibercept with last injection approximately 4 weeks prior toScreening

  • Have provided written consent

Exclusion

Exclusion Criteria:

  • Monocular subject or Best Corrected Visual Acuity (BCVA) score of <20 ETDRS lettersor 20/400 in fellow eye at Screening

  • Have evidence of a scar, fibrosis, or atrophy of >50% of the total lesion in thestudy eye.

Study Design

Total Participants: 825
Treatment Group(s): 2
Primary Treatment: Aflibercept
Phase: 3
Study Start date:
November 27, 2024
Estimated Completion Date:
January 08, 2027

Connect with a study center

  • Centro Privado de Ojos

    Buenos Aires, C1033AAW
    Argentina

    Active - Recruiting

  • Organización Médica de Investigación (OMI)

    Buenos Aires, 1015
    Argentina

    Active - Recruiting

  • Buenos Aires Macula

    Caba, C1061AAE
    Argentina

    Active - Recruiting

  • Fundacion Zambrano - Cirugia Ocular

    Caba, S
    Argentina

    Active - Recruiting

  • Instituto Oftalmologico de Buenos Aires SA - OFTALMOS

    Caba, C1120AAN
    Argentina

    Active - Recruiting

  • Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares

    Ciudad Autonoma de Buenos Aire, C1023AAQ
    Argentina

    Active - Recruiting

  • Charles Research Center (Centro Oftalmologico Dr. Charles S.A)

    Ciudad Autonoma de Buenos Aires, C1121ABB
    Argentina

    Active - Recruiting

  • Centro Vision S.A.

    Ciudad de Mendoza, M5500
    Argentina

    Active - Recruiting

  • Oftar Mendoza Srl Centro Privado de Oftalmologia

    Mendoza, M5500GGK
    Argentina

    Active - Recruiting

  • Laser Vision Group

    Rosario, S2000
    Argentina

    Active - Recruiting

  • Albury Eye Clinic

    Albury, New South Wales 2640
    Australia

    Active - Recruiting

  • Marsden Eye Specialists (MES) - Parramatta

    Parramatta, New South Wales 2150
    Australia

    Active - Recruiting

  • Emanuelli Research and Development Center, LLC

    Arecibo, 612
    Puerto Rico

    Active - Recruiting

  • Associated Retina Consultant

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retinal Research Institute, LLC

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • The Retina Partners

    Encino, California 91436
    United States

    Active - Recruiting

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Atlantis Eyecare

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Salehi Retina Institute, Inc., dba Retina Associates of Southern California

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Kaiser Permanente Division of Research

    Oakland, California 94611
    United States

    Active - Recruiting

  • California Retina Consultants

    Oxnard, California 93036
    United States

    Active - Recruiting

  • Stanford University School of Medicine, Byers Eye Institute

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • California Eye Specialists Medical Group, INC

    Pasadena, California 91107
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95841
    United States

    Active - Recruiting

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • California Retina Consultants

    Santa Barbara, California 93103
    United States

    Active - Recruiting

  • Macula Retina Vitreous Research Institute

    Torrance, California 90503
    United States

    Active - Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • RSC Research, LLC

    Denver, Colorado 80210
    United States

    Active - Recruiting

  • Colorado Retina Associates

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Retina Consultants, P.C

    Manchester, Connecticut 06042
    United States

    Active - Recruiting

  • Retina Group of New England

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Advanced Research LLC.

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • South Florida Retina Institute

    Miami, Florida 33145
    United States

    Active - Recruiting

  • Florida Retina Institude

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida- Saint Petersburg

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • MedEye Associates

    South Miami, Florida 33143
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida

    Tampa, Florida 33617
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Springfield Clinic Opthalmology Department

    Springfield, Illinois 62703
    United States

    Active - Recruiting

  • Associate Vitreoretinal and Uveitis Consultants

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Retina Partners Midwest, P.C.

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Wolfe Clinic PC dba Wolfe Eye Clinic

    West Des Moines, Iowa 50026
    United States

    Active - Recruiting

  • The Retina Group of Washington - Chevy Chase

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Retina Specialists - Towson Office

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Associated Retinal Consultants, P.C.

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Retina Consultants of Minnesota

    Minneapolis, Minnesota 55435
    United States

    Active - Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Active - Recruiting

  • The Retina Center Of New Jersey, LLC - Bloomfield

    Bloomfield, New Jersey 07003
    United States

    Active - Recruiting

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Asheville Eye Associates (AEA) - Asheville

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Palmetto Retina Center, LLC

    Aiken, South Carolina 29802
    United States

    Active - Recruiting

  • Charleston Neuroscience Instititute, LLC

    Beaufort, South Carolina 29902
    United States

    Active - Recruiting

  • Palmetto Retina Center, LLC

    Florence, South Carolina 29501
    United States

    Active - Recruiting

  • Palmetto Retina Center, LLC

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • Black Hills Regional Eye Institute, LLP

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Southeastern Retina Associates PC

    Johnson City, Tennessee 37604
    United States

    Active - Recruiting

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Beaumont, Texas 77707
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Star Vision Research

    Burleson, Texas 76028
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Texas Retina Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Retina Associates of Utah

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Retina Group of Washington

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Vistar Eye Center

    Roanoke, Virginia 24019
    United States

    Active - Recruiting

  • Eye Clinic of Wisconsin, SC

    Wausau, Wisconsin 54403
    United States

    Active - Recruiting

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