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

Last updated: April 15, 2025
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Aflibercept

OTX-TKI (axitinib implant)

Clinical Study ID

NCT06223958
OTX-TKI-2023-AMD-301
SOL-1
  • 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 for Neovascular Age-Related Macular Degeneration (nAMD) in eithereye at screening.

  • Are at least older than 50 years of age at Day 1.

  • Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment DiabeticRetinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA

Exclusion

Exclusion Criteria:

  • Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 infellow eye at screening.

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

Study Design

Total Participants: 344
Treatment Group(s): 2
Primary Treatment: Aflibercept
Phase: 3
Study Start date:
January 29, 2024
Estimated Completion Date:
September 27, 2027

Connect with a study center

  • Buenos Aires Macula

    Pilar, Buenos Aires B1629AHJ
    Argentina

    Site Not Available

  • Centro Oftalmologico Dr. Charles S.A

    Buenos Aires, Caba 1121
    Argentina

    Site Not Available

  • Fundacion Zambrano - Cirugia Ocular

    Buenos Aires, Caba C1023AAQ
    Argentina

    Site Not Available

  • Instituto Oftalmologico de Alta Complejidad

    Buenos Aires, Caba C1120AAN
    Argentina

    Site Not Available

  • Organizacion Medica de Investigacion OMI

    Buenos Aires, Caba C1015
    Argentina

    Site Not Available

  • Oftalmologia Global

    Rosario, Santa Fe S2000
    Argentina

    Site Not Available

  • Centro Privado de Ojos Romagosa SA

    Cordoba, X5000AAI
    Argentina

    Site Not Available

  • Centrovision

    Mendoza, M5500
    Argentina

    Site Not Available

  • Oftar Mendoza Srl Centro Privado de Oftalmologia

    Mendoza, M5500GGK
    Argentina

    Site Not Available

  • Laser Vision Group

    Santa Fe, S2126DTO
    Argentina

    Site Not Available

  • Emanuelli research and development

    Arecibo, 612
    Puerto Rico

    Site Not Available

  • Associated Retina Consultants - Gilbert

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Retinal Research Institute

    Pheonix, Arizona 85053
    United States

    Site Not Available

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Retinal Research Institute

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • CA CRC California Retina Consultants

    Bakersfield, California 93103
    United States

    Site Not Available

  • The Retina Partners - Encino

    Encino, California 91436
    United States

    Site Not Available

  • Retina Consultants of Orange County - Fullerton

    Fullerton, California 92835
    United States

    Site Not Available

  • Atlantis Eyecare

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Lakeside Vision Center - Irvine

    Irvine, California 92604
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group - Los Angeles

    Los Angeles, California 90017-4886
    United States

    Site Not Available

  • CA RCMG Retinal Consultants Medical Group, Inc.

    Modesto, California 95356
    United States

    Site Not Available

  • Retina Sacramento MSO, LLC

    Modesto, California 95356
    United States

    Site Not Available

  • Kaiser Permanente Division of Research

    Oakland, California 94611
    United States

    Site Not Available

  • CA CRC California Retina Consultants

    Oxnard, California 93103
    United States

    Site Not Available

  • Stanford University School of Medicine, Byers Eye Institute

    Palo Alto, California 94303
    United States

    Site Not Available

  • AzulVision

    Pasadena, California 91107
    United States

    Site Not Available

  • Doheny Eye Center

    Pasadena, California 91105
    United States

    Site Not Available

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • CA CRC California Retina Consultants

    Santa Barbara, California 93103
    United States

    Active - Recruiting

  • California Retina Consultants (CRC) - Santa Barbara

    Santa Barbara, California 93103-4211
    United States

    Site Not Available

  • Macula Retina Vitreous Center

    Torrance, California 90505
    United States

    Site Not Available

  • Bay Area Retina Associates, A Medical Group

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Retina Consultants of Southern Colorado - Colorado Springs

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • RSC Research, PLLC

    Denver, Colorado 80210
    United States

    Site Not Available

  • Colorado Retina Associates (CRA) - Lakewood

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Retina Group of New England, PC

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Speciality Retina Center

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Retina Group of Florida - Fort Lauderdale

    Fort Lauderdale, Florida 33308-1909
    United States

    Site Not Available

  • Florida Retina Institute - Lake Mary

    Lake Mary, Florida 32746-2175
    United States

    Site Not Available

  • Florida Retina Consultants - Lakeland

    Lakeland, Florida 33805
    United States

    Site Not Available

  • South Florida Retina Institute

    Miami, Florida 33145
    United States

    Site Not Available

  • Retina Specialty Institute - Pensacola

    Pensacola, Florida 32503-2030
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida (RVA) - Saint Petersburg

    Saint Petersburg, Florida 33711-1141
    United States

    Site Not Available

  • MedEye Associates - Miami

    South Miami, Florida 33143
    United States

    Site Not Available

  • Retina Associates of Florida LLC Tampa MacDill

    Tampa, Florida 33609
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida - Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • Southeast Retina Center, P.C. - Augusta

    Augusta, Georgia 30909-6440
    United States

    Site Not Available

  • Illinois Eye and Ear Infirmary at UI Health UIC

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Illinois Retina Associates, S.C. - Lincoln Park

    Chicago, Illinois 60657-7227
    United States

    Site Not Available

  • University Retina and Macula Associates, P.C.

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois 62703
    United States

    Site Not Available

  • IN AVRUC Associated Vitreoretinal and Uveitis Consultants

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Retina Partners Midwest

    Indianapolis, Indiana 46290-1166
    United States

    Site Not Available

  • Wolfe Eye Clinic

    West Des Moines, Iowa 50266-7705
    United States

    Site Not Available

  • Maine Eye Center - Marginal Way Campus

    Portland, Maine 04101-2438
    United States

    Site Not Available

  • The Wilmer Eye Institute

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland 21740-5846
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Associated Retinal Consultants P.C. (ARC) - Royal Oak

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Retina Consultants of Minnesota

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Mississippi Baptist Medical Center

    Jackson, Mississippi 39202-2064
    United States

    Site Not Available

  • Pepose Vision Institute

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Retina Research Institute, LLC

    Saint Louis, Missouri 63144-1317
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502-1605
    United States

    Site Not Available

  • The Retina Center Of New Jersey, LLC - Bloomfield

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Long Island Vitreoretinal Consultants (VRC) - Hauppauge

    Hauppauge, New York 11788
    United States

    Site Not Available

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York 13088
    United States

    Site Not Available

  • NY LIVRC Long Island Vitreoretinal Consultants

    Shirley, New York 11967
    United States

    Site Not Available

  • Asheville Eye Associates (AEA) - Retinal Office

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Duke University Health System - Duke Eye Center Of North Durham

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Retina Associates of Cleveland, Inc. - Beachwood

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Retina Associates of Cleveland

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Retina Associates of Cleveland, Inc. - Youngstown

    Youngstown, Ohio 44505
    United States

    Site Not Available

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Palmetto Retina Center

    Aiken, South Carolina 29802
    United States

    Site Not Available

  • Charleston Neuroscience Institute LLC - Beaufort

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • SC CNI Retina Consultants of Charleston

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • Charleston Neuroscience Institute LLC - Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Palmetto Retina Center

    Florence, South Carolina 29501
    United States

    Site Not Available

  • Charleston Neuroscience Institute

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Retina Consultants of Charleston - Mount Pleasant

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169-2429
    United States

    Site Not Available

  • Black Hills Regional Eye Institute (BHREI)

    Rapid City, South Dakota 57701-7374
    United States

    Site Not Available

  • Vance Thompson Vision

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Charles Retina Institute PC

    Germantown, Tennessee 38138-2405
    United States

    Site Not Available

  • Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location

    Nashville, Tennessee 37203-1596
    United States

    Site Not Available

  • West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA)

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Retina Associates (TRA) - Arlington

    Arlington, Texas 76012-2505
    United States

    Site Not Available

  • Austin Retina Associates, PLLC

    Austin, Texas 78705-1169
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Retina Consultants of Austin PA (RCA) - Central Austin

    Austin, Texas 78705-1023
    United States

    Site Not Available

  • Retina Research Center (RRC)

    Austin, Texas 78750-2302
    United States

    Site Not Available

  • Retina Consultants of Texas Beaumont

    Beaumont, Texas 77707
    United States

    Site Not Available

  • Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Star Vision Consultants

    Burleson, Texas 76028
    United States

    Site Not Available

  • Texas Retina Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Retina Consultants of Texas - Katy

    Katy, Texas 77494
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location

    San Antonio, Texas 78240-1502
    United States

    Site Not Available

  • Retinal Consultants of Texas - San Antonio Medical Center

    San Antonio, Texas 78240
    United States

    Site Not Available

  • TX RCTX Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Consultants of Houston

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Retina Associates of Utah, P.C - Intermountain Medical Center Location

    Salt Lake City, Utah 84107-6767
    United States

    Site Not Available

  • Wagner Macula & Retina Center - Norfolk, VA Office

    Norfolk, Virginia 23502-3933
    United States

    Site Not Available

  • Vistar Eye Center Vision and Surgery Specialists

    Roanoke, Virginia 24019
    United States

    Site Not Available

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin 54403
    United States

    Site Not Available

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