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ACTIVE NOT RECRUITING
NCT06223958
PHASE3

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

Sponsor: Ocular Therapeutix, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2024-01-29

Completion Date

2027-09-27

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

DRUG

OTX-TKI (axitinib implant)

Intravitreal Injection of OTX-TKI (axitinib implant)

DRUG

Aflibercept

Injection of 2mg (0.05mL) of aflibercept

Locations (108)

Associated Retina Consultants - Gilbert

Gilbert, Arizona, United States

Associated Retina Consultants - Phoenix

Phoenix, Arizona, United States

Retinal Research Institute

Phoenix, Arizona, United States

Retina Macula Institute of Arizona

Scottsdale, Arizona, United States

CA CRC California Retina Consultants

Bakersfield, California, United States

The Retina Partners - Encino

Encino, California, United States

Retina Consultants of Orange County - Fullerton

Fullerton, California, United States

Atlantis Eyecare

Huntington Beach, California, United States

Lakeside Vision Center - Irvine

Irvine, California, United States

Retina-Vitreous Associates Medical Group - Los Angeles

Los Angeles, California, United States

CA RCMG Retinal Consultants Medical Group, Inc.

Modesto, California, United States

Retina Sacramento MSO, LLC

Modesto, California, United States

Kaiser Permanente Division of Research

Oakland, California, United States

CA CRC California Retina Consultants

Oxnard, California, United States

Stanford University School of Medicine, Byers Eye Institute

Palo Alto, California, United States

Doheny Eye Center

Pasadena, California, United States

AzulVision

Pasadena, California, United States

Orange County Retina Medical Group

Santa Ana, California, United States

California Retina Consultants (CRC) - Santa Barbara

Santa Barbara, California, United States

Macula Retina Vitreous Center

Torrance, California, United States

Bay Area Retina Associates, A Medical Group

Walnut Creek, California, United States

Retina Consultants of Southern Colorado - Colorado Springs

Colorado Springs, Colorado, United States

RSC Research, PLLC

Denver, Colorado, United States

Colorado Retina Associates (CRA) - Lakewood

Lakewood, Colorado, United States

Retina Group of New England, PC

Waterford, Connecticut, United States

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

Clearwater, Florida, United States

Rand Eye Institute

Deerfield Beach, Florida, United States

Speciality Retina Center

Deerfield Beach, Florida, United States

Retina Group of Florida - Fort Lauderdale

Fort Lauderdale, Florida, United States

Florida Retina Institute - Lake Mary

Lake Mary, Florida, United States

Florida Retina Consultants - Lakeland

Lakeland, Florida, United States

South Florida Retina Institute

Miami, Florida, United States

Retina Specialty Institute - Pensacola

Pensacola, Florida, United States

MedEye Associates - Miami

South Miami, Florida, United States

Retina Vitreous Associates of Florida (RVA) - Saint Petersburg

St. Petersburg, Florida, United States

Retina Vitreous Associates of Florida - Tampa

Tampa, Florida, United States

Retina Associates of Florida LLC Tampa MacDill

Tampa, Florida, United States

Southeast Retina Center, P.C. - Augusta

Augusta, Georgia, United States

Illinois Eye and Ear Infirmary at UI Health UIC

Chicago, Illinois, United States

Illinois Retina Associates, S.C. - Lincoln Park

Chicago, Illinois, United States

University Retina and Macula Associates, P.C.

Oak Forest, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

IN AVRUC Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, United States

Retina Partners Midwest

Indianapolis, Indiana, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Maine Eye Center - Marginal Way Campus

Portland, Maine, United States

The Wilmer Eye Institute

Baltimore, Maryland, United States

Mid Atlantic Retina Specialists - Hagerstown

Hagerstown, Maryland, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

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

Royal Oak, Michigan, United States

Retina Consultants of Minnesota

Edina, Minnesota, United States

Mississippi Baptist Medical Center

Jackson, Mississippi, United States

Pepose Vision Institute

Chesterfield, Missouri, United States

Retina Research Institute, LLC

St Louis, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

The Retina Center Of New Jersey, LLC - Bloomfield

Bloomfield, New Jersey, United States

Long Island Vitreoretinal Consultants (VRC) - Hauppauge

Hauppauge, New York, United States

Retina-Vitreous Surgeons of Central New York

Liverpool, New York, United States

NY LIVRC Long Island Vitreoretinal Consultants

Shirley, New York, United States

Asheville Eye Associates (AEA) - Retinal Office

Asheville, North Carolina, United States

Duke University Health System - Duke Eye Center Of North Durham

Durham, North Carolina, United States

Retina Associates of Cleveland, Inc. - Beachwood

Beachwood, Ohio, United States

Retina Associates of Cleveland

Cleveland, Ohio, United States

Retina Associates of Cleveland, Inc. - Youngstown

Youngstown, Ohio, United States

Erie Retina Research

Erie, Pennsylvania, United States

Palmetto Retina Center

Aiken, South Carolina, United States

Charleston Neuroscience Institute LLC - Beaufort

Beaufort, South Carolina, United States

SC CNI Retina Consultants of Charleston

Beaufort, South Carolina, United States

Charleston Neuroscience Institute LLC - Charleston

Charleston, South Carolina, United States

Palmetto Retina Center

Florence, South Carolina, United States

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Retina Consultants of Charleston - Mount Pleasant

Mt. Pleasant, South Carolina, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Black Hills Regional Eye Institute (BHREI)

Rapid City, South Dakota, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Charles Retina Institute PC

Germantown, Tennessee, United States

Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location

Nashville, Tennessee, United States

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

Abilene, Texas, United States

Texas Retina Associates (TRA) - Arlington

Arlington, Texas, United States

Retina Consultants of Austin PA (RCA) - Central Austin

Austin, Texas, United States

Austin Retina Associates, PLLC

Austin, Texas, United States

Keystone Research

Austin, Texas, United States

Retina Research Center (RRC)

Austin, Texas, United States

Retina Consultants of Texas Beaumont

Beaumont, Texas, United States

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

Bellaire, Texas, United States

Star Vision Consultants

Burleson, Texas, United States

Texas Retina Center

Houston, Texas, United States

Retina Consultants of Texas - Katy

Katy, Texas, United States

Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location

San Antonio, Texas, United States

Retinal Consultants of Texas - San Antonio Medical Center

San Antonio, Texas, United States

TX RCTX Retina Consultants of Texas

San Antonio, Texas, United States

Retina Consultants of Houston

The Woodlands, Texas, United States

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

Salt Lake City, Utah, United States

Wagner Macula & Retina Center - Norfolk, VA Office

Norfolk, Virginia, United States

Vistar Eye Center Vision and Surgery Specialists

Roanoke, Virginia, United States

Eye Clinic of Wisconsin

Wausau, Wisconsin, United States

Buenos Aires Macula

Pilar, Buenos Aires, Argentina

Centro Oftalmologico Dr. Charles S.A

Buenos Aires, Buenos Aires F.D., Argentina

Organizacion Medica de Investigacion OMI

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Zambrano - Cirugia Ocular

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Oftalmologico de Alta Complejidad

Buenos Aires, Buenos Aires F.D., Argentina

Oftalmologia Global

Rosario, Santa Fe Province, Argentina

Centro Privado de Ojos Romagosa SA

Córdoba, Argentina

Oftar Mendoza Srl Centro Privado de Oftalmologia

Mendoza, Argentina

Centrovision

Mendoza, Argentina

Laser Vision Group

Santa Fe, Argentina

Emanuelli research and development

Arecibo, Puerto Rico