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

NCT06223958 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: OTX-TKI-2023-AMD-301SOL-1
• Study Type: interventional
• Target: 344
• Locations: 3 countries
• Sites: 108

Brief Summary

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

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration; Tyrosine Kinase Inhibitor; OTX-TKI

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity (BCVA)

  Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss

  Up to 36 Weeks

Other Outcomes (1)

• Incidence and severity of treatment emergent adverse events (AEs)

  Up to 104 Weeks

Study Arms (2)

OTX-TKI (axitinib implant)

EXPERIMENTAL

Drug: OTX-TKI (axitinib implant)

Control

OTHER

Drug: Aflibercept

Interventions

OTX-TKI (axitinib implant) DRUG

Intravitreal Injection of OTX-TKI (axitinib implant)

OTX-TKI (axitinib implant)

Aflibercept DRUG

Injection of 2mg (0.05mL) of aflibercept

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye 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 Diabetic Retinopathy 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

You may not qualify if:

• Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening.
• Have evidence of a scar, fibrosis, or atrophy of \> 50% of the total lesion in the study eye.

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead
• Fortrea: collaborator
• Duke University: collaborator

Study Sites (108)

Associated Retina Consultants - Gilbert

Gilbert, Arizona, 85297, United States

Location

Associated Retina Consultants - Phoenix

Phoenix, Arizona, 85020, United States

Location

Retinal Research Institute

Phoenix, Arizona, 85053, United States

Location

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

CA CRC California Retina Consultants

Bakersfield, California, 93103, United States

Location

The Retina Partners - Encino

Encino, California, 91436, United States

Location

Retina Consultants of Orange County - Fullerton

Fullerton, California, 92835, United States

Location

Atlantis Eyecare

Huntington Beach, California, 92647, United States

Location

Lakeside Vision Center - Irvine

Irvine, California, 92604, United States

Location

Retina-Vitreous Associates Medical Group - Los Angeles

Los Angeles, California, 90017-4886, United States

Location

CA RCMG Retinal Consultants Medical Group, Inc.

Modesto, California, 95356, United States

Location

Retina Sacramento MSO, LLC

Modesto, California, 95356, United States

Location

Kaiser Permanente Division of Research

Oakland, California, 94611, United States

Location

CA CRC California Retina Consultants

Oxnard, California, 93103, United States

Location

Stanford University School of Medicine, Byers Eye Institute

Palo Alto, California, 94303, United States

Location

Doheny Eye Center

Pasadena, California, 91105, United States

Location

AzulVision

Pasadena, California, 91107, United States

Location

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

California Retina Consultants (CRC) - Santa Barbara

Santa Barbara, California, 93103-4211, United States

Location

Macula Retina Vitreous Center

Torrance, California, 90505, United States

Location

Bay Area Retina Associates, A Medical Group

Walnut Creek, California, 94598, United States

Location

Retina Consultants of Southern Colorado - Colorado Springs

Colorado Springs, Colorado, 80909, United States

Location

RSC Research, PLLC

Denver, Colorado, 80210, United States

Location

Colorado Retina Associates (CRA) - Lakewood

Lakewood, Colorado, 80228, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

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

Clearwater, Florida, 33761, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Speciality Retina Center

Deerfield Beach, Florida, 33064, United States

Location

Retina Group of Florida - Fort Lauderdale

Fort Lauderdale, Florida, 33308-1909, United States

Location

Florida Retina Institute - Lake Mary

Lake Mary, Florida, 32746-2175, United States

Location

Florida Retina Consultants - Lakeland

Lakeland, Florida, 33805, United States

Location

South Florida Retina Institute

Miami, Florida, 33145, United States

Location

Retina Specialty Institute - Pensacola

Pensacola, Florida, 32503-2030, United States

Location

MedEye Associates - Miami

South Miami, Florida, 33143, United States

Location

Retina Vitreous Associates of Florida (RVA) - Saint Petersburg

St. Petersburg, Florida, 33711-1141, United States

Location

Retina Vitreous Associates of Florida - Tampa

Tampa, Florida, 33607, United States

Location

Retina Associates of Florida LLC Tampa MacDill

Tampa, Florida, 33609, United States

Location

Southeast Retina Center, P.C. - Augusta

Augusta, Georgia, 30909-6440, United States

Location

Illinois Eye and Ear Infirmary at UI Health UIC

Chicago, Illinois, 60612, United States

Location

Illinois Retina Associates, S.C. - Lincoln Park

Chicago, Illinois, 60657-7227, United States

Location

University Retina and Macula Associates, P.C.

Oak Forest, Illinois, 60452, United States

Location

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

IN AVRUC Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, 46290, United States

Location

Retina Partners Midwest

Indianapolis, Indiana, 46290-1166, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266-7705, United States

Location

Maine Eye Center - Marginal Way Campus

Portland, Maine, 04101-2438, United States

Location

The Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Mid Atlantic Retina Specialists - Hagerstown

Hagerstown, Maryland, 21740-5846, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

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

Royal Oak, Michigan, 48073, United States

Location

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

Location

Mississippi Baptist Medical Center

Jackson, Mississippi, 39202-2064, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Retina Research Institute, LLC

St Louis, Missouri, 63144-1317, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502-1605, United States

Location

The Retina Center Of New Jersey, LLC - Bloomfield

Bloomfield, New Jersey, 07003, United States

Location

Long Island Vitreoretinal Consultants (VRC) - Hauppauge

Hauppauge, New York, 11788, United States

Location

Retina-Vitreous Surgeons of Central New York

Liverpool, New York, 13088, United States

Location

NY LIVRC Long Island Vitreoretinal Consultants

Shirley, New York, 11967, United States

Location

Asheville Eye Associates (AEA) - Retinal Office

Asheville, North Carolina, 28803, United States

Location

Duke University Health System - Duke Eye Center Of North Durham

Durham, North Carolina, 27705, United States

Location

Retina Associates of Cleveland, Inc. - Beachwood

Beachwood, Ohio, 44122, United States

Location

Retina Associates of Cleveland

Cleveland, Ohio, 44130, United States

Location

Retina Associates of Cleveland, Inc. - Youngstown

Youngstown, Ohio, 44505, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Palmetto Retina Center

Aiken, South Carolina, 29802, United States

Location

Charleston Neuroscience Institute LLC - Beaufort

Beaufort, South Carolina, 29902, United States

Location

SC CNI Retina Consultants of Charleston

Beaufort, South Carolina, 29902, United States

Location

Charleston Neuroscience Institute LLC - Charleston

Charleston, South Carolina, 29414, United States

Location

Palmetto Retina Center

Florence, South Carolina, 29501, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Retina Consultants of Charleston - Mount Pleasant

Mt. Pleasant, South Carolina, 29464, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169-2429, United States

Location

Black Hills Regional Eye Institute (BHREI)

Rapid City, South Dakota, 57701-7374, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Charles Retina Institute PC

Germantown, Tennessee, 38138-2405, United States

Location

Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location

Nashville, Tennessee, 37203-1596, United States

Location

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

Abilene, Texas, 79606, United States

Location

Texas Retina Associates (TRA) - Arlington

Arlington, Texas, 76012-2505, United States

Location

Retina Consultants of Austin PA (RCA) - Central Austin

Austin, Texas, 78705-1023, United States

Location

Austin Retina Associates, PLLC

Austin, Texas, 78705-1169, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

Retina Research Center (RRC)

Austin, Texas, 78750-2302, United States

Location

Retina Consultants of Texas Beaumont

Beaumont, Texas, 77707, United States

Location

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

Bellaire, Texas, 77401, United States

Location

Star Vision Consultants

Burleson, Texas, 76028, United States

Location

Texas Retina Center

Houston, Texas, 77030, United States

Location

Retina Consultants of Texas - Katy

Katy, Texas, 77494, United States

Location

Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location

San Antonio, Texas, 78240-1502, United States

Location

Retinal Consultants of Texas - San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

TX RCTX Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

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

Salt Lake City, Utah, 84107-6767, United States

Location

Wagner Macula & Retina Center - Norfolk, VA Office

Norfolk, Virginia, 23502-3933, United States

Location

Vistar Eye Center Vision and Surgery Specialists

Roanoke, Virginia, 24019, United States

Location

Eye Clinic of Wisconsin

Wausau, Wisconsin, 54403, United States

Location

Buenos Aires Macula

Pilar, Buenos Aires, B1629AHJ, Argentina

Location

Centro Oftalmologico Dr. Charles S.A

Buenos Aires, Buenos Aires F.D., 1121, Argentina

Location

Organizacion Medica de Investigacion OMI

Buenos Aires, Buenos Aires F.D., C1015, Argentina

Location

Fundacion Zambrano - Cirugia Ocular

Buenos Aires, Buenos Aires F.D., C1023AAQ, Argentina

Location

Instituto Oftalmologico de Alta Complejidad

Buenos Aires, Buenos Aires F.D., C1120AAN, Argentina

Location

Oftalmologia Global

Rosario, Santa Fe Province, S2000, Argentina

Location

Centro Privado de Ojos Romagosa SA

Córdoba, X5000AAI, Argentina

Location

Oftar Mendoza Srl Centro Privado de Oftalmologia

Mendoza, M5500GGK, Argentina

Location

Centrovision

Mendoza, M5500, Argentina

Location

Laser Vision Group

Santa Fe, S2126DTO, Argentina

Location

Emanuelli research and development

Arecibo, 612, Puerto Rico

Location

MeSH Terms

Interventions

Axitinib; aflibercept

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 25, 2024
• Study Start: January 29, 2024
• Primary Completion: April 29, 2026
• Study Completion (Estimated): September 27, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

AR (10); US (97); PR (1)