Clinical trial NCT06223958: Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Neovascular Age-Related Macular Degeneration
Tyrosine Kinase Inhibitor
OTX-TKI
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fortrea
name: Duke University
First posted: 2024-01-25
Enrollment: 344
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

Brief 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 Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: Up to 36 Weeks
Secondary outcomes:
Other outcomes:
measure: Incidence and severity of treatment emergent adverse events (AEs)
timeFrame: Up to 104 Weeks
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultants - Gilbert
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Bakersfield
country: United States
facility: CA CRC California Retina Consultants
state: California
city: Encino
country: United States
facility: The Retina Partners - Encino
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County - Fullerton
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eyecare
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center - Irvine
state: California
city: Los Angeles
country: United States
facility: Retina-Vitreous Associates Medical Group - Los Angeles
state: California
city: Modesto
country: United States
facility: CA RCMG Retinal Consultants Medical Group, Inc.
state: California
city: Modesto
country: United States
facility: Retina Sacramento MSO, LLC
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: Oxnard
country: United States
facility: CA CRC California Retina Consultants
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine, Byers Eye Institute
state: California
city: Pasadena
country: United States
facility: Doheny Eye Center
state: California
city: Pasadena
country: United States
facility: AzulVision
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants (CRC) - Santa Barbara
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Center
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates, A Medical Group
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado - Colorado Springs
state: Colorado
city: Denver
country: United States
facility: RSC Research, PLLC
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates (CRA) - Lakewood
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Clearwater
country: United States
facility: The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Deerfield Beach
country: United States
facility: Speciality Retina Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida - Fort Lauderdale
state: Florida
city: Lake Mary
country: United States
facility: Florida Retina Institute - Lake Mary
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants - Lakeland
state: Florida
city: Miami
country: United States
facility: South Florida Retina Institute
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute - Pensacola
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
state: Florida
city: South Miami
country: United States
facility: MedEye Associates - Miami
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida - Tampa
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida LLC Tampa MacDill
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, P.C. - Augusta
state: Georgia
city: Chicago
country: United States
facility: Illinois Eye and Ear Infirmary at UI Health UIC
state: Illinois
city: Chicago
country: United States
facility: Illinois Retina Associates, S.C. - Lincoln Park
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, P.C.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Carmel
country: United States
facility: IN AVRUC Associated Vitreoretinal and Uveitis Consultants
state: Indiana
city: Indianapolis
country: United States
facility: Retina Partners Midwest
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Portland
country: United States
facility: Maine Eye Center - Marginal Way Campus
state: Maine
city: Baltimore
country: United States
facility: The Wilmer Eye Institute
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists - Hagerstown
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants P.C. (ARC) - Royal Oak
state: Michigan
city: Edina
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Baptist Medical Center
state: Mississippi
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Saint Louis
country: United States
facility: Retina Research Institute, LLC
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: The Retina Center Of New Jersey, LLC - Bloomfield
state: New Jersey
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants (VRC) - Hauppauge
state: New York
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central New York
state: New York
city: Shirley
country: United States
facility: NY LIVRC Long Island Vitreoretinal Consultants
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates (AEA) - Retinal Office
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System - Duke Eye Center Of North Durham
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland, Inc. - Beachwood
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Youngstown
country: United States
facility: Retina Associates of Cleveland, Inc. - Youngstown
state: Ohio
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Aiken
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Beaufort
country: United States
facility: Charleston Neuroscience Institute LLC - Beaufort
state: South Carolina
city: Beaufort
country: United States
facility: SC CNI Retina Consultants of Charleston
state: South Carolina
city: Charleston
country: United States
facility: Charleston Neuroscience Institute LLC - Charleston
state: South Carolina
city: Florence
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Mount Pleasant
country: United States
facility: Retina Consultants of Charleston - Mount Pleasant
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute (BHREI)
state: South Dakota
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Germantown
country: United States
facility: Charles Retina Institute PC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location
state: Tennessee
city: Abilene
country: United States
facility: West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA)
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates (TRA) - Arlington
state: Texas
city: Austin
country: United States
facility: Retina Consultants of Austin PA (RCA) - Central Austin
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates, PLLC
state: Texas
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Austin
country: United States
facility: Retina Research Center (RRC)
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas Beaumont
state: Texas
city: Bellaire
country: United States
facility: Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)
state: Texas
city: Burleson
country: United States
facility: Star Vision Consultants
state: Texas
city: Houston
country: United States
facility: Texas Retina Center
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas - Katy
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas - San Antonio Medical Center
state: Texas
city: San Antonio
country: United States
facility: TX RCTX Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah, P.C - Intermountain Medical Center Location
state: Utah
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center - Norfolk, VA Office
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center Vision and Surgery Specialists
state: Virginia
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin
state: Wisconsin
city: Pilar
country: Argentina
facility: Buenos Aires Macula
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Oftalmologico Dr. Charles S.A
state: Caba
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion OMI
state: Caba
city: Buenos Aires
country: Argentina
facility: Fundacion Zambrano - Cirugia Ocular
state: Caba
city: Buenos Aires
country: Argentina
facility: Instituto Oftalmologico de Alta Complejidad
state: Caba
city: Rosario
country: Argentina
facility: Oftalmologia Global
state: Santa Fe
city: Cordoba
country: Argentina
facility: Centro Privado de Ojos Romagosa SA
city: Mendoza
country: Argentina
facility: Oftar Mendoza Srl Centro Privado de Oftalmologia
city: Mendoza
country: Argentina
facility: Centrovision
city: Santa Fe
country: Argentina
facility: Laser Vision Group
city: Arecibo
country: Puerto Rico
facility: Emanuelli research and development
Study officials:
References: