Clinical trial NCT06495918: 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
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: 2024-07-11
Enrollment: 825
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to 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 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
* Have provided written consent

Exclusion Criteria:

* Monocular subject or Best Corrected Visual Acuity (BCVA) score of \<20 ETDRS letters or 20/400 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: Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultant
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eyecare
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute, Inc., dba Retina Associates of Southern California
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Palo Alto
country: United States
facility: Stanford Health Care - Byers Eye Institute
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: California Eye Specialists Medical Group, INC
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
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
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Research Institute
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Denver
country: United States
facility: RSC Research, LLC
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Manchester
country: United States
facility: Retina Consultants, P.C
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Deerfield Beach
country: United States
facility: Advanced Research LLC.
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Miami
country: United States
facility: South Florida Retina Institute
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institude
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida- Saint Petersburg
state: Florida
city: South Miami
country: United States
facility: MedEye Associates
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Opthalmology Department
state: Illinois
city: Carmel
country: United States
facility: Associate Vitreoretinal and Uveitis Consultants
state: Indiana
city: Carmel
country: United States
facility: Retina Partners Midwest, P.C.
state: Indiana
city: Indianapolis
country: United States
facility: Retina Partners Midwest
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Clinic PC dba Wolfe Eye Clinic
state: Iowa
city: Chevy Chase
country: United States
facility: The Retina Group of Washington - Chevy Chase
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Towson
country: United States
facility: Retina Specialists - Towson Office
state: Maryland
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Minneapolis
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Madison
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of CNY, PC
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates (AEA) - Asheville
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Aiken
country: United States
facility: Palmetto Retina Center, LLC
state: South Carolina
city: Beaufort
country: United States
facility: Charleston Neuroscience Instititute, LLC
state: South Carolina
city: Florence
country: United States
facility: Palmetto Retina Center, LLC
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute, LLP
state: South Dakota
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Johnson City
country: United States
facility: Southeastern Retina Associates PC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Burleson
country: United States
facility: Star Vision Research
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Texas Retina Center
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Fairfax
country: United States
facility: Retina Group of Washington
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin, SC
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Organización Médica de Investigación (OMI)
city: Buenos Aires
country: Argentina
facility: Centro Privado de Ojos
city: Caba
country: Argentina
facility: Buenos Aires Macula
city: Caba
country: Argentina
facility: Instituto Oftalmologico de Buenos Aires SA - OFTALMOS
city: Caba
country: Argentina
facility: Fundacion Zambrano - Cirugia Ocular
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Charles Research Center (Centro Oftalmologico Dr. Charles S.A)
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares
city: Ciudad de Mendoza
country: Argentina
facility: Centro Vision S.A.
city: Mendoza
country: Argentina
facility: Oftar Mendoza Srl Centro Privado de Oftalmologia
city: Rosario
country: Argentina
facility: Laser Vision Group
city: Albury
country: Australia
facility: Albury Eye Clinic
state: New South Wales
city: Parramatta
country: Australia
facility: Marsden Eye Specialists (MES) - Parramatta
state: New South Wales
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center, LLC
Study officials:
affiliation: California Retina Consultants (CRC) - Santa Barbara
name: Dilsher Dhoot, MD
role: PRINCIPAL_INVESTIGATOR
References: