ACTIVE_NOT_RECRUITING

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

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Conditions

Neovascular Age-related Macular DegenerationTyrosine Kinase InhibitorOTX-TKI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-11-27
Study Completion:2027-01-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06495918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Have provided written consent
  1. * Monocular subject or Best Corrected Visual Acuity (BCVA) score of \<20 ETDRS letters or 20/400 in fellow eye at Screening
  2. * Have evidence of a scar, fibrosis, or atrophy of \>50% of the total lesion in the study eye.

Contacts and Locations

Principal Investigator

Dilsher Dhoot, MD
PRINCIPAL_INVESTIGATOR
California Retina Consultants (CRC) - Santa Barbara

Study Locations (Sites)

Associated Retina Consultant
Gilbert, Arizona, 85297
United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
United States
California Retina Consultants
Bakersfield, California, 93309
United States
The Retina Partners
Encino, California, 91436
United States
Retina Consultants of Orange County
Fullerton, California, 92835
United States
Atlantis Eyecare
Huntington Beach, California, 92647
United States
Salehi Retina Institute, Inc., dba Retina Associates of Southern California
Huntington Beach, California, 92647
United States
Kaiser Permanente Division of Research
Oakland, California, 94611
United States
California Retina Consultants
Oxnard, California, 93036
United States
Stanford Health Care - Byers Eye Institute
Palo Alto, California, 94303
United States
Stanford University School of Medicine, Byers Eye Institute
Palo Alto, California, 94303
United States
California Eye Specialists Medical Group, INC
Pasadena, California, 91107
United States
Retinal Consultants Medical Group
Sacramento, California, 95841
United States
Orange County Retina Medical Group
Santa Ana, California, 92705
United States
California Retina Consultants
Santa Barbara, California, 93103
United States
Macula Retina Vitreous Research Institute
Torrance, California, 90503
United States
Bay Area Retina Associates
Walnut Creek, California, 94598
United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
United States
RSC Research, LLC
Denver, Colorado, 80210
United States
Colorado Retina Associates
Lakewood, Colorado, 80228
United States
Retina Consultants, P.C
Manchester, Connecticut, 06042
United States
Retina Group of New England
Waterford, Connecticut, 06385
United States
Advanced Research LLC.
Deerfield Beach, Florida, 33064
United States
Rand Eye Institute
Deerfield Beach, Florida, 33064
United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308
United States
Florida Retina Consultants
Lakeland, Florida, 33805
United States
South Florida Retina Institute
Miami, Florida, 33145
United States
Florida Retina Institude
Orlando, Florida, 32806
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Retina Vitreous Associates of Florida- Saint Petersburg
Saint Petersburg, Florida, 33711
United States
MedEye Associates
South Miami, Florida, 33143
United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617
United States
Southeast Retina Center
Augusta, Georgia, 30909
United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452
United States
Illinois Retina Associates
Oak Park, Illinois, 60304
United States
Springfield Clinic Opthalmology Department
Springfield, Illinois, 62703
United States
Associate Vitreoretinal and Uveitis Consultants
Carmel, Indiana, 46032
United States
Retina Partners Midwest, P.C.
Carmel, Indiana, 46290
United States
Retina Partners Midwest
Indianapolis, Indiana, 46290
United States
Wolfe Clinic PC dba Wolfe Eye Clinic
West Des Moines, Iowa, 50026
United States
The Retina Group of Washington - Chevy Chase
Chevy Chase, Maryland, 20815
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
United States
Retina Specialists - Towson Office
Towson, Maryland, 21204
United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
United States
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435
United States
Mississippi Retina Associates
Madison, Mississippi, 39110
United States
The Retina Institute
Saint Louis, Missouri, 63128
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088
United States
Asheville Eye Associates (AEA) - Asheville
Asheville, North Carolina, 28803
United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
United States
EyeHealth Northwest
Portland, Oregon, 97225
United States
Erie Retina Research
Erie, Pennsylvania, 16507
United States
Palmetto Retina Center, LLC
Aiken, South Carolina, 29802
United States
Charleston Neuroscience Instititute, LLC
Beaufort, South Carolina, 29902
United States
Palmetto Retina Center, LLC
Florence, South Carolina, 29501
United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169
United States
Black Hills Regional Eye Institute, LLP
Rapid City, South Dakota, 57701
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Southeastern Retina Associates PC
Johnson City, Tennessee, 37604
United States
Tennessee Retina, PC
Nashville, Tennessee, 37203
United States
Retina Research Institute of Texas
Abilene, Texas, 79606
United States
Texas Retina Associates
Arlington, Texas, 76012
United States
Austin Research Center for Retina
Austin, Texas, 78705
United States
Austin Retina Associates
Austin, Texas, 78705
United States
Retina Consultants of Texas
Beaumont, Texas, 77707
United States
Retina Consultants of Texas
Bellaire, Texas, 77401
United States
Star Vision Research
Burleson, Texas, 76028
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Texas Retina Center
Houston, Texas, 77030
United States
Retina Consultants of Texas
Katy, Texas, 77494
United States
Retina Consultants of Texas
San Antonio, Texas, 78240
United States
Retina Center of Texas
Southlake, Texas, 76092
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384
United States
Retina Associates of Utah
Salt Lake City, Utah, 84107
United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107
United States
Retina Group of Washington
Fairfax, Virginia, 22031
United States
Vistar Eye Center
Roanoke, Virginia, 24019
United States
Eye Clinic of Wisconsin, SC
Wausau, Wisconsin, 54403
United States

Collaborators and Investigators

Sponsor: Ocular Therapeutix, Inc.

  • Dilsher Dhoot, MD, PRINCIPAL_INVESTIGATOR, California Retina Consultants (CRC) - Santa Barbara

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-27
Study Completion Date2027-01-08

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2027-01-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Neovascular Age-related Macular Degeneration