Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration
Launched by OCULAR THERAPEUTIX, INC. · Jan 24, 2024
Trial Information
Current as of July 03, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment called the OTX-TKI implant, which delivers a medication called axitinib directly into the eye. The goal is to see how effective and safe this treatment is for people with a condition known as neovascular age-related macular degeneration (nAMD). This condition can cause vision loss and is more common in older adults. The trial is currently looking for participants who are at least 50 years old and have not received any prior treatment for nAMD. To be eligible, participants should have a good level of vision at the start of the study.
If you join this trial, you will receive the OTX-TKI implant and will be monitored closely to see how well you respond to the treatment. The study aims to ensure that the implant is not only effective in improving vision but also safe for use. It’s important to know that individuals with certain eye conditions or those who have significant vision loss in one eye may not qualify for this study.
Gender
ALL
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.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of eye diseases and conditions. Leveraging advanced drug delivery technologies, the company aims to improve patient outcomes by providing sustained-release formulations that enhance the effectiveness of existing treatments while minimizing the burden of frequent dosing. With a robust pipeline of product candidates targeting various ocular disorders, Ocular Therapeutix is committed to addressing unmet medical needs and advancing the standard of care in ophthalmology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Detroit, Michigan, United States
Springfield, Illinois, United States
Santa Ana, California, United States
Chesterfield, Missouri, United States
Baltimore, Maryland, United States
Sioux Falls, South Dakota, United States
Cleveland, Ohio, United States
The Woodlands, Texas, United States
Ladson, South Carolina, United States
Hagerstown, Maryland, United States
Oak Forest, Illinois, United States
Florence, South Carolina, United States
Phoenix, Arizona, United States
Pasadena, California, United States
Huntington Beach, California, United States
Oakland, California, United States
Deerfield Beach, Florida, United States
West Des Moines, Iowa, United States
Austin, Texas, United States
Waterford, Connecticut, United States
Erie, Pennsylvania, United States
Burleson, Texas, United States
Encino, California, United States
Chicago, Illinois, United States
Houston, Texas, United States
Edina, Minnesota, United States
Liverpool, New York, United States
Katy, Texas, United States
Santa Barbara, California, United States
Reno, Nevada, United States
Bellaire, Texas, United States
Walnut Creek, California, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Modesto, California, United States
Oxnard, California, United States
Pasadena, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Fort Lauderdale, Florida, United States
Lake Mary, Florida, United States
Lakeland, Florida, United States
Pensacola, Florida, United States
Saint Petersburg, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Portland, Maine, United States
Hagerstown, Maryland, United States
Jackson, Mississippi, United States
Saint Louis, Missouri, United States
Bloomfield, New Jersey, United States
Asheville, North Carolina, United States
Aiken, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Arlington, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Roanoke, Virginia, United States
Arecibo, , Puerto Rico
Scottsdale, Arizona, United States
Wausau, Wisconsin, United States
Miami, Florida, United States
Pheonix, Arizona, United States
Bakersfield, California, United States
Fullerton, California, United States
Irvine, California, United States
Modesto, California, United States
Palo Alto, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Deerfield Beach, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Royal Oak, Michigan, United States
Hauppauge, New York, United States
Shirley, New York, United States
Durham, North Carolina, United States
Youngstown, Ohio, United States
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Mount Pleasant, South Carolina, United States
Beaumont, Texas, United States
San Antonio, Texas, United States
Pilar, Buenos Aires, Argentina
Buenos Aires, Caba, Argentina
Buenos Aires, Caba, Argentina
Buenos Aires, Caba, Argentina
Buenos Aires, Caba, Argentina
Rosario, Santa Fe, Argentina
Cordoba, , Argentina
Mendoza, , Argentina
Mendoza, , Argentina
Santa Fe, , Argentina
Tampa, Florida, United States
Beachwood, Ohio, United States
Beaufort, South Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported