Search / 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

Launched by OCULAR THERAPEUTIX, INC. · Jan 24, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Neovascular Age Related Macular Degeneration Tyrosine Kinase Inhibitor Otx Tki

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.

Trial Officials

Dilsher Dhoot, MD

Principal Investigator

California Retina Consultants (CRC) - Santa Barbara

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.

Locations

Chesterfield, Missouri, 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

Huntington Beach, 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

Edina, Minnesota, United States

Liverpool, New York, 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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0