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

Running, not enrolling · Phase 3

Conditions studied: Neovascular Age-Related Macular Degeneration

In brief

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration

Key facts

Study ID

NCT06223958

Run by

Ocular Therapeutix, Inc.

People needed

344

Starts

2024-01-29

Expected to finish

2027-09-27

Last updated by the study team

2025-04-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Associated Retina Consultants - Phoenix — Phoenix, Arizona, United States
• Retinal Research Institute — Phoenix, Arizona, United States
• Retina Macula Institute of Arizona — Scottsdale, Arizona, United States
• CA CRC California Retina Consultants — Bakersfield, California, United States
• The Retina Partners - Encino — Encino, California, United States
• Retina Consultants of Orange County - Fullerton — Fullerton, California, United States
• Atlantis Eyecare — Huntington Beach, California, United States
• Lakeside Vision Center - Irvine — Irvine, California, United States
• Retina-Vitreous Associates Medical Group - Los Angeles — Los Angeles, California, United States
• CA RCMG Retinal Consultants Medical Group, Inc. — Modesto, California, United States
• Retina Sacramento MSO, LLC — Modesto, California, United States
• Kaiser Permanente Division of Research — Oakland, California, United States
• CA CRC California Retina Consultants — Oxnard, California, United States
• Stanford University School of Medicine, Byers Eye Institute — Palo Alto, California, United States
• Doheny Eye Center — Pasadena, California, United States
• AzulVision — Pasadena, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• California Retina Consultants (CRC) - Santa Barbara — Santa Barbara, California, United States
• Macula Retina Vitreous Center — Torrance, California, United States
• Bay Area Retina Associates, A Medical Group — Walnut Creek, California, United States
• Retina Consultants of Southern Colorado - Colorado Springs — Colorado Springs, Colorado, United States
• RSC Research, PLLC — Denver, Colorado, United States
• Colorado Retina Associates (CRA) - Lakewood — Lakewood, Colorado, United States
• Retina Group of New England, PC — Waterford, Connecticut, United States
• Associated Retina Consultants - Gilbert — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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