Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (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

NCT06495918

Run by

Ocular Therapeutix, Inc.

People needed

825

Starts

2024-11-27

Expected to finish

2027-01-08

Last updated by the study team

2025-06-17

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Associated Retina Consultants, Ltd. — Phoenix, Arizona, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Retina Macula Institute of Arizona — Scottsdale, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Atlantis Eyecare — Huntington Beach, California, United States
• Salehi Retina Institute, Inc., dba Retina Associates of Southern California — Huntington Beach, California, United States
• Kaiser Permanente Division of Research — Oakland, California, United States
• California Retina Consultants — Oxnard, California, United States
• Stanford Health Care - Byers Eye Institute — Palo Alto, California, United States
• Stanford University School of Medicine, Byers Eye Institute — Palo Alto, California, United States
• California Eye Specialists Medical Group, INC — Pasadena, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Macula Retina Vitreous Research Institute — Torrance, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States
• RSC Research, LLC — Denver, Colorado, United States
• Colorado Retina Associates — Lakewood, Colorado, United States
• Retina Consultants, P.C — Manchester, Connecticut, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Advanced Research LLC. — Deerfield Beach, Florida, United States
• Associated Retina Consultant — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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