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Clinical Trials in Australia / NCT06495918
Active, not recruiting Phase 3

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

NCT06495918 · tracked via the Priya Life Science Australia tracker
Sponsor
Ocular Therapeutix, Inc
Phase
Phase 3
Started
2024-11-27
Last updated
2025-06-17

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

OTX-TKI →Aflibercept →Aflibercept →

OTX-TKI: Intravitreal Injection of OTX-TKI

Aflibercept: Intravitreal Injection of 2mg of aflibercept

Aflibercept: Intravitreal Injection of 8mg of aflibercept

Study summary

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (97)

FacilityCityRegionStatus
Associated Retina Consultant Gilbert Arizona
Associated Retina Consultants, Ltd. Phoenix Arizona
Retinal Research Institute, LLC Phoenix Arizona
Retina Macula Institute of Arizona Scottsdale Arizona
California Retina Consultants Bakersfield California
The Retina Partners Encino California
Retina Consultants of Orange County Fullerton California
Atlantis Eyecare Huntington Beach California
Salehi Retina Institute, Inc., dba Retina Associates of Southern California Huntington Beach California
Kaiser Permanente Division of Research Oakland California
California Retina Consultants Oxnard California
Stanford Health Care - Byers Eye Institute Palo Alto California
Stanford University School of Medicine, Byers Eye Institute Palo Alto California
California Eye Specialists Medical Group, INC Pasadena California
Retinal Consultants Medical Group Sacramento California
Orange County Retina Medical Group Santa Ana California
California Retina Consultants Santa Barbara California
Macula Retina Vitreous Research Institute Torrance California
Bay Area Retina Associates Walnut Creek California
Retina Consultants of Southern Colorado Colorado Springs Colorado
RSC Research, LLC Denver Colorado
Colorado Retina Associates Lakewood Colorado
Retina Consultants, P.C Manchester Connecticut
Retina Group of New England Waterford Connecticut
Advanced Research LLC. Deerfield Beach Florida
Rand Eye Institute Deerfield Beach Florida
Retina Group of Florida Fort Lauderdale Florida
Florida Retina Consultants Lakeland Florida
South Florida Retina Institute Miami Florida
Florida Retina Institude Orlando Florida
Retina Specialty Institute Pensacola Florida
MedEye Associates South Miami Florida
Retina Vitreous Associates of Florida- Saint Petersburg St. Petersburg Florida
Retina Vitreous Associates of Florida Tampa Florida
Southeast Retina Center Augusta Georgia
University Retina and Macula Associates, PC Oak Forest Illinois
Illinois Retina Associates Oak Park Illinois
Springfield Clinic Opthalmology Department Springfield Illinois
Associate Vitreoretinal and Uveitis Consultants Carmel Indiana
Retina Partners Midwest, P.C. Carmel Indiana

+ 57 more sites — see the full list on the official registry below.

Other trials for the same condition

Extension Study for the Port Delivery System With Ranibizumab (Portal) Recruiting
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06495918 on ClinicalTrials.gov ↗ ← All trials in Australia