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

NCT06223958 · tracked via the Priya Life Science USA tracker

Sponsor

Ocular Therapeutix, Inc.

Phase

Phase 3

Started

2024-01-29

Last updated

2025-04-18

Condition(s) studied

Neovascular Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

OTX-TKI (axitinib implant)Aflibercept

OTX-TKI (axitinib implant): Intravitreal Injection of OTX-TKI (axitinib implant)

Aflibercept: Injection of 2mg (0.05mL) 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

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.

Primary outcome measure(s)

Best corrected visual acuity (BCVA) — Up to 36 Weeks
Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss

Trial sites (108)

Facility	City	Region
Associated Retina Consultants - Gilbert	Gilbert	Arizona
Associated Retina Consultants - Phoenix	Phoenix	Arizona
Retinal Research Institute	Phoenix	Arizona
Retina Macula Institute of Arizona	Scottsdale	Arizona
CA CRC California Retina Consultants	Bakersfield	California
The Retina Partners - Encino	Encino	California
Retina Consultants of Orange County - Fullerton	Fullerton	California
Atlantis Eyecare	Huntington Beach	California
Lakeside Vision Center - Irvine	Irvine	California
Retina-Vitreous Associates Medical Group - Los Angeles	Los Angeles	California
CA RCMG Retinal Consultants Medical Group, Inc.	Modesto	California
Retina Sacramento MSO, LLC	Modesto	California
Kaiser Permanente Division of Research	Oakland	California
CA CRC California Retina Consultants	Oxnard	California
Stanford University School of Medicine, Byers Eye Institute	Palo Alto	California
Doheny Eye Center	Pasadena	California
AzulVision	Pasadena	California
Orange County Retina Medical Group	Santa Ana	California
California Retina Consultants (CRC) - Santa Barbara	Santa Barbara	California
Macula Retina Vitreous Center	Torrance	California
Bay Area Retina Associates, A Medical Group	Walnut Creek	California
Retina Consultants of Southern Colorado - Colorado Springs	Colorado Springs	Colorado
RSC Research, PLLC	Denver	Colorado
Colorado Retina Associates (CRA) - Lakewood	Lakewood	Colorado
Retina Group of New England, PC	Waterford	Connecticut
The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)	Clearwater	Florida
Rand Eye Institute	Deerfield Beach	Florida
Speciality Retina Center	Deerfield Beach	Florida
Retina Group of Florida - Fort Lauderdale	Fort Lauderdale	Florida
Florida Retina Institute - Lake Mary	Lake Mary	Florida
Florida Retina Consultants - Lakeland	Lakeland	Florida
South Florida Retina Institute	Miami	Florida
Retina Specialty Institute - Pensacola	Pensacola	Florida
MedEye Associates - Miami	South Miami	Florida
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg	St. Petersburg	Florida
Retina Vitreous Associates of Florida - Tampa	Tampa	Florida
Retina Associates of Florida LLC Tampa MacDill	Tampa	Florida
Southeast Retina Center, P.C. - Augusta	Augusta	Georgia
Illinois Eye and Ear Infirmary at UI Health UIC	Chicago	Illinois
Illinois Retina Associates, S.C. - Lincoln Park	Chicago	Illinois

+ 68 more sites — see the full list on the official registry below.

More Ocular Therapeutix, Inc. trials in the USA

A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy Recruiting

Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study Recruiting

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration Active, not recruiting

Other trials for the same condition

Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA] Active, not recruiting

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD) Recruiting

Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT] Active, not recruiting

A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration Active, not recruiting

A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) 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 NCT06223958 on ClinicalTrials.gov ↗ ← All trials in the USA