Clinical Trials in the USA / NCT06223958
Active, not recruiting
Phase 3
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
Condition(s) studied
Neovascular Age-Related Macular Degeneration
Investigational drug(s) / intervention(s)
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
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 | Status |
|---|---|---|---|
| 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
Other trials for the same condition
Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME
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Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
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 NCT06223958 on ClinicalTrials.gov ↗ ← All trials in the USA