Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
Lead Sponsor:
Ocular Therapeutix, Inc.
Collaborating Sponsors:
Fortrea
Duke University
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 8 2027
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT06495918
Start Date
November 27 2024
End Date
January 8 2027
Last Update
June 17 2025
Active Locations (97)
Enter a location and click search to find clinical trials sorted by distance.
1
Associated Retina Consultant
Gilbert, Arizona, United States, 85297
2
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States, 85020
3
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85053
4
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States, 85255