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
Part of paid clinical trials in Santa Barbara, California.
- Sponsor
- Ocular Therapeutix, Inc.
- Study ID
- NCT07516132
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- OTX-TKI — DRUGIntravitreal Injection of OTX-TKI
Study Details
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
Key Dates
- Start date
- Apr 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Aug 1, 2030
- Completion
- Aug 1, 2030
Study Design
- Enrollment
- 850 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: OTX-TKI
Primary Outcome Measure
Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144 [ Time Frame: from Baseline (Day 1) through Week 144 ]
Central Contacts
- Clinical Project Manager781-357-4000
- Nichole Wilkes770-375-1020
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| California Retina Consultants (CRC) | Santa Barbara | California | 93103 |
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