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
← catalyst calendarNCT07516132 · readout in 1,442 d
Sponsored by Ocular Therapeutix, Inc. (industry) · OCUL — their whole pipeline →. With Fortrea, Duke Reading Center.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
850estimated
Sites
8
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-27 | actual | When the study began enrolling |
| Primary completion | 2030-08-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-08-01 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Neovascular Age-Related Macular Degeneration (nAMD)
Intervention
- Drug: OTX-TKI
Primary outcomes
what the primary-completion date above is the date OFIncidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144
measured from Baseline (Day 1) through Week 144
Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144
measured from Baseline (Day 1) through Week 144
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