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 — DRUG
    Intravitreal 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

Locations (1)

FacilityCityStateZIPSite coordinators
California Retina Consultants (CRC)Santa BarbaraCalifornia93103
Dilsher Dhoot, MD
781-357-4000

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