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 Bakersfield, California.

Sponsor
Ocular Therapeutix, Inc.
Study ID
NCT07516132
Phase
PHASE3
Status
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

First listed
Apr 7, 2026
Start date
Apr 27, 2026
Status verified
Jun 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 (8)

FacilityCityStateZIPSite coordinators
California Retina Consultants (CRC)BakersfieldCalifornia93309
Luis Lopez
[email protected]
661-524-0162
Dilsher Dhoot, MD (PRINCIPAL_INVESTIGATOR)
California Retina Consultants (CRC)Santa BarbaraCalifornia93103
Dilsher Dhoot, MD
[email protected]
781-357-4000
Retina Group of New EnglandWaterfordConnecticut06385
Ashley Parent
[email protected]
860-444-1292
Nauman A Chaudhry, MD (PRINCIPAL_INVESTIGATOR)
Retina Group of Florida - Fort LauderdaleFort LauderdaleFlorida33308
Eduardo Uchiyama, MD
[email protected]
954-776-6800
Eduardo Uchiyama, MD (PRINCIPAL_INVESTIGATOR)
Cumberland Valley Retina AssociatesHagerstownMaryland21740
Brittany Carson
[email protected]
301-665-1712
Allen Hu, MD (PRINCIPAL_INVESTIGATOR)
Mid Atlantic Retina SpecialistsHagerstownMaryland21740
Adam Gerstenblith, MD
[email protected]
240-313-9500
Adam Gerstenblith, MD (PRINCIPAL_INVESTIGATOR)
Palmetto Retina CenterWest ColumbiaSouth Carolina29619
Nitin Nigam, MD
[email protected]
803-867-7059
Nitin Nigam, MD (PRINCIPAL_INVESTIGATOR)
Austin Retina AssociatesAustinTexas78705
Robert William Wong, MD
512-451-0103
Robert William Wong, MD (PRINCIPAL_INVESTIGATOR)

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California Retina Consultants (CRC)· Bakersfield, CACalifornia Retina Consultants (CRC)· Santa Barbara, CARetina Group of New England· Waterford, CTRetina Group of Florida - Fort Lauderdale· Fort Lauderdale, FLCumberland Valley Retina Associates· Hagerstown, MDMid Atlantic Retina Specialists· Hagerstown, MD

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