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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

RecruitingPhase 3

A Phase 3b, Multicenter, Open-Label, Extension 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

Who can join

Ages 50 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96
* Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging
* Are able and willing to comply with all study requirements and visits
* Have provided written informed consent

Exclusion Criteria:

* Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1
* History of intraocular inflammation in the study eye
* Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular
* Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results
* Female participants who are pregnant (had a positive urine test at the Baseline visit \[Day 1\]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.

About the study

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

What is being tested

Sponsor: Ocular Therapeutix, Inc. · Participants: 850 · Started: Apr 27, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07516132

Locations in the U.S.

CaliforniaCalifornia Retina Consultants (CRC), Bakersfield
California Retina Consultants (CRC), Santa Barbara
ConnecticutRetina Group of New England, Waterford
FloridaRetina Group of Florida - Fort Lauderdale, Fort Lauderdale
MarylandCumberland Valley Retina Associates, Hagerstown
Mid Atlantic Retina Specialists, Hagerstown
South CarolinaPalmetto Retina Center, West Columbia
TexasAustin Retina Associates, Austin

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.