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

Recruiting now · Phase 3

Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD)

In brief

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 facts

Study ID

NCT07516132

Run by

Ocular Therapeutix, Inc.

People needed

850

Starts

2026-04-27

Expected to finish

2030-08-01

Last updated by the study team

2026-07-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• California Retina Consultants (CRC) — Bakersfield, California, United States (enrolling)
• California Retina Consultants (CRC) — Santa Barbara, California, United States (enrolling)
• Retina Group of New England — Waterford, Connecticut, United States (enrolling)
• Retina Group of Florida - Fort Lauderdale — Fort Lauderdale, Florida, United States (enrolling)
• Cumberland Valley Retina Associates — Hagerstown, Maryland, United States (enrolling)
• Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States (enrolling)
• Palmetto Retina Center — West Columbia, South Carolina, United States (enrolling)
• Austin Retina Associates — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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