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Recruiting

NCT Number: NCT07516132

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

California Retina Consultants (CRC), Bakersfield, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTX-TKI

Drug

Intravitreal Injection of OTX-TKI

Primary outcomes

  1. 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

    Number of events

  2. 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

    Time frame: from Baseline (Day 1) through Week 144

    Percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Project Manager

CONTACT

[email protected]

781-357-4000

Nichole Wilkes

CONTACT

[email protected]

770-375-1020

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Collaborators

  • Duke Reading Center
  • Fortrea

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 7, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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