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NCT07516132RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
850 (estimated)
First submitted
31 Mar 2026
Start date
27 Apr 2026
Primary completion date
1 Aug 2030
Lead sponsor
Ocular Therapeutix, Inc.
NCT number
NCT07516132

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 850
  • From 27 Apr 2026 to the primary completion date, 1 Aug 2030
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1

Other illness

  • History of intraocular inflammation in the study eye
  • 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

Other

  • 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
  • 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.

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Austin Retina Associates
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
California Retina Consultants (CRC)
Coordinator of this site? Confirm its status
BakersfieldUnited StatesRecruiting
Retina Group of Florida - Fort Lauderdale
Coordinator of this site? Confirm its status
Fort LauderdaleUnited StatesRecruiting
Mid Atlantic Retina Specialists
Coordinator of this site? Confirm its status
HagerstownUnited StatesRecruiting
Cumberland Valley Retina Associates
Coordinator of this site? Confirm its status
HagerstownUnited StatesRecruiting
California Retina Consultants CRC
Coordinator of this site? Confirm its status
Santa BarbaraUnited StatesRecruiting
Retina Group of New England
Coordinator of this site? Confirm its status
WaterfordUnited StatesRecruiting
Palmetto Retina Center
Coordinator of this site? Confirm its status
West ColumbiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.