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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorOcular Therapeutix, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • OTX-TKI

Treatment groups

850 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ocular Therapeutix, Inc.

Lead sponsor

Fortrea

Collaborator

Duke Reading Center

Collaborator