Long-term safety test of the Axitinib implant for people with neovascular AMD who finished prior OTX-TKI studies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study follows participants with neovascular AMD who previously completed two specific OTX-TKI trials. The goal is to monitor long-term safety of the Axitinib implant given via injection in the eye. Eligible participants must have passed the earlier studies, have good eye clarity for imaging, and comply with all visits. Key exclusions include recent intraocular infections, prior intraocular inflammation, certain macular abnormalities, or any condition that would increase risk. The study is led by Ocular Therapeutix with Fortrea and Duke Reading Center as collaborators, at select clinical sites in California and Connecticut.

Why it matters

Who can join: the full rules

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.

Where it's running

• California Retina Consultants (CRC)
  Bakersfield, California, United States Recruiting
• California Retina Consultants (CRC)
  Santa Barbara, California, United States Recruiting
• Retina Group of New England
  Waterford, Connecticut, United States Recruiting
• Retina Group of Florida - Fort Lauderdale
  Fort Lauderdale, Florida, United States Recruiting
• Cumberland Valley Retina Associates
  Hagerstown, Maryland, United States Recruiting
• Mid Atlantic Retina Specialists
  Hagerstown, Maryland, United States Recruiting

Study contacts

• Principal investigator: Dilsher Dhoot, MD — California Retina Consultants (CRC)-Bakersfield
• Study coordinator: Clinical Project Manager
• Email: clinicalaffairs@ocutx.com
• Phone: 781-357-4000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• OTX-TKI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.